Dexcom Near-Death Injuries

FDA MAUDE Database Adverse Event Reports

Report generated on November 06, 2025 at 04:54 PM

Total Reports Found: 296
Date Range: 2023-01-10 to 2025-09-17
Note: FDA MAUDE data typically has a delay of several weeks to months before reports become publicly available.
Report #1 - 3004753838-2025-246822 CRITICAL
View on MAUDE
Date of Event N/A
Patient Gender Female
Patient Age 66 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. THE PATIENT REPORTED THAT SHE INSERTED A NEW WEARABLE DEVICE ON THE MORNING OF (B)(6) 2025. LATER THAT AFTERNOON, WHILE TRAVELING IN A VEHICLE, SHE EXPERIENCED HYPOGLYCEMIA AND LOST CONSCIOUSNESS. THE LAST GLUCOSE READING SHE RECALLED BEFORE LOSING CONSCIOUSNESS WAS 101 MG/DL. HER HUSBAND PROMPTLY PULLED THE VEHICLE OVER TO THE SIDE OF THE ROAD AND ADMINISTERED BAQSIMI (NASAL GLUCAGON), AND THE PATIENT REGAINED CONSCIOUSNESS. THEY DECIDED NOT TO SEEK HOSPITAL CARE AS SHE ALREADY REGAINED CONSCIOUSNESS AND HER CONDITION BEGAN TO IMPROVE SHORTLY THEREAFTER. THE PATIENT ALSO MENTIONED THAT NEITHER HER DEXCOM APP OR HER OMNIPOD 5 INSULIN PUMP ISSUED ANY ALERTS DURING THE EPISODE, DESPITE ALL NOTIFICATIONS AND ALARMS BEING ENABLED AND SET CORRECTLY. AT THE TIME WHEN PATIENT REPORTED THE ISSUE SHE WAS DOING FINE. DATA HAS BEEN REQUESTED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #2 - 3004753838-2025-274450 CRITICAL
View on MAUDE
Date of Event 2025-09-17
Patient Gender Female
Patient Age 20 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT. THE PATIENT REPORTED NOT GETTING ANY READINGS AND THE SENSOR HAD A ¿BRIEF SENSOR ISSUE¿ AND THEN THE CGM VALUES WOULD RETURN INTERMITTENTLY. THE REPORTER STATED SHE WENT TO VISIT THE PATIENT AT HER DORM ROOM AND FOUND HER UNRESPONSIVE. THE REPORTER WAS UNAWARE OF THE CGM HAD READING ON IT BEFORE THE PATIENT FELL ASLEEP, BUT THE CGM WAS STATING TO ¿REPLACE SENSOR NOW¿ WITH NO OTHER INFORMATION PROVIDED. THEREFORE, THE PATIENT¿S CGM VALUE WAS UNKNOWN. THE PATIENT¿S BG METER READING WAS TAKEN TWICE; THE FIRST TEST WAS 63 MG/DL AND THE SECOND WAS 43 MG/DL. THE PATIENT¿S ROOMMATE CALLED 911. BY THIS TIME, THE PATIENT WOKE UP BUT WAS SLUGGISH. THE PATIENT¿S ROOMMATE GAVE THE PATIENT JUICE WHILE WAITING FOR EMERGENCY MEDICAL SERVICES (EMS). AT THE TIME OF REPORT, EMS HAD NOT YET ARRIVED. THE REPORTER ENDED THE CALL WITH DEXCOM; THEREFORE, NO FURTHER EVENT DETAILS WERE PROVIDED. ATTEMPTS TO REACH THE REPORTER BACK FOR FURTHER EVENT DETAILS WERE UNSUCCESSFUL. DATA HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #3 - 3004753838-2025-273794 CRITICAL
View on MAUDE
Date of Event 2025-09-15
Patient Gender Male
Patient Age 49 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT EXPERIENCED A LOSS OF CONSCIOUSNESS AND SUSTAINED A HEAD INJURY AS A RESULT OF THE FALL. EMERGENCY MEDICAL SERVICES WERE CONTACTED BY THE PATIENT¿S MOTHER-IN-LAW, AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL VIA AMBULANCE. UPON ARRIVAL, A FINGERSTICK BLOOD GLUCOSE TEST REVEALED A CGM READING OF 400 MG/DL, WHILE THE BG READING WAS 60 MG/DL, INDICATING A DISCREPANCY BETWEEN THE TWO VALUES. THE PATIENT WAS TREATED WITH IV FLUIDS FOR REHYDRATION AND MORPHINE FOR PAIN MANAGEMENT. ADDITIONALLY, THE PATIENT RECEIVED EIGHT STAPLES TO CLOSE THE HEAD WOUND. THE PATIENT WAS DISCHARGED TWO DAYS AFTER THE EVENT. AT THE TIME OF THE REPORT, THE PATIENT WAS FINE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #4 - 3004753838-2025-272448 CRITICAL
View on MAUDE
Date of Event 2025-09-15
Patient Gender Female
Patient Age 44 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM WHICH IS AN OFF-LABEL USAGE OF THE DEVICE ON (B)(6) 2025. ON 09/15/2025, IT WAS REPORTED THAT THE PATIENT WAS WORKING IN THE YARD WHEN SHE FELT DIZZY AND NAUSEOUS. SHE CHECKED HER CGM DEVICE AND IT WAS IN A ¿BRIEF SENSOR ISSUE¿ STATE. NO BG METER VALUE WAS TAKEN. AT AN UNSPECIFIED TIME LATER, THE PATIENT WAS FOUND UNCONSCIOUS IN THE YARD. EMERGENCY MEDICAL SERVICES (EMS) WAS CALLED WHEN THEY ARRIVED THE PATIENT¿S BG METER REDING WAS 38 MG/DL. THE CGM WAS PROVIDING VALUES AT THIS TIME AND WAS READING 58 MG/DL. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM (ER). THE PATIENT WAS TREATED WITH (8) VIALS OF LIQUID GLUCOSE AND FOOD. AT THE ER, THE PATIENT¿S BG METER READING WAS 70 MG/DL AND THE CGM WAS BACK IN A ¿BRIEF SENSOR ERROR¿ STATE AT THIS TIME. A RECHECK OF THE PATIENT¿S BG METER READING WAS BETWEEN 68-70 MG/DL AND THE PATIENT REGAINED CONSCIOUSNESS IN THE ER. UPON WAKING UP, SHE HAD A HEADACHE, WAS DISORIENTED AND VOMITING. THE PATIENT¿S CGM DEVICE WAS REMOVED. THE PATIENT WAS GIVEN A SANDWICH AND JUICE AND WAS THEN TREATED WITH INSULIN. BLOOD WORK WAS ALSO DRAWN. AFTER EATING, THE PATIENT¿S BG METER READING WAS 81 MG/DL AND THE PATIENT WAS DISCHARGED HOME AFTER APPROXIMATELY 4 HOURS. THE PATIENT REPLACED HER SENSOR AND REPORTED THE NEW SENSOR WAS WORKING PROPERLY. THE PATIENT WAS FEELING BETTER AT THE TIME OF REPORT. DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS CONFIRMED VIA DATA. THE PROBABLE CAUSE FOR NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE WAS DETERMINED TO BE SENSOR NOISE. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #5 - 3004753838-2025-273838 CRITICAL
View on MAUDE
Date of Event 2025-09-14
Patient Gender N/A
Patient Age N/A
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. ACCORDING TO THE PATIENT, ON APPROXIMATELY (B)(6) 2025, THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT. AROUND 8:00 PM, THE PATIENT TOOK OUT THE GARBAGE AND THEN CAME BACK INSIDE TO THE COUCH. SHE THEN BECAME UNRESPONSIVE, AND EMS WAS CALLED. THE PATIENT REPORTED THAT PRIOR TO THIS, HER CGM WAS READING 130 MG/DL AND SHE NEVER RECEIVED AN ALERT THAT HER BLOOD GLUCOSE (BG) LEVEL HAD DROPPED (LOW THRESHOLD WAS SET FOR 80 MG/DL). NO BG METER COMPARISON VALUE WAS TAKEN. ONCE EMS ARRIVED, THE PATIENT¿S BG METER READING WAS LOW (LESS THAN 40 MG/DL), WHICH WAS REPORTED TO BE UNDER 25 MG/DL. SHE WAS TREATED WITH INTRAVENOUS (IV) GLUCOSE. SHE REGAINED CONSCIOUSNESS AFTER APPROXIMATELY 5 MINUTES AFTER RECEIVING TREATMENT. THE PATIENT REFUSED TO BE TAKEN TO THE HOSPITAL BY EMS. THE PATIENT REMAINED HOME AND MONITORED HER BG LEVEL EVERY HOUR BY FINGERSTICK. EMS ALSO ADVISED THE PATIENT TO EAT AND SHE WAS GIVEN SOME FAST-ACTING INSULIN. IT WAS APPROXIMATELY 45 MINUTES AFTER SHE REGAINED CONSCIOUSNESS THAT EMS LEFT. THE FOLLOWING DAY, THE PATIENT REPORTED TO BE SHAKY BUT OKAY. AT THE TIME OF REPORT, THE PATIENT WAS LETHARGIC. DATA HAS BEEN REQUESTED BUT IS PENDING EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Report #6 - 3004753838-2025-270516 CRITICAL
View on MAUDE
Date of Event 2025-09-14
Patient Gender Male
Patient Age 82 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, AROUND 430AM, THE PATIENT REPORTER STATED HER FATHER WAS NOT COHERENT AND UNRESPONSIVE WITH HIS EYES WIDE OPEN. THE PATIENT¿S CGM WAS READING ¿SENSOR FAILED¿, BUT IT WAS NOT SPECIFIED WHEN THE FAILURE OCCURRED SINCE THE PATIENT HAD BEEN SLEEPING. THE PATIENT¿S BG METER READING WAS TESTED AND FOUND TO BE BELOW 20 MG/DL. THE REPORTER TREATED THE PATIENT WITH NASAL GLUCAGON SPRAY AND CALLED 911. ONCE EMERGENCY MEDICAL SERVICES (EMS) ARRIVED, THE PATIENT¿S BG METER READING WAS 51 MG/DL AND HE WAS TREATED WITH AN UNSPECIFIED IV BAG. HE WAS TRANSPORTED TO THE ER. AT THE ER, THE PATIENT¿S BG METER READING WAS 189 MG/DL. THE PATIENT WAS OBSERVED FOR APPROXIMATELY 5 HOURS BEFORE BEING DISCHARGED. THE PATIENT WAS ¿WEAK BUT BETTER¿ AT THE TIME OF REPORT. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. PROBLEM COULD NOT BE CONFIRMED, AND PROBABLE CAUSE CANNOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED.
Report #7 - 3004753838-2025-270755 CRITICAL
View on MAUDE
Date of Event 2025-09-13
Patient Gender Male
Patient Age 83 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). | IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. IN THE MIDDLE OF THE NIGHT THE PATIENT WAS ASLEEP AND THE WIFE REPORTEDLY COULD NOT WAKE THE PATIENT AND NOTED HE WAS UNRESPONSIVE. THE WIFE AND NEIGHBOR TOOK HIM TO HOSPITAL. THERE WERE NO CGM READINGS REPORTED BEFORE HE WAS TAKEN TO HOSPITAL. THE PATIENT WAS HOSPITALIZED FOR COUPLE OF DAYS AND THEY COULD NOT REMEMBER TREATMENT PROVIDED AT THE HOSPITAL. DURING THE EVENT IT WAS NOTED THAT THE PATIENT DID NOT RECEIVE AN ALERT NOTIFICATION (SOUND) ON THE CGM, ALTHOUGH IT WAS NOT REPORTED WHAT THE CGM WAS DISPLAYING WHEN THEY WERE UNRESPONSIVE. AT THE TIME OF THE REPORT, THE PATIENT WAS DOING OKAY. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION AND PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.
Report #8 - 3004753838-2025-269964 CRITICAL
View on MAUDE
Date of Event 2025-09-13
Patient Gender Male
Patient Age 66 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT EXPERIENCED A LOSS OF CONSCIOUSNESS AT APPROXIMATELY 8:00 AM WHILE ATTENDING AN EVENT. AT THE TIME OF THE INCIDENT, THE CGM VALUE WAS NOT DOCUMENTED. HOWEVER, PRIOR TO ARRIVING AT THE EVENT, THE PATIENT¿S CGM WAS READING 256 MG/DL, WHILE THE BG METER SHOWED 125 MG/DL. THE PATIENT WAS USING A TANDEM INSULIN PUMP. EMERGENCY MEDICAL SERVICES (EMS) WERE DISPATCHED. UPON ARRIVAL, EMS RECORDED A BG METER READING IN THE 40S MG/DL, WHILE THE CGM WAS DISPLAYING HIGH MG/DL. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM, WHERE CONSCIOUSNESS WAS REGAINED. TREATMENT INCLUDED AN UNSPECIFIED MEDICATION, JUICE, AND TWO SANDWICHES. THE PATIENT WAS DISCHARGED APPROXIMATELY THREE HOURS LATER WITH A BG METER READING OF 266 MG/DL. AT THE TIME OF THE REPORT, THE PATIENT WAS DESCRIBED AS ¿DOING FINE.¿ NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID WAS TAKEN PRIOR PASSING OUT. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE REPORTED GLUCOSE VALUES FALL WITHIN THE E ZONE OF THE PARKES ERROR GRID WAS TAKEN AT THE HOSPITAL. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4).
Report #9 - 3004753838-2025-273827 CRITICAL
View on MAUDE
Date of Event 2025-09-11
Patient Gender Female
Patient Age 47 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA, DIABETIC KETOACIDOSIS AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN. ON (B)(6) 2025, THE PATIENT WAS FOUND UNCONSCIOUS AND TRANSPORTED TO THE HOSPITAL VIA AMBULANCE. UPON ARRIVAL, A FINGERSTICK BLOOD GLUCOSE TEST SHOWED A CGM READING OF 40 MG/DL, WHILE THE BG READING WAS 570 MG/DL, INDICATING A DISCREPANCY. THE PATIENT WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA) AND ADMITTED TO THE INTENSIVE CARE UNIT (ICU). TREATMENT INCLUDED INSULIN THERAPY. THE PATIENT WAS DISCHARGED THREE DAYS LATER. THERE WAS NO DOCUMENTATION OF ADDITIONAL MEDICAL EVALUATION OR FOLLOW-UP INTERVENTION. AT THE TIME OF REPORTING, THE PATIENT WAS REPORTED TO BE STABLE. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID ON (B)(6) 2025. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID ON (B)(6) 2025. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #10 - 3004753838-2025-273858 CRITICAL
View on MAUDE
Date of Event 2025-09-11
Patient Gender Male
Patient Age 63 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON (B)(6) 2025, THE PATIENT PERFORMED A SOFTWARE UPDATE ON THEIR TANDEM INSULIN PUMP BETWEEN 9:20 AM AND 10:00 AM. LATER THAT DAY, AROUND 1:00¿1:30 PM, THE PATIENT BEGAN EXPERIENCING NAUSEA, WITH A DEXCOM CGM READING OF APPROXIMATELY 150 MG/DL. THE NAUSEA WORSENED, AND BY 2:00 PM, THE PATIENT BECAME VIOLENTLY ILL. AT THAT TIME, THE CGM READING WAS 160 MG/DL, WHILE A FINGERSTICK BLOOD GLUCOSE READING SHOWED 60 MG/DL. AT APPROXIMATELY 3:30 PM, ANOTHER FINGERSTICK WAS PERFORMED, SHOWING A BG READING OF 51 MG/DL, WHILE THE CGM DISPLAYED VALUES BETWEEN 110¿130 MG/DL. THE PATIENT ATTEMPTED TO CONSUME LIQUID GLUCOSE, BUT WAS UNABLE TO RAISE THEIR BLOOD GLUCOSE LEVELS. BY 4:30 PM, THE PATIENT¿S SPOUSE FOUND THE PATIENT SLUMPED OVER AT HIS DESK AND UNRESPONSIVE. SHE HAD ATTEMPTED TO CALL HIM EARLIER BUT RECEIVED NO RESPONSE. THE PATIENT LATER REPORTED BEING UNABLE TO ACTIVATE SIRI DUE TO SLURRED SPEECH. THE INSULIN PUMP WAS REMOVED, AND TRUPLUS LIQUID GLUCOSE SHOTS (15G CARBOHYDRATES PER BOTTLE) WERE ADMINISTERED. BY THE EVENING, THE PATIENT BEGAN TO RECOVER. A POST-TREATMENT FINGERSTICK SHOWED A BG READING OF 60¿65 MG/DL, WHILE THE CGM READ 120 MG/DL. BLOOD GLUCOSE LEVELS GRADUALLY INCREASED AND STABILIZED AROUND 120 MG/DL LATER THAT NIGHT. FOLLOWING THE PUMP UPDATE, IT WAS DISCOVERED THAT THE BASAL RATES HAD DOUBLED UNEXPECTEDLY, A CHANGE THE PATIENT WAS UNAWARE OF WHILE MANAGING THE HYPOGLYCEMIC EPISODE. AT THE TIME OF REPORTING, THE PATIENT WAS STABLE. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR WHEN THE PATIENT BEGAN EXPERIENCING NAUSEA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID WHEN THE NAUSEA WORSENED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C AND D ZONE OF THE PARKES ERROR GRID AT APPROXIMATELY 3:30 PM. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C OF THE PARKES ERROR GRID DURING THE POST-TREATMENT. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #11 - 3004753838-2025-270475 CRITICAL
View on MAUDE
Date of Event 2025-09-11
Patient Gender Male
Patient Age 19 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON (B)(6) 2025, THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS. IT WAS NOT KNOWN WHAT THE CGM OR BLOOD GLUCOSE READING WAS AT THE TIME OF THE ONSET OF SYMPTOMS. AN AMBULANCE WAS CALLED AND WHEN A FINGERSTICK WAS TAKEN BY THE PARAMEDICS THE CGM READING WAS 67 MG/DL, AND THE BLOOD GLUCOSE READING WAS 36 MG/DL. THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS. THE PATIENT STATED THAT THEY HAD BEEN CONFUSED, ¿LOW HANGOVER¿, AND SICK TO THE STOMACH DURING THE EVENT, BUT RECOVERED AT HOME, AND WAS BROUGHT TO THE HOSPITAL. THERE WAS NO INFORMATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION AT THE HOSPITAL. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.
Report #12 - 3004753838-2025-270611 CRITICAL
View on MAUDE
Date of Event 2025-09-11
Patient Gender Male
Patient Age 66 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS WHEN DRIVING THEIR CAR. THE PATIENT DID NOT EXPERIENCE ANY OTHER SYMPTOMS BEFORE LOSING CONSCIOUSNESS. WHEN THE PATIENT REGAINED CONSCIOUSNESS THERE WAS A SHERIFF WHO GAVE HIM SKITTLES AND SUGAR TABLETS. WHEN THE AMBULANCE ARRIVED A FINGERSTICK WAS TAKEN, AND THE CGM READING WOULD HAVE BEEN ¿WAY OFF¿, BUT NO SPECIFIC CGM NOR BLOOD GLUCOSE READING WAS REPORTED. THE PATIENT WAS TREATED WITH INTRAVENOUS GLUCOSE AND WAS BROUGHT TO THE HOSPITAL. NO FURTHER TREATMENT WAS REPORTED TO BE NEEDED AND AFTER 4 HOURS THE PATIENT WAS DISCHARGED. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALLS WITHIN THE B ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #13 - 3004753838-2025-267076 CRITICAL
View on MAUDE
Date of Event 2025-09-10
Patient Gender Female
Patient Age 74 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA AND LOSS OF CONSCIOUSNESS. PLEASE DISREGARD H6 HEALTH EFFECT CLINICAL CODE - 4582 NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AS THIS CODES ARE NOT APPLICABLE FOR THIS REPORT. | IT WAS REPORTED THAT NO READINGS OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. ON THE EVENING OF (B)(6) 2025, THE PATIENT EXPERIENCED A SYNCOPAL EPISODE AFTER HER MOBILE DEVICE STOPPED DISPLAYING ESTIMATED GLUCOSE VALUES (EGVS) FOR OVER THREE HOURS. THIS OCCURRED NINE DAYS AFTER THE SENSOR WAS APPLIED TO HER ABDOMEN. THE PATIENT USES THE INSULET OMNIPOD5 SYSTEM, WHICH WOULD NOT HAVE OPERATED IN MODIFIED CLOSED-LOOP MODE WITHOUT ACTIVE EGV DATA. AT THE TIME OF THE EVENT, THE PATIENT REPORTED FEELING WEAK BEFORE PASSING OUT. SHE WAS NOT RECEIVING GLUCOSE READINGS DUE TO A SENSOR ERROR. THE DURATION OF THE SENSOR ERROR PRIOR TO THE SYNCOPAL EPISODE IS UNKNOWN, AS THE PATIENT COULD NOT RECALL THE TIMELINE. HER HUSBAND CALLED EMERGENCY MEDICAL SERVICES (EMS), WHO PERFORMED A FINGERSTICK TEST SHOWING A BLOOD GLUCOSE LEVEL OF 251 MG/DL. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM. SHE DOES NOT REMEMBER HOW LONG SHE WAS UNCONSCIOUS AND WAS UNSURE WHETHER ANY MEDICATIONS WERE ADMINISTERED DURING HER TREATMENT. THE PATIENT WAS DISCHARGED THE FOLLOWING MORNING BUT REPORTED STILL FEELING UNWELL AT THE TIME OF THE CALL. DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS NOT CONFIRMED VIA DATA. HOWEVER, IT WAS FOUND THAT NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE UNDER AN HOUR OCCURRED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #14 - 3004753838-2025-269242 CRITICAL
View on MAUDE
Date of Event 2025-09-09
Patient Gender Female
Patient Age 20 YR
Device STELO GLUCOSE BIOSENSOR SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED VIA STELOBOT THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE BIOSENSOR WAS INSERTED INTO THE BACK OF THE UPPER ARM ON (B)(6) 2025. PRIOR TO THE EVENT, THE CONSUMER'S CGM READINGS WERE REPORTED AS ¿NORMAL,¿ THOUGH NO SPECIFIC VALUES WERE PROVIDED. ON THE MORNING OF (B)(6) 2025 AT APPROXIMATELY 6:30 AM, THE CONSUMER GOT UP TO TAKE A SHOWER. DURING THIS TIME, HER BLOOD GLUCOSE DROPPED, AND SHE LOST CONSCIOUSNESS. NO SYMPTOMS WERE REPORTED PRIOR TO THE EVENT. AT THE TIME OF THE INCIDENT, THE CGM APP CONTINUED TO DISPLAY ¿NORMAL¿ READINGS. THE PARENT OBSERVED THAT THE CONSUMER WAS UNRESPONSIVE AND ADMINISTERED GLUCOSE TABLETS AND LEMONADE. THE CONSUMER REGAINED CONSCIOUSNESS SHORTLY AFTERWARD AND BEGAN TO FEEL BETTER, THOUGH SHE REMAINED FATIGUED AND STAYED HOME FROM SCHOOL TO REST FOR THE REMAINDER OF THE DAY. NO GLUCOMETER READINGS WERE TAKEN DURING THE EVENT, AND NO ALERTS OR LOW GLUCOSE READINGS WERE VISIBLE IN THE STELO APP AT THE TIME OF THE REPORT. THE PARENT CONFIRMED THAT NO MEDICAL TREATMENT OR INTERVENTION BY A HEALTHCARE PROVIDER WAS SOUGHT. THE CONSUMER WAS NOT HOSPITALIZED AND RECOVERED AT HOME. NO ADDITIONAL EVENT DETAILS WERE AVAILABLE AT THE TIME OF THE REPORT. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #15 - 3004753838-2025-274426 CRITICAL
View on MAUDE
Date of Event 2025-09-08
Patient Gender Female
Patient Age 63 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS AND LOSS OF CONSCIOUSNESS. | THE COMPLAINT STATES THAT "ALERT/NOTIFICATION SETTINGS" WAS REPORTED. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT WOKE UP 6AM AND HER MOBILE DEVICE SHOWED 400 MG/DL. SHE CLAIMED IT WAS 400 MG/DL SINCE 4AM BUT SHE DID NOT GET AN ALERT. SHE DID A BG FS AND HER SUGAR WAS AT 498 MG/DL. SHE USES INSULET OMNIPOD5 IN MODIFIED CLOSED LOOP. SHE WAS UNCONSCIOUS FROM DKA. THE PATIENT THOUGHT CGM SHOULD HAVE ALERTED HER BUT SHE NEVER HEARD AN ALERT THOUGH ALL ALERTS ARE WORKING AND THEY'RE ALL SET. WHEN SHE CAME BACK FROM CONSCIOUSNESS, SHE HAD BLURRED VISION, VOMITING AND COULD NOT TALK STRAIGHT BECAUSE SHE WAS DEHYDRATED. SHE CALLED AN AMBULANCE AFTER GETTING BACK TO HER SENSES AND HER FRIEND CAME OVER. CGM READING AT THE TIME OF EVENT WAS STILL AT 400 MG/DL. IT STAYED AT 400 MG/DL. SHE WAS BROUGHT TO THE HOSPITAL BY PARAMEDICS AND WHILE IN THE AMBULANCE, PARAMEDICS CHECKED HER READING BUT SHE DOESN'T KNOW WHAT IT WAS AS SHE STILL KEPT GOING IN AND OUT OF CONSCIOUSNESS. PARAMEDICS TRIED TO DO AN IV BUT HER VEINS WERE INACCESSIBLE DUE TO DEHYDRATION. IN THE HOSPITAL SHE WAS GIVEN A 10 UNIT PUSH AND WAS PUT ON TO IV INSULIN DRIP AND IV FLUIDS. SHE WAS PLACED IN THE ICU. SHE STAYED IN THE HOSPITAL FROM (B)(6) 2025. BEFORE GETTING DISCHARGED, HER READINGS AT CGM WAS AT 240 MG/DL WHILE FS WERE AT 210 AND 212 MG/DL. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. PROBLEM COULD NOT BE CONFIRMED AND PROBABLE CAUSE CANNOT BE DETERMINED.
Report #16 - 3004753838-2025-266898 CRITICAL
View on MAUDE
Date of Event 2025-09-08
Patient Gender Female
Patient Age 44 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. ACCORDING TO THE PATIENT, ON APPROXIMATELY (B)(6) 2025, THE PATIENT LOST CONSCIOUSNESS WHILE DRIVING AND WAS IN A MOTOR VEHICLE ACCIDENT. A BYSTANDER HELPED THE PATIENT OUT OF THE CAR AND CALLED EMERGENCY SERVICES. AT THE TIME THE PARAMEDICS ARRIVED, THE CGM WAS DISPLAYING A LOW READING (UNSPECIFIED VALUE), BUT A FINGER STICK TEST SHOWED BLOOD GLUCOSE LEVEL OF 20 MG/DL. THE PATIENT WAS UNCONSCIOUS DUE TO HYPOGLYCEMIA, NO PHYSICAL INJURIES WERE REPORTED. THE PARAMEDICS ADMINISTERED GLUCOSE GEL AND APPLE JUICE. SHORTLY AFTER RECEIVING TREATMENT, THE PATIENT REGAINED CONSCIOUSNESS AND WAS ABLE TO CONTINUE ON TO WORK. AT THE TIME OF THE REPORT, THE PATIENT WAS FEELING OKAY. THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #17 - 3004753838-2025-265242 CRITICAL
View on MAUDE
Date of Event 2025-09-08
Patient Gender Female
Patient Age 74 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ACCORDING TO THE PATIENT, ON (B)(6) 2025, THE PATIENT LOST CONSCIOUSNESS. HER DAUGHTER WENT TO HER ROOM AND GAVE HER MEDICINE (UNKNOWN) UNDER HER TONGUE AND ORANGE JUICE. THE PATIENT PROVIDED THE VALUES OF CGM 194MGDL AND BGM OF 70MG/DL BUT DID NOT SPECIFY IF THEY WERE TAKEN BEFORE OR AFTER TREATMENT. THE PATIENT DID NOT GO TO ANY HEALTH CARE FACILITY SINCE SHE WAS SO WEAK, BUT SHE CALLED HER DOCTOR TO REPORT THE INCIDENT. NO OTHER INFORMATION WAS GATHERED ON THE CALL SINCE SHE REFUSED TO PROVIDE MORE DETAILS. AT THE TIME OF THE REPORT, THE PATIENT WAS FEELING OK. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALLS WITHIN THE B ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #18 - 3004753838-2025-275054 CRITICAL
View on MAUDE
Date of Event 2025-09-07
Patient Gender Female
Patient Age 79 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. THE WEARABLE WAS INSERTED INTO THE SKIN. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FAILURE TO ALERT AFTER WHICH THEY EXPERIENCED A HYPOGLYCEMIC EVENT. THE DAY OF THE EVENT THE PATIENT EXPERIENCED FEELING WEAK, HAD PAIN IN BOTH LEGS, AND LOST CONSCIOUSNESS. THE DEXCOM DEVICE WOULD HAVE NOT ALERTED FOR AN ALREADY LOW CGM READING. THE PATIENT WAS FOUND BY THE PATIENT´S SON AT AROUND 05:00PM AND AN AMBULANCE WAS CALLED AND THE PATIENT WAS BROUGHT TO THE HOSPITAL. THE PATIENT REGAINED CONSCIOUSNESS AT THE HOSPITAL THE NEXT DAY AND WAS UNAWARE OF HOW SHE GOT THERE. THE PATIENT ASSUMED THAT SHE RECEIVED INTRAVENOUS TREATMENT BUT COULD NOT CONFIRM ANY DETAILS REGARDING THIS. NO OTHER DETAILS WERE DOCUMENTED AND THE PATIENT DECLINED TO PROVIDE FURTHER INFORMATION. DATA HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. | (B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #19 - 3004753838-2025-270024 CRITICAL
View on MAUDE
Date of Event 2025-09-07
Patient Gender Female
Patient Age 76 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. | IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ACCORDING TO THE PATIENT, ON (B)(6) 2025, THE PATIENT STATED THAT THEIR SENSOR FAILED. NO NEW SENSOR HAD BEEN INSERTED BY THE PATIENT AND COULD NOT SAY HOW LONG SHE HAD NO SENSOR ON AND REPORTED NO CONTINUOUS GLUCOSE MONITOR (CGM) READING OR BLOOD GLUCOSE READINGS. BY SUNDAY MORNING ((B)(6) 2025) WHILE PREPARING TO GO OUT, SHE SUDDENLY PASSED OUT. THE PATIENT FELT NO SYMPTOMS PRIOR TO PASSING OUT. SHE WAS TOLD THAT SOMEONE CALLED THE PARAMEDICS WHO BROKE DOWN HER DOOR AND FOUND HER PASSED OUT. THE PARAMEDICS THEN GAVE HER INTRAVENOUS (IV) GLUCOSE AND SHE SLOWLY REGAINED CONSCIOUSNESS. THE PATIENT WAS IN A STATE OF CONFUSION AND WAS UNABLE TO ANSWER QUESTIONS COHERENTLY. THE PATIENT IS UNABLE TO RECALL IF ANY FINGER STICKS WERE TAKEN. THE PARAMEDICS LEFT WHEN THE PATIENT WAS STABLE AND OBSERVED NO INJURIES. SHE WAS NOT TAKEN TO THE HOSPITAL OR URGENT CARE. THE NEXT MORNING ((B)(6) 2025), THE PATIENT WENT TO SEE HER DOCTOR FOR A FOLLOW-UP CHECKUP, AND SHE THEN PUT ON A NEW G7 WEARABLE. AT THE TIME OF THE CALL, THE PATIENT IS IN GOOD CONDITION, ALTHOUGH HURTING IN THE HIPS. DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS NOT CONFIRMED VIA DATA. HOWEVER, NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE UNDER AN HOUR WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #20 - 3004753838-2025-262553 CRITICAL
View on MAUDE
Date of Event 2025-09-07
Patient Gender Male
Patient Age 33 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. | IT WAS REPORTED THAT AN UNSPECIFIED MALFUNCTION OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 0225. ON (B)(6) 2025, THE PATIENT'S ROOMMATE WHO FOLLOWS THE PATIENT VIA FOLLOW APP NOTICED A LACK OF UPDATES AND SENT A TEXT MESSAGE TO THE PATIENT ASKING IF THE PATIENT HAD RECEIVED ANY ALERTS. THE PATIENT DID NOT RESPOND TO THE ROOMMATE CONTACTED THE PATIENT¿S BROTHER TO CHECK ON HIM. UPON CHECKING, THE BROTHER FOUND THE PATIENT PASSED OUT AND CALLED 911. THE PATIENT COULD NOT RECALL ANYTHING PRIOR TO PASSING OUT, OR ANY SYMPTOMS LEADING UP TO IT. HE ALSO DID NOT RECALL WHAT THE CGM WAS DISPLAYING AT THE TIME OR HOW LONG HE WAS UNCONSCIOUS. THE ONLY THING THE PATIENT REMEMBERS IS THAT PARAMEDICS ADMINISTERED IV DEXTROSE AFTER THEY CHECKED A BLOOD GLUCOSE READING OF 19 MG/DL. THE PATIENT WAS UNSURE WHETHER THE SENSOR FELL OFF OR WAS REMOVED BY THE PARAMEDICS OR HIS BROTHER. HE REGAINED CONSCIOUSNESS AT HOME AND WAS THEN TRANSPORTED TO THE HOSPITAL BY AMBULANCE. AT THE HOSPITAL, HE RECEIVED ANOTHER IV DEXTROSE TREATMENT, SOME FORM OF SUGAR FOR NAUSEA (EXACT TYPE UNKNOWN), AND AN UNSPECIFIED MEDICATION TO HELP WARM HIS BODY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER 10 HOURS. AT THE TIME OF THE REPORT, THE PATIENT WAS FEELING GOOD. DATA HAS BEEN REQUESTED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #21 - MW5176535 CRITICAL
View on MAUDE
Date of Event 2025-09-06
Patient Gender Female
Patient Age 21 YR
Device DEXCOM G6 (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
DEXCOM G6 SENSOR WAS READING MY BLOOD SUGARS WERE SEVERELY LOW WHEN I CHECKED MANUALLY THEY WERE OVER 200 WHICH FOR ME IS VERY HIGH AS I HAVE VERY GOOD CONTROL. MY INSULIN PUMP (OMNIPOD) WAS NOT GIVING ME ANY INSULIN DUE TO THE INACCURATE READINGS FROM MY DEXCOM. I THEN CALLED DEXCOM AND PUT ON A NEW SENSOR THE SAME THING HAPPENED. I HAVE BEEN USING DEXCOM FOR OVER 5YEARS NOW AND THE PAST 2 MONTHS THEY HAVE BEEN VERY INACCURATE. THIS GOES FOR THE OMNIPOD AS WELL. MY OMNIPOD GAVE ME 15 EXTRA UNITS OF INSULIN BY LEAKING. I WAS SO LOW I FAINTED I WAS UNRESPONSIVE FOR 2 MINUTES DRENCHED IN SWEAT. I WAS ALONE IN MY HOUSE AND HAD TO CRAWL TO FIND SUGAR. THESE ISSUES NEED TO BE ADDRESSED. PT CODE:: 1905. DEVICE CODES: 2588, 1506, 1535. REFERENCE REPORT: MW5176534.
Report #22 - 3004753838-2025-265272 CRITICAL
View on MAUDE
Date of Event 2025-09-06
Patient Gender Male
Patient Age 72 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, AT APPROXIMATELY 6:30 PM, THE PATIENT USED A BLOOD GLUCOSE METER (BGM) TO CHECK HIS BG PRIOR TO INSULIN ADMINISTRATION, WHICH SHOWED A VALUE OF 179 MG/DL. THE PATIENT TYPICALLY ADMINISTERS INSULIN MANUALLY AFTER MEALS. HE COULD NOT RECALL THE CGM READING AT THAT TIME. APPROXIMATELY ONE HOUR LATER, THE CGM BEGAN DISPLAYING RISING GLUCOSE VALUES, PROMPTING THE TANDEM PUMP TO DELIVER INSULIN THREE TIMES, TOTALING 12 UNITS. NO MANUAL BG COMPARISON WAS PERFORMED DURING THIS PERIOD. THE PATIENT BEGAN FEELING WEAK AND WENT TO BED AROUND 10:00 PM, WITHOUT CHECKING EITHER BGM OR CGM VALUES. AT APPROXIMATELY 11:00 PM, THE PATIENT¿S WIFE FOUND HIM UNRESPONSIVE AND CALLED 911. THE PATIENT REMAINED UNCONSCIOUS WHEN PARAMEDICS ARRIVED. IT IS UNKNOWN WHETHER ANY MEDICATION WAS ADMINISTERED OR BG READINGS WERE TAKEN PRIOR TO TRANSPORT. UPON ARRIVAL AT THE EMERGENCY ROOM (ER), THE PATIENT REGAINED CONSCIOUSNESS AND WAS INFORMED THAT HIS BG LEVEL WAS 43 MG/DL. THE CGM VALUE AT THAT TIME WAS NOT CHECKED. THE PATIENT DOES NOT RECALL ANY SPECIFIC TREATMENT OR PROCEDURES PERFORMED WHILE IN THE ER. BEFORE DISCHARGE AT 2:45 AM ON (B)(6) 2025, A FINGERSTICK (FS) TEST WAS PERFORMED, BUT THE EXACT VALUE WAS NOT DISCLOSED TO THE PATIENT, ONLY THAT IT WAS ¿OK.¿ THE PATIENT DID NOT CHECK HIS CGM READINGS DURING THIS TIME. AT THE TIME OF THE FOLLOW-UP CALL, THE PATIENT WAS STILL WEARING THE CGM DEVICE, WHICH WAS DISPLAYING A VALUE OF 179 MG/DL, WHILE THE BGM SHOWED 138 MG/DL. THE PATIENT REPORTED FEELING FINE UPON LEAVING THE EMERGENCY ROOM. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR ON (B)(6) 2025. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID ON (B)(6) 2025. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #23 - 3004753838-2025-259093 CRITICAL
View on MAUDE
Date of Event 2025-09-06
Patient Gender Male
Patient Age 49 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT A SIGNAL LOSS OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIGNAL LOSS WHILE THEY WERE EXPERIENCING A HYPOGLYCEMIC EVENT. THE PATIENT IS LEGALLY BLIND AND THE APP IS SET UP TO TELL THE PATIENT WHAT THE CGM READINGS ARE EVERY 15 MINUTES. ON THE DAY OF THE EVENT THE CGM READING WAS 3.3 MMOL/L AND DROPPING. THE PATIENT FELT LIGHTHEADED AT THAT TIME, AND ATE CARBOHYDRATES SUCH AS BUTTER TART. THE CGM SHOWED A SIGNAL LOSS AFTER THIS, AND AN UNKNOWN TIME AFTER THIS, THE PATIENT LOST CONSCIOUSNESS. THE WIFE CAME HOME AN HOUR LATER, FOUND THE PATIENT UNCONSCIOUS, AND CALLED THE PARAMEDICS. THE PATIENT WAS BROUGHT TO THE HOSPITAL, WHERE THEY REGAINED CONSCIOUSNESS. THE PATIENT COULD NOT REMEMBER SPECIFIC TREATMENT, BUT ONCE A FINGERSTICK WAS TAKEN THE BLOOD GLUCOSE READING HAD GONE UP TO 7.0 MMOL/L. THE PATIENT STAYED IN THE HOSPITAL FOR 1 NIGHT AND WAS DISCHARGED THE DAY AFTER THE EVENT. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. DATA HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #24 - 3004753838-2025-272384 CRITICAL
View on MAUDE
Date of Event 2025-09-05
Patient Gender Female
Patient Age 18 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. THE DATE OF THE EVENT IS AN APPROXIMATION. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED INACCURATE CGM VALUES. BEFORE GOING TO SLEEP THE CGM READING WAS 235 MG/DL, AND THE BLOOD GLUCOSE READING WAS 170 MG/DL. THE PATIENT WAS UNABLE TO CALIBRATE. THE NEXT MORNING THE PATIENT WAS FOUND UNCONSCIOUS BY A ROOMMATE, AND THE PATIENT WOULD HAVE HAD A DIABETIC SEIZURE. AN AMBULANCE WAS CALLED AND THE PATIENT WAS BROUGHT TO THE HOSPITAL. THE PATIENT WAS TREATED WITH INTRAVENOUS DEXTROSE D10 AND D50. NO FURTHER TREATMENT WAS REPORTED TO BE NEEDED. IT WAS UNKNOWN HOW MUCH TIME THE PATIENT SPENT AT THE HOSPITAL. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALLS WITHIN THE B ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #25 - 3004753838-2025-270276 CRITICAL
View on MAUDE
Date of Event 2025-09-05
Patient Gender Male
Patient Age 69 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6)2025. ON (B)(6)2025 AT AROUND 12:30 PM, THE PATIENT WAS AT HOME AND HIS SPOUSE TRIED TO CALL HIM; HOWEVER, THE PATIENT WAS NOT ANSWERING. HIS WIFE LOOKED AT THEIR CAMERA AT HOME AND SHE SAW THAT THE PATIENT PASSED OUT. SHE WENT HOME AND FOUND THE PATIENT ON THE FLOOR, UNRESPONSIVE AND DROOLING. SHE DOE NOT KNOW HOW LONG THE PATIENT WAS UNCONSCIOUS BUT SHE THINKS IT WAS MORE THAN AN HOUR. SHE CALLED 911 AND DID NOT CHECK THE CGM READINGS OR THE FINGER PRICK. SHE STATED THAT ALL SHE KNOWS IS THAT THE CGM DID NOT ALERT THEM THAT IT WAS LOW. SHE WAS NOT SURE WHETHER IT WAS READING INACCURATELY OR IF IT WAS READING RIGHT AND JUST DID NOT ALERT AT THE TIME. WHEN EMERGENCY MEDICAL SERVICES (EMS) ARRIVED, THEY PRICKED HIS FINGER AND THE READING WAS 26 MG/DL. THEY ADMINISTERED GLUCAGON SHOT (INJECTION) AND WAITED FOR HIM TO REGAIN CONSCIOUSNESS. SHORTLY AFTER, THE PATIENT WOKE UP AND EMS ADVISED HIM TO GO TO THE HOSPITAL BUT THE PATIENT DECLINED. BEFORE THE EMS LEFT, THE PATIENT'S BG READING WAS 240 MG/DL. AT THE TIME OF THE REPORT, THE PATIENT WAS FEELING BETTER. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.
Report #26 - 3004753838-2025-267908 CRITICAL
View on MAUDE
Date of Event 2025-09-05
Patient Gender Female
Patient Age 39 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. THIS REPORT IS 1 OF 2 ALLEGATIONS OF INSUFFICIENT INFORMATION FOR COMPLAINT CLASSIFICATION THAT HAD SIMILAR EVENT DETAILS. RELATED RECORDS: (B)(4), (B)(4). | IT WAS REPORTED THAT AN UNSPECIFIED MALFUNCTION/ISSUE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT'S RECEIVER INDICATED THAT THE BATTERY WAS LOW. THIS REPORT IS 1 OF 2 ALLEGATIONS OF INSUFFICIENT INFORMATION FOR COMPLAINT CLASSIFICATION THAT HAD SIMILAR EVENT DETAILS. THE PATIENT IMMEDIATELY CHARGED IT AND WHEN SHE TURNED IT BACK ON THE ALERT THAT CAME UP ON THE RECEIVER WAS "REPLACE SENSOR". SHE SUDDENLY BLACKED OUT AND LOST CONSCIOUSNESS AND IT HAPPENED AGAIN. ON (B)(6) 2025, THE PATIENT WAS AT HOME AFTER DISCHARGE FROM AN IDENTICAL EVENT. HER RECEIVER INDICATED THAT THE BATTERY WAS LOW. SHE IMMEDIATELY CHARGED IT AND WHEN SHE TURNED IT BACK ON THE ALERT ON HER RECEIVER WAS "REPLACE SENSOR". SHE IMMEDIATELY CHECKED HER BLOOD GLUCOSE ON THE BG METER AND HER BG READING WAS AT 150 MG/DL BUT SUDDENLY SHE FAINTED AND LOST CONSCIOUSNESS. WHEN SHE REGAINED CONSCIOUSNESS, SHE IMMEDIATELY CALLED THE EMERGENCY MEDICAL TEAM (EMT) AND THEY ARRIVED SHORTLY AFTER. SHE COULD NOT REMEMBER WHAT HER ACTUAL BLOOD GLUCOSE WAS WHEN THE EMT ARRIVED AT THEIR HOUSE. THE MEDICATION GIVEN TO HER WAS GLUCOSE LIQUID IV. WHEN THEY ARRIVED AT THE HOSPITAL, SHE COULD NOT REMEMBER WHAT HER ACTUAL BLOOD GLUCOSE WAS BECAUSE SHE WAS STILL UNCONSCIOUS. SHE WAS CONTINUOUSLY GIVEN GLUCOSE LIQUID IV AND WAS IN THE HOSPITAL FOR 4 DAYS AND HAS NOT BEEN DISCHARGED FROM THE HOSPITAL TO DATE. SHE CONFIRMED THAT SHE WAS FEELING BETTER DURING THE CALL. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #27 - 3004753838-2025-263154 CRITICAL
View on MAUDE
Date of Event 2025-09-05
Patient Gender Male
Patient Age 69 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT'S DAUGHTER HELPED THE PATIENT TO CALIBRATE. THE PATIENT USES TANDEM TSLIM IN MODIFIED CLOSED LOOP. THE BG WAS 65 MG/DL WHILE THE CGM WAS 75 MG/DL. NO MENTION OF THE HYPOGLYCEMIA WAS TREATED. SOMETIME, THE PATIENT BECAME UNRESPONSIVE ACCORDING TO HIS WIFE SO THE WIFE CALLED THE PARAMEDICS RIGHT AWAY. PARAMEDICS CAME AND CHECKED THE BLOOD SUGAR AT 31 MGDL AND CGM WAS 70 MGDL. THEY THEN GAVE GLUCOSE D50. PARAMEDICS WAITED UNTIL HE WOKE UP AND CALIBRATED AGAIN. HIS BLOOD SUGAR LEVEL BGM- 90 MGDL AND CGM- 60 MDGL. HE WASN'T TAKEN TO THE HOSPITAL. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE A ZONE OF THE PARKES ERROR GRID. WHEN THE PARAMEDICS CAME, THE REPORTED GLUCOSE VALUES FALL WITHIN THE A ZONE OF THE PARKES ERROR GRID. ONCE THE PATIENT WOKE UP, THE REPORTED GLUCOSE VALUES FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALLS WITHIN THE B ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #28 - 3004753838-2025-261618 CRITICAL
View on MAUDE
Date of Event 2025-09-05
Patient Gender Male
Patient Age 51 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE OCCURRED. THE WEARABLE IS INSERTED INTO THE ARM ON (B)(6) 2025. ON 09/05/2025, IT WAS REPORTED THAT THE PATIENT¿S WIFE USES THE ILET SHARER APP FOR THE PATIENT¿S BETABIONICS ILET INSULIN PUMP AND SAW THAT HIS BG LEVEL WAS ¿CRASHING¿ (NO SPECIFIC VALUE WAS REPORTED). THE PATIENT¿S WIFE CALLED THE PATIENT 13 TIMES AND THE PATIENT WAS NOT ANSWERING. IT WAS ALSO NOTED THAT THE PATIENT¿S WIFE CALLED THE PATIENT¿S DOCTOR ON HER WAT HOME. ONCE AT THE HOUSE, THE PATIENT WAS UNRESPONSIVE. HIS BG METER READING WAS 49 MG/DL AND THE CGM WAS PROVIDING A ¿BRIEF SENSOR ISSUE¿ ERROR. IT WAS NOT SPECIFIED HOW LONG THE CGM WAS IN THIS ERROR STATE, AND SINCE THE PATIENT HAD BEEN SLEEPING, HE COULD NOT PROVIDE ANY FURTHER DETAILS. THE PATIENT¿S WIFE WOKE THE PATIENT UP AND TREATED HIM WITH CARAMEL CHOCOLATES AND MARSHMALLOW SMORES. THE PATIENT DID NOT SEEK ANY ASSISTANCE FROM A HIGHER LEVEL OF CARE. AT THE TIME OF REPORT, THE PATIENT WAS STABLE AND HIS BG METER READING WAS 158 MG/DL. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION AND PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #29 - 3004753838-2025-265050 CRITICAL
View on MAUDE
Date of Event 2025-09-04
Patient Gender Male
Patient Age 66 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. H6 CODES: HEALTH EFFECT - CLINICAL CODE PROBLEM CODE: E0207 DELIRIUM/ CODE NOT AVAILABLE H6 CODES: HEALTH EFFECT - CLINICAL CODE PROBLEM CODE: CORRECTION TO DISREGARD 4581 APPROPRIATE TERM/CODE NOT AVAILABLE. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT¿S MOBILE DEVICE DISPLAYED AN ESTIMATED GLUCOSE VALUE (EGV) OF 400 MG/DL ON THE SAME DAY THE SENSOR WAS INSERTED INTO THE ARM. THE PATIENT DID NOT PERFORM A BG CHECK BUT ADMINISTERED INSULIN BASED ON THE CGM READING. LATER THAT DAY, THE PATIENT BECAME HYPERTENSIVE AND EXHIBITED SYMPTOMS INCLUDING AGITATION, HALLUCINATIONS, MOBILITY ISSUES, AND INTERMITTENT LOSS OF CONSCIOUSNESS. THE PATIENT¿S DAUGHTER, WHO WAS ATTENDING TO HIM, WAS UNABLE TO COMPARE THE CGM AND BGM READINGS AT THAT TIME. EMERGENCY MEDICAL SERVICES WERE CALLED, AND UPON ARRIVAL, MEDICS NOTED THE EGV WAS 198 MG/DL, WHILE THE BGM READING WAS 36 MG/DL. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL, AND THE SENSOR WAS REMOVED. GLUCOSE WAS ADMINISTERED VIA IV. DURING OBSERVATION, THE PATIENT¿S BGM ROSE TO 254 MG/DL. THE PATIENT WAS DISCHARGED ON (B)(6) 2025, AT 2:15 PM, WITH A BGM OF 216 MG/DL. THERE WAS NO DOCUMENTATION OF TREATMENT FOR REBOUND HYPERGLYCEMIA. AT THE TIME OF THE REPORT, THE PATIENT WAS FINE. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR PRIOR TO EXHIBITED SYMPTOMS. THE REPORTED GLUCOSE VALUES FALL WITHIN THE E ZONE OF THE PARKES ERROR GRID UPON EMT ARRIVAL. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #30 - 3004753838-2025-265319 CRITICAL
View on MAUDE
Date of Event 2025-09-04
Patient Gender N/A
Patient Age N/A
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, AT APPROXIMATELY 3:00 PM, THE PATIENT WAS FOUND UNCONSCIOUS IN HER CAR ON THE SAME DAY THE CGM SENSOR WAS INSERTED INTO HER ARM. A POLICE OFFICER ON THE SCENE CALLED 911. THE PATIENT HAS NO RECOLLECTION OF WHETHER A MANUAL BG READING WAS TAKEN OR IF ANY TREATMENT WAS ADMINISTERED IN THE AMBULANCE, AS SHE REMAINED UNCONSCIOUS DURING TRANSPORT. SHE ALSO COULD NOT RECALL WHETHER HER CGM RECEIVER ALERTED HER PRIOR TO THE EVENT. THE PATIENT ARRIVED AT THE EMERGENCY ROOM (ER) AROUND 5:00 PM AND WAS TREATED WITH IV SUGAR. SHE WAS GIVEN FOOD PRIOR TO BG TESTING, WHICH SHOWED A VALUE OF 114 MG/DL. THE CGM VALUE WAS NOT CHECKED AT THAT TIME BECAUSE THE RECEIVER WAS STILL IN HER CAR. WHEN THE PATIENT¿S DAUGHTER ARRIVED AT THE ER WITH THE RECEIVER, IT CONNECTED TO THE DEXCOM DEVICE AND DISPLAYED A READING OF 223 MG/DL. FIVE MINUTES LATER, THE CGM READING INCREASED TO 257 MG/DL, AND THEN TO 293 MG/DL AFTER ANOTHER FIVE MINUTES. A MANUAL BG READING TAKEN DURING THIS TIME SHOWED 121 MG/DL. THE PATIENT WAS DISCHARGED AROUND 9:00 PM THE SAME DAY. NO ADDITIONAL MEDICATION OR PRESCRIPTIONS WERE PROVIDED. AT THE TIME OF THE REPORT, THE PATIENT WAS OKAY. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR WHEN THE PATIENT WAS TREATED WITH IV SUGAR. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #31 - 3004753838-2025-261645 CRITICAL
View on MAUDE
Date of Event 2025-09-04
Patient Gender Female
Patient Age 53 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT NO READINGS WERE REPORTED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT REPORTED NOT RECEIVING ANY GLUCOSE READINGS FOR A DURATION OF 1 TO 3 HOURS ON EITHER THE RECEIVER OR MOBILE DEVICE. THE PATIENT USES A TANDEM T: SLIM INSULIN PUMP, WHICH WOULD NOT HAVE OPERATED IN MODIFIED CLOSED-LOOP MODE WITHOUT SENSOR READINGS. DURING THIS TIME, THE PATIENT FELT WELL AND WENT TO SLEEP. SHE BECAME UNCONSCIOUS AND WAS UNABLE TO RECALL THE EVENTS THAT FOLLOWED, INCLUDING WHETHER HOSPITALIZATION OCCURRED. UPON EVALUATION BY PARAMEDICS, THE PATIENT¿S BLOOD GLUCOSE LEVEL WAS MEASURED AT 22 MG/DL OR 25 MG/DL. DOCUMENTATION DID NOT INCLUDE CONFIRMATION OF REVERSAL OF HYPOGLYCEMIC SHOCK. NO ADDITIONAL DETAILS WERE PROVIDED, AND MULTIPLE DILIGENT ATTEMPTS TO CONTACT THE REPORTER FOR FURTHER INFORMATION WERE UNSUCCESSFUL. DATA WAS PROVIDED FOR INVESTIGATION. THE PROBLEM OF NO READINGS WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE SENSOR NOISE. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #32 - 3004753838-2025-260055 CRITICAL
View on MAUDE
Date of Event 2025-09-04
Patient Gender Male
Patient Age 25 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON THE EVENING OF (B)(6) 2025, THE CGM WAS 400 MG/DL AND THE INSULIN PUMP ADMINISTERED A BASAL INSULIN DOSE OF APPROXIMATELY (B)(4) UNITS. ALTHOUGH THE BG ON THE DEVICE WAS SHOWING HIGH, THE PATIENT STATED THAT THEIR BG WAS CRITICALLY LOW AROUND 50 MG/DL. IT IS NOT KNOWN IF THE PATIENT CHECKED A BG OR IF THIS WAS THEIR ESTIMATED BG SINCE HE MENTIONED HE DID NOT HAVE ANY TEST STRIPS TO VERY A MANUAL BG FINGER STICK. THE PATIENT WAS FOUND UNCONSCIOUS BY HIS GIRLFRIEND. SHE TOOK HIM TO THE EMERGENCY ROOM. UPON ARRIVAL, A BG WAS CHECKED AND IT WAS 37 MG/DL WHILE THE CGM WAS 300 MG/DL. THE PATIENT WAS TREATED WITH GLUCAGON AND IV SUGAR WATER. THE PATIENT WENT HOME THE FOLLOWING DAY AT 3:00AM WITH A BG OF 110 MG/DL. IT WAS ALSO REPORTED THAT THE CGM WAS DISPLAYING "HIGH" WITH 2 ARROWS UP AND THE BG WAS 250 MG/DL. AT THE TIME OF THE REPORT, THE PATIENT WAS DOING FINE. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.
Report #33 - 3004753838-2025-260539 CRITICAL
View on MAUDE
Date of Event 2025-09-04
Patient Gender Female
Patient Age 67 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. H6 CODES: HEALTH EFFECT - CLINICAL CODE PROBLEM CODE: E2301 ALTERATION IN BODY TEMPERATURE / CODE NOT AVAILABLE H6 CODES: HEALTH EFFECT - CLINICAL CODE PROBLEM CODE : CORRECTION TO DISREGARD 4581 APPROPRIATE TERM/CODE NOT AVAILABLE. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT EXPERIENCED A SUDDEN LOSS OF CONSCIOUSNESS AND WAS REPORTED TO BE COLD TO THE TOUCH. EMERGENCY SERVICES WERE CONTACTED BY THE PATIENT¿S FIANCÉ, AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. THE PATIENT WAS UNABLE TO CONFIRM THE DURATION OF UNCONSCIOUSNESS. UPON ARRIVAL AT THE HOSPITAL, A FINGERSTICK BLOOD GLUCOSE TEST WAS PERFORMED. AT THAT TIME, THE CGM READING WAS 104 MG/DL, WHILE THE BLOOD GLUCOSE METER READING WAS 74 MG/DL. ALTHOUGH IT IS NOT DOCUMENTED, IT IS PRESUMED THAT SOME FORM OF TREATMENT MAY HAVE ALREADY BEEN ADMINISTERED PRIOR TO THESE READINGS. AT THE HOSPITAL, THE PATIENT WAS TREATED WITH PUDDING, CRANBERRY JUICE, AND A TURKEY SANDWICH. A SECOND FINGERSTICK TEST SHOWED A CGM READING OF 98 MG/DL AND A BLOOD GLUCOSE READING OF 104 MG/DL. NO FURTHER TREATMENT WAS REPORTED AS NECESSARY. AT THE TIME OF THE REPORT, THE PATIENT WAS IMPROVING AND GETTING BETTER. THE DURATION OF THE HOSPITAL STAY IS UNKNOWN, AND THERE IS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION. NO ADDITIONAL DETAILS WERE PROVIDED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B AND A ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALLS WITHIN THE B ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #34 - 3004753838-2025-260830 CRITICAL
View on MAUDE
Date of Event 2025-09-04
Patient Gender Male
Patient Age 61 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT REPORTED EXPERIENCING A HYPOGLYCEMIC EVENT WHILE WORKING ON HIS CAR. HE LOST CONSCIOUSNESS AND LATER REGAINED AWARENESS ON HIS OWN, NOTING THAT HE WAS SWEATY UPON WAKING. THE PATIENT WAS UNSURE HOW LONG HE HAD BEEN UNCONSCIOUS. AT THE TIME OF THE EVENT, THE PATIENT¿S CGM WAS IN A SIGNAL LOSS STATE, WHICH PREVENTED HIM FROM RECEIVING ALERTS ABOUT HIS HYPOGLYCEMIA. NO BLOOD GLUCOSE METER READINGS WERE PROVIDED. THE PATIENT SELF-TREATED BY CONSUMING ¿JUNK FOOD¿ AND DID NOT SEEK MEDICAL ATTENTION OR ASSISTANCE FROM A HIGHER LEVEL OF CARE. AT THE TIME OF THE REPORT, THE PATIENT STATED THAT HIS BLOOD GLUCOSE LEVELS HAD STABILIZED. DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS CONFIRMED VIA DATA AS A SIGNAL LOSS EQUAL TO OR UNDER ONE HOUR. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #35 - 3004753838-2025-267912 CRITICAL
View on MAUDE
Date of Event 2025-09-03
Patient Gender Female
Patient Age 39 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. THIS REPORT IS 2 OF 2 ALLEGATIONS OF INSUFFICIENT INFORMATION FOR COMPLAINT CLASSIFICATION THAT HAD SIMILAR EVENT DETAILS. RELATED RECORDS: (B)(4). | IT WAS REPORTED AN UNSPECIFIED MALFUNCTION/ISSUE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT'S RECEIVER INDICATED THAT THE BATTERY WAS LOW. THIS REPORT IS 2 OF 2 ALLEGATIONS OF INSUFFICIENT INFORMATION FOR COMPLAINT CLASSIFICATION THAT HAD SIMILAR EVENT DETAILS. SHE IMMEDIATELY CHARGED IT AND WHEN SHE RETURNED, THE ALERT THAT APPEARED ON HER RECEIVER WAS "REPLACE SENSOR". SHE SUDDENLY PASSED OUT AND BECAME UNCONSCIOUS. WHEN SHE REGAINED CONSCIOUSNESS SHE IMMEDIATELY CALLED THE EMERGENCY MEDICAL TEAM (EMT) AND THEY ARRIVED SHORTLY AFTER. SHE DOES NOT REMEMBER WHAT HER ACTUAL BLOOD GLUCOSE WAS CHECKED WHEN THE EMT ARRIVED AT THEIR HOUSE. THE MEDICATION GIVEN TO HER WAS GLUCOSE LIQUID IV. WHEN THEY ARRIVED AT THE HOSPITAL SHE DOES NOT REMEMBER WHAT HER ACTUAL BLOOD GLUCOSE WAS BECAUSE HE WAS STILL UNCONSCIOUS. SHE WAS CONTINUOUSLY GIVEN LIQUID IV. PATIENT STAYED 1 DAY IN THE HOSPITAL. SHE CONFIRMED SHE IS FEELING WELL DURING THE CALL. DURING THE CALL SHE WAS IN THE HOSPITAL AGAIN FOR AN IDENTICAL EPISODE THAT HAPPENED 2 DAYS LATER. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #36 - 3004753838-2025-259847 CRITICAL
View on MAUDE
Date of Event 2025-09-03
Patient Gender Female
Patient Age 66 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. | IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT WAS WITH HER FRIEND, SLEEPING. THE PATIENT WAS SWEATING AND INCOHERENT AS HER FRIEND TRIED TO WAKE HER UP (NO LOSS OF CONSCIOUSNESS CONFIRMED). HER FRIEND CALLED 911 AT 5:00 AM. THE SENSOR FAILED. THE PARAMEDICS ARRIVED AND THE BGM WAS 40 MG/DL. THEY TREATED THE PATIENT WITH JUICE, A BANANA, AND BREAD WITH PEANUT BUTTER, AND STAYED WITH HER FOR AN HOUR UNTIL HER GLUCOSE WENT UP TO NORMAL. THERE WAS NO INJECTION ADMINISTERED, BUT SOMETHING WAS PUT ON HER MOUTH THAT PARAMEDICS ¿ALWAYS CARRY¿. THE PATIENT WAS BROUGHT TO THE HOSPITAL AS THE BG READING STAYED AT 40 MG/DL. THE PATIENT ARRIVED AT THE HOSPITAL AND "COULDN'T GET HER TEMPERATURE", SO THEY BROUGHT A BIG PLASTIC BLANKET THING FILLED WITH WARM AIR AND FINALLY GOT A TEMPERATURE READING. SHE WASN'T ABLE TO VERIFY THE BG READING WHEN SHE GOT TO THE EMERGENCY ROOM, NO TREATMENT OR MEDICATION. THEY ONLY TOOK A SAMPLE OF BLOOD AND SAID EVERYTHING WENT BACK TO NORMAL, EXCEPT THE KIDNEY FUNCTION WAS A LITTLE BIT LOW, WHICH WAS WHY NO MEDICATION WAS GIVEN. THE DOCTOR'S DIAGNOSIS WAS HYPOGLYCEMIA. THE PATIENT STAYED AT LEAST 5 HOURS AND GOT RELEASED WITH A BG READING OF 172 MG/DL. AT THE TIME OF THE REPORT THE PATIENT WAS FINE. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. PROBLEM COULD NOT BE CONFIRMED AND PROBABLE CAUSE CANNOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #37 - 3004753838-2025-258722 CRITICAL
View on MAUDE
Date of Event 2025-09-03
Patient Gender Female
Patient Age 66 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, 10:00 PM, AFTER INSERTING A NEW SENSOR, THE PATIENT EXPERIENCED A FALSE LOW READING FROM HER CGM. THE DEVICE DISPLAYED A "LOW" GLUCOSE ALERT, WHILE A MANUAL BLOOD GLUCOSE CHECK SHOWED 154 MG/DL. THE PATIENT ATTEMPTED TO CALIBRATE THE SENSOR BUT RECEIVED A MESSAGE TO WAIT 15 MINUTES DUE TO A CALIBRATION ERROR. AFTER WAITING, THE SENSOR THEN DISPLAYED AN ADDITIONAL ERROR MESSAGE INSTRUCTING HER TO WAIT 3 HOURS. THE PATIENT WAITED BUT EVENTUALLY FELL ASLEEP BEFORE THE SENSOR COULD BE PROPERLY CALIBRATED. AT APPROXIMATELY 12:45 AM ON 09/03/2025, THE PATIENT¿S INSULIN PUMP ISSUED AN ALERT INDICATING A SENSOR FAILURE. THE PATIENT WAS ASLEEP AT THE TIME AND DID NOT REPLACE THE SENSOR, REMAINING UNAWARE OF THE MALFUNCTION. AROUND 4:00 AM, A FRIEND ENTERED THE LIVING ROOM TO PERFORM BREATHING EXERCISES AND FOUND THE PATIENT SITTING UPRIGHT ON THE COUCH, UNRESPONSIVE, AND SWEATING PROFUSELY. CONCERNED BY HER CONDITION, THE FRIEND IMMEDIATELY CALLED 911. PARAMEDICS ARRIVED SHORTLY AFTER AND STAYED FOR ABOUT ONE HOUR. THEY ASSESSED THE PATIENT¿S BLOOD GLUCOSE LEVEL, WHICH WAS CRITICALLY LOW AT 40 MG/DL. ALTHOUGH NO MEDICATION WAS ADMINISTERED, THE PATIENT WAS GIVEN FOOD AND FLUIDS SUCH AS JUICE. DUE TO THE PERSISTENT HYPOGLYCEMIA AND THE CONTINUED CGM FAILURE, PARAMEDICS DETERMINED IT WAS UNSAFE TO LEAVE THE PATIENT AT HOME AND TRANSPORTED HER TO THE EMERGENCY ROOM (ER). THE PATIENT REPORTED BEING UNAWARE OF THE TIME FROM THE ARRIVAL OF THE PARAMEDICS UNTIL SHE REACHED THE ER, SUGGESTING A POSSIBLE ALTERED STATE OF CONSCIOUSNESS DURING THAT PERIOD. UPON ARRIVAL AT THE ER, THE DEXCOM SENSOR WAS REMOVED. THE PATIENT¿S BLOOD GLUCOSE REMAINED AT 40 MG/DL, AND STAFF ATTEMPTED TO MEASURE HER BODY TEMPERATURE, WHICH WAS INITIALLY UNSUCCESSFUL DUE TO WET CLOTHING AND SIGNS OF HYPOTHERMIA. NURSES USED A WARMING DEVICE CONNECTED TO HOT AIR TO STABILIZE HER TEMPERATURE. ONCE HER TEMPERATURE WAS SUCCESSFULLY RECORDED, BLOOD WORK WAS PERFORMED. HER GLUCOSE LEVEL HAD RISEN TO 197 MG/DL, INDICATING STABILIZATION. NO MEDICATIONS WERE ADMINISTERED AT THE ER. THE PATIENT WAS DISCHARGED BETWEEN 12:30 PM AND 1:00 PM. AT THE TIME OF THE REPORT, THE PATIENT WAS STABLE AND DOING WELL. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. PROBLEM COULD NOT BE CONFIRMED AND PROBABLE CAUSE CANNOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #38 - 3004753838-2025-260446 CRITICAL
View on MAUDE
Date of Event 2025-09-02
Patient Gender Female
Patient Age 69 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIC SHOCK AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ABDOMEN, WHICH IS OFF-LABEL USAGE OF THE DEVICE, ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT REPORTED HER CGM WAS READING 400 MG/DL WHICH LED HER TO SELF-TREAT WITH INSULIN BEFORE GOING TO SLEEP. THE PATIENT REPORTED EXPERIENCING LOSS OF CONSCIOUSNESS AND REGAINED CONSCIOUSNESS WHILE IN AN AMBULANCE. THE PATIENT COULD NOT RECALL WHO CALLED THE PARAMEDICS. WHILE BEING TRANSPORTED TO THE HOSPITAL, A FINGERSTICK WAS TAKEN BY THE PARAMEDICS WHICH READ 29 MG/DL. THE PATIENT COULD NOT RECALL THE TREATMENT USED TO RAISE HER BLOOD GLUCOSE LEVELS. NO FURTHER TREATMENT WAS REPORTED TO BE NEEDED AND AFTER 6 HOURS THE PATIENT WAS DISCHARGED. THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED.THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALLS WITHIN THE B ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #39 - 3004753838-2025-257203 CRITICAL
View on MAUDE
Date of Event 2025-09-02
Patient Gender Female
Patient Age 35 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. H6 CODES: HEALTH EFFECT - CLINICAL CODE PROBLEM CODE: E0135 TASTE DISORDER / CODE NOT AVAILABLE H6 CODES: HEALTH EFFECT - CLINICAL CODE PROBLEM CODE : CORRECTION TO DISREGARD 4581 APPROPRIATE TERM/CODE NOT AVAILABLE. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, A PATIENT BEGAN FEELING UNWELL SEVEN DAYS AFTER APPLYING A CGM SENSOR TO HER ARM. SHE REPORTED SYMPTOMS INCLUDING A METALLIC TASTE IN HER MOUTH, WEAKNESS, AND SHAKINESS. AT THE TIME, SHE DID NOT PERFORM A BLOOD GLUCOSE METER (BGM) TEST TO COMPARE WITH HER CGM READINGS. THE PATIENT USES A TANDEM T:SLIM INSULIN PUMP IN A MODIFIED CLOSED-LOOP SYSTEM. SHORTLY AFTER THE SYMPTOMS, THE PATIENT LOST CONSCIOUSNESS. SHE WAS UNABLE TO ESTIMATE THE DURATION OF UNCONSCIOUSNESS. UPON REGAINING CONSCIOUSNESS, HER HUSBAND ADMINISTERED GLUCAGON AT HOME. DESPITE THIS INTERVENTION, THE PATIENT CONTINUED TO FEEL SYMPTOMATIC OF HYPOGLYCEMIA. A BGM TEST WAS THEN PERFORMED, SHOWING A BLOOD GLUCOSE LEVEL OF 100 MG/DL, WHILE THE DEXCOM CGM WAS DISPLAYING A READING OF 300 MG/DL. THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION FOLLOWING THE EVENT. AT THE TIME OF THE REPORT, THE PATIENT WAS REPORTED TO BE DOING FINE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR PRIOR TO THE PATIENT LOSING CONSCIOUSNESS. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #40 - 3004753838-2025-275392 CRITICAL
View on MAUDE
Date of Event 2025-09-01
Patient Gender Female
Patient Age NA
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE THIGH, WHICH IS OFF-LABEL USAGE OF THE DEVICE. THE DATE OF EVENT IS AN APPROXIMATION. ACCORDING TO AN INVESTIGATIVE REPORT PUBLISHED ONLINE BY HUNTERBROOK MEDIA, A PARENT ALLEGED THAT THE DEXCOM G7 DEVICE MISREAD THEIR DAUGHTER¿S GLUCOSE LEVELS BY SEVERAL HUNDRED POINTS ON OR AROUND (B)(6) 2025. THIS DISCREPANCY REPORTEDLY LED TO A LIFE-THREATENING COMPLICATION, RESULTING IN THE CHILD BEING TAKEN TO THE EMERGENCY ROOM. THE REPORT NOTED THAT THE PATIENT WAS HYPERGLYCEMIC WITH BLOOD GLUCOSE READINGS IN THE 400S "FOR DAYS" AND HAD KETONES PRESENT. THE DEVICE WAS DESCRIBED AS HAVING A LOW BIAS INACCURACY, WHICH DIRECTLY IMPACTED CLINICAL TREATMENT DECISIONS. NO ADDITIONAL DETAILS WERE PROVIDED, AND THE ARTICLE DID NOT DISCLOSE THE PATIENT¿S IDENTITY OR INCLUDE CONTACT INFORMATION FOR THE PARENT. NO FOLLOW-UP INFORMATION WAS AVAILABLE AT THE TIME OF PUBLICATION. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA.
Report #41 - 3004753838-2025-273777 CRITICAL
View on MAUDE
Date of Event 2025-09-01
Patient Gender Male
Patient Age NA
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. H6 MEDICAL DEVICE PROBLEM CODE - 3191. PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. | IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. ACCORDING TO THE REPORTER, ON APPROXIMATELY (B)(6)2025, THE PATIENT EXPERIENCED SEVERE HYPOGLYCEMIA AT HOME. THE PATIENT WAS UNCONSCIOUS AND CONVULSED (SEIZURES), WHILE THEIR BLOOD GLUCOSE WAS 0.6 MMOL/L. THEIR HCP WAS NOT ABLE TO DETERMINE THE CAUSE FOR THE EVENT. THERE WAS NO DOCUMENTATION ABOUT THE MEDICAL INTERVENTION NOR THE TREATMENT. NO DATA OR PRODUCT WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #42 - 3004753838-2025-259494 CRITICAL
View on MAUDE
Date of Event 2025-09-01
Patient Gender N/A
Patient Age N/A
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. | IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ACCORDING TO THE PATIENT, ON (B)(6) 2025, WHILE IN THE LIVING ROOM THEY FELT FUNNY AND DECIDED TO CHECK THEIR BLOOD GLUCOSE (BG). THE PATIENT ATTEMPTED TO GO DOWNSTAIRS BUT WAS UNABLE TO DUE TO LOSING CONSCIOUSNESS. THE PATIENT'S MOTHER FOUND THE PATIENT AND CALLED THE AMBULANCE. UPON ARRIVAL, PARAMEDICS CHECKED THE PATIENT¿S BG WHICH WAS AT 40 MG/DL. THEY TREATED THE PATIENT WITH SUGAR IN A BAG AND THE PATIENT REGAINED CONSCIOUSNESS. THE BG WAS 59 MG/DL AFTER 15 MINUTES OF TREATMENT. THE PARAMEDICS CONTINUED TREATMENT UNTIL THE PATIENT¿S BG REACHED A NORMAL RANGE. THE PARAMEDICS ADVISED THE PATIENT TO GO TO THE HOSPITAL, BUT THE PATIENT DECLINED. AT THE TIME OF THE REPORT, THE PATIENT WAS FEELING BETTER. DATA HAS BEEN REQUESTED BUT IS PENDING EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Report #43 - 3004753838-2025-258742 CRITICAL
View on MAUDE
Date of Event 2025-09-01
Patient Gender Female
Patient Age 55 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT'S SENSOR WAS INITIALLY WORKING FINE WITHOUT ISSUES. THEN ON THE SAME DAY AROUND 7:00 PM, SHE WAS WENT UNCONSCIOUS AND WAS FOUND BY HER ROOMMATE. SHE HAD NO SYMPTOMS PRIOR TO IT FAILING AND SHE CAN NO LONGER REMEMBER THE READING THAT SHE GOT PRIOR TO THE SENSOR FAILING SINCE SHE DID NOT CHECK THE RECEIVER AT THAT TIME. SHE WAS ALSO NOT SURE AT WHAT POINT THE SENSOR FAILED. HER ROOMMATE GAVE HER INSTA-GLUCOSE (LIQUID CHERRY GEL) AS TREATMENT WITHOUT KNOWING HER BGM VALUE. AT AROUND 10 PM, SHE WAS ALREADY CONSCIOUS. SHE DID NOT GO TO THE HOSPITAL. AT PRESENT, SHE IS STILL NOT FEELING FINE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Report #44 - 3004753838-2025-258949 CRITICAL
View on MAUDE
Date of Event 2025-09-01
Patient Gender Female
Patient Age 53 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON 09/01/2025, IT WAS REPORTED THAT THE PATIENT GOT UP TO GO TO THE BATHROOM, FELL, AND EXPERIENCED LOSS OF CONSCIOUSNESS. WHEN A FINGERSTICK WAS TAKEN BY THE PATIENT'S DAUGHTER THE CGM READING WAS 170 MG/DL, AND THE BLOOD GLUCOSE READING WAS 62 MG/DL. THE PATIENT WAS TREATED WITH GLUCOSE GEL AND RECOVERED AFTER TREATMENT. THE PATIENT WAS NOT BROUGHT TO THE HOSPITAL. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #45 - 3004753838-2025-256556 CRITICAL
View on MAUDE
Date of Event 2025-09-01
Patient Gender Female
Patient Age 47 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). H6 MEDICAL DEVICE PROBLEM CODE: 3191: PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED THAT SENSOR FAILURE OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT RECEIVED A SENSOR FAILURE AND THEREFORE, WAS NOT RECEIVING ANY CGM VALUES. THE PATIENT WAS WEARING A TANDEM INSULIN PUMP. THERE WAS NO DOCUMENTATION ON WHETHER THE PATIENT WAS USING A BG METER AS A BACK-UP AFTER THE SENSOR FAILURE. AT AN UNSPECIFIED TIME LATER THE SAME DAY, THE PATIENT EXPERIENCED FOUR SEIZURES. THE SEIZURES WERE "SUSPECTED" TO BE TRIGGERED BY HYPOGLYCEMIA. HOWEVER, IT WAS NOTED THAT THE PATIENT DOES ALSO HAVE SEIZURES FROM PRE-EXISTING LONG-TERM BRAIN DAMAGE DUE TO A TRAUMATIC ACCIDENT 31 YEARS AGO WHERE SHE WAS STRUCK BY A DRUNK DRIVER AND WAS IN THE COMA FOR TWO MONTHS. IT WAS ALSO STATED THAT THE PATIENT HAS "MULTIPLE CHRONIC CONDITIONS". THE PATIENT TREATED THE SEIZURES AT HOME WITH JUICE THAT THE PATIENT KEEPS AT THEIR BEDSIDE TABLE. THE FOLLOWING ARE ALSO THE DAILY MEDICATIONS THAT THE PATIENT TAKES: INSULIN, X-COPRI, ATORVASTATIN, LISINOPRIL, AND VIMPAT. THE PATIENT DID NOT SEEK ANY ASSISTANCE FROM A HIGHER LEVEL OF CARE. AFTER THE SEIZURES AND AT THE TIME OF REPORT, THE PATIENT FELT TIRED. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION AND PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #46 - 3004753838-2025-255255 CRITICAL
View on MAUDE
Date of Event 2025-09-01
Patient Gender Female
Patient Age 8 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2025. ACCORDING TO THE REPORTER, ON (B)(6) 2025, THE PATIENT FAINTED, EYES ROLLED BACK, LIPS WERE BLUE. THE PATIENT WAS TAKEN TO THE HOSPITAL BY THE MOTHER. THE PATIENT WAS TREATED WITH CAPRISUN, GLUCOSE, AND BREAD ROLL WITH CHOCOLATE SPREAD BY HER MOTHER. THERE WAS NO TREATMENT INFORMATION PROVIDED AT THE HOSPITAL. AT AN UNSPECIFIED TIME OF THE EVENT THE CGM WAS READING 90 MG/DL AND THE BLOOD GLUCOSE READING WAS 30 MG/DL. AT THE TIME OF THE REPORT THE PATIENT WAS WELL. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #47 - 3004753838-2025-263231 CRITICAL
View on MAUDE
Date of Event 2025-08-30
Patient Gender Female
Patient Age 79 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT HAD APNEA WITH HYPOGLYCEMIC SHOCK AFTER THE WEARABLE FAILED ON THE "RECEIVER" SOMETIME AFTER THE SENSOR WAS PUT ON THE ARM. THE PATIENT USES TANDEM T SLIM AND THIS COMPLAINT SAYS IT WAS NOT IN MODIFIED CLOSED LOOP. ON (B)(6), THE PATIENT WAS SLEEPING AND HER HUSBAND WAS TRYING TO WAKE HER UP. HER HUSBAND FOUND OUT THAT SHE WASN'T BREATHING. SO HER HUSBAND CALL THE EMERGENCY AND SHE WAS BROUGHT TO THE HOSPITAL. HER HUSBAND DID NOT ADMINISTER ANY MEDICATION WAITING FOR THE EMERGENCY. WHEN THEY ARRIVED AT THE CLINIC, THEY PRICKED HER FINGER AND SHE WAS 21 MG/DL. NO CGM READING WAS NOTED, AS HER WEARABLE HAD ALREADY FAILED. REVERSAL OF HYPOGLYCEMIC SHOCK WAS UNREMEMBERED. THE SENSOR WAS REPLACED AND THE NEW CGM WAS NOT REMEMBERED. SHE WAS ADVISED TO STAY FOR 6 HRS FOR MONITORING. SHE CONFIRMED THAT SHE WAS NOT GIVEN ANY MEDICATION OR ANY FOOD INTAKE. AFTER 6 HRS , SHE WAS SENT HOME WITHOUT ANY MEDICATION GIVEN AS SHE DID NOT HAVE ANY SYMPTOMS AND IS WAS FELLING OKAY. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #48 - 3004753838-2025-256703 CRITICAL
View on MAUDE
Date of Event 2025-08-30
Patient Gender Male
Patient Age 77 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT'S CGM WAS 79 MG/DL. THE PATIENT WAS UNABLE TO CALIBRATE THE DEVICE DUE TO PASSING OUT WITHOUT SYMPTOMS SHORTLY AFTER SEEING THE CGM READING. A NEIGHBOR FOUND THE PATIENT UNRESPONSIVE AND CALLED PARAMEDICS. UPON ARRIVAL, THE PARAMEDICS MEASURED THE PATIENT'S BLOOD SUGAR AND IT WAS 35 MG/DL. THE PATIENT WAS TREATED WITH A GLUCAGON INJECTION. THE PATIENT WAS TAKEN TO THE HOSPITAL AND REGAINED CONSCIOUSNESS. HE WAS KEPT OVERNIGHT FOR OBSERVATION. ON (B)(6) 2025, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. UPON DISCHARGE, THIS BG WAS 200 MG/DL BUT WAS UNABLE TO RECALL THE CGM READING. AT THE TIME OF THE REPORT, THE PATIENT WAS DOING WELL. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #49 - 3004753838-2025-255727 CRITICAL
View on MAUDE
Date of Event 2025-08-30
Patient Gender Female
Patient Age 5 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT¿S CGM WAS READING 99 MG/DL. THE PATIENT WAS LOOKING PALE AND EVENTUALLY LOST CONSCIOUSNESS. THE PATIENT¿S PARENT TOOK A BG METER READING AND IT WAS 32 MG/DL. THE PATIENT WAS WEARING AN OMNIPOD INSULIN PUMP. EMERGENCY MEDICAL SERVICES (EMS) WAS CALLED AND ONCE THEY ARRIVED, THE PATIENT WAS TREATED WITH GLUCAGON. EMS STAYED WITH THE PATIENT FOR APPROXIMATELY 30 MINUTES AND THEN LEFT. PRIOR TO LEAVING, THE PATIENT¿S BG METER READING WAS 88 MG/DL. THE PATIENT WAS ¿OKAY, ACTIVE, AND PLAYING¿ AT THE TIME OF REPORT. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #50 - 3004753838-2025-253944 CRITICAL
View on MAUDE
Date of Event 2025-08-30
Patient Gender Male
Patient Age 37 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ABDOMEN WHICH IS AN OFF-LABEL USAGE OF THE DEVICE ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT PASSED OUT FROM HYPOGLYCEMIC SHOCK 8 DAYS AFTER THE SENSOR WAS PUT ON THE ABDOMEN. THE PATIENT USES BETA BIONIC ILET PANCREAS SYSTEM. A BYSTANDER CALLED AN AMBULANCE, AND THE PATIENT WAS TRANSPORTED TO THE EMERGENCY DEPARTMENT (ED). UPON ARRIVAL AT THE EMERGENCY ROOM, THE PARAMEDICS MEASURED THE PATIENT¿S BLOOD GLUCOSE (BG) USING A METER, WHICH READ 30 MG/DL, WHILE THE CGM WAS 72 MG/DL. DURING THE EMERGENCY ROOM (ER) VISIT, THE PATIENT SUFFERED A SEIZURE AND REMAINED UNCONSCIOUS FOR APPROXIMATELY 10 MINUTES. REVERSAL OF HYPOGLYCEMIC SHOCK WAS NOT DOCUMENTED. MEDICATION FOR OTHER CONDITIONS WAS GIVEN. HE REMAINED IN THE ER FOR ABOUT FIVE HOURS AND WAS DISCHARGED AROUND 4:00 PM WITH A BG METER READING OF 130 MG/DL AND A CGM READING OF 242 MG/DL. ATTEMPTS TO CALIBRATE THE SENSOR IN THE ER WERE UNSUCCESSFUL. AFTER RETURNING HOME, THE PATIENT CONTINUED USING THE SAME SENSOR BUT ENCOUNTERED AN ISSUE WHEN TRYING TO INSERT A NEW ONE, AS THE WIRE WAS LOOPING THROUGH THE INSERTION HOLE. THE PATIENT REPORTED FEELING EXHAUSTED AT PRESENT AND MENTIONED TAKING 1500 MG OF TYLENOL THE PREVIOUS NIGHT AROUND 9:00 PM, ALTHOUGH HE WAS UNCERTAIN ABOUT THE EXACT DOSAGE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID WAS TAKEN PRIOR TO ER DISCHARGE. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #51 - 3004753838-2025-268073 CRITICAL
View on MAUDE
Date of Event 2025-08-29
Patient Gender Female
Patient Age 44 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. ACCORDING TO THE PATIENT, ON (B)(6) 2025, WHILE THE PATIENT WAS RESTING, THE PATIENT SUDDENLY BEGAN YELLING FOR APPROXIMATELY TWO MINUTES, FOLLOWED BY MOANING AND GRUNTING, AND THEN BECAME UNRESPONSIVE. A FRIEND CALLED EMERGENCY SERVICES. UPON ARRIVAL, THE PARAMEDICS ASSESSED THE SITUATION. THE PATIENT HAD LOST CONSCIOUSNESS DUE TO HYPOGLYCEMIA. ATTEMPTS BY EMS TO ADMINISTER GLUCOSE GEL WERE UNSUCCESSFUL, PROMPTING THE PARAMEDICS TO ADMINISTER D50 INTRAVENOUSLY. EMS PERFORMED A FINGERSTICK, HOWEVER THE PATIENT WAS UNABLE TO PROVIDE THE VALUE. AFTER RECEIVING TREATMENT, THE PATIENT REGAINED CONSCIOUSNESS BUT REPORTED FEELING DRAINED AND UNWELL. SYMPTOMS FOLLOWING THE EPISODE INCLUDED HEADACHE AND FATIGUE. THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. IT HAS BEEN REPORTED THAT THERE WAS A DIFFERENCE IN READINGS OF 100 POINTS. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. H6: HEALTH EFFECT - CLINICAL CODE - 4592 - DELIRIUM. | A4 - WEIGHT: CORRECTION H2: CORRECTION H6 - TYPE OF INVESTIGATION: CORRECTION | SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED.
Report #52 - 3004753838-2025-257181 CRITICAL
View on MAUDE
Date of Event 2025-08-28
Patient Gender Female
Patient Age 60 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. ON (B)(6) 2025, THE PATIENT WAS AT HOME GETTING READY FOR WORK WHEN SHE EXPERIENCED A MEDICAL EMERGENCY RELATED TO DIABETIC KETOACIDOSIS (DKA). SHE DID NOT HEAR THE ALERT/ALARM ASSOCIATED WITH HER CONDITION WHICH SHE EVENTUALLY LOST CONSCIOUSNESS. THE PATIENT'S DAUGHTER BECAME CONCERNED WHEN SHE WAS UNABLE TO REACH THE PATIENT. SHE ATTEMPTED TO CONTACT HER MOTHER DIRECTLY AND EVEN CHECKED WITH HER WORKPLACE, BUT THE PATIENT HAD NOT SHOWN UP. AS SHE WAS LOCATED FAR FROM HER MOTHER AT THE TIME, SHE CALLED 911 AND REQUESTED A WELLNESS CHECK. EMERGENCY RESPONDERS ARRIVED AND FOUND THE PATIENT LYING UNCONSCIOUS ON THE FLOOR. SHE WAS IMMEDIATELY TRANSPORTED TO THE HOSPITAL. THE PATIENT REMAINED HOSPITALIZED FOR APPROXIMATELY 3¿4 DAYS. DATA HAS BEEN REQUESTED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS.
Report #53 - 3004753838-2025-257199 CRITICAL
View on MAUDE
Date of Event 2025-08-28
Patient Gender Male
Patient Age 54 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT'S DEXCOM APP DISPLAYED ¿LOW¿. THE PATIENT COULD NOT RECALL THE GLUCOSE VALUE OF THE FINGERSTICK THAT WAS TAKEN. HE ATTEMPTED TO CALIBRATE THE SENSOR, BUT THE READINGS DIDN'T MATCH (UNSPECIFIED VALUE). THE PATIENT BEGAN FEELING DIZZY AND EVENTUALLY LOST CONSCIOUSNESS. THE PATIENT'S SON CALLED 911. WHEN THE AMBULANCE ARRIVED, PARAMEDICS ADMINISTERED A GLUCOSE IV. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM, WHERE HE WAS GIVEN FOOD (UNSPECIFIED) AND MONITORED. THE PATIENT STAYED AT THE HOSPITAL FOR A FEW HOURS UNTIL HIS CONDITION STABILIZED. AT THE TIME OF THE CONTACT, HE CONFIRMED THAT HE WAS BACK TO NORMAL AND IN STABLE CONDITION. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #54 - 3004753838-2025-263291 CRITICAL
View on MAUDE
Date of Event 2025-08-26
Patient Gender Female
Patient Age 29 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4) DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS. | IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. THE DATE OF EVENT IS AN APPROXIMATION. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT WOKE UP THE PATIENT REPORTED SHE WAS SWEATING, VOMITING, AND HAD INCREASED URINATION. THE PATIENT¿S CGM WAS READING ¿REPLACE SENSOR NOW¿, BUT NO FURTHER DETAILS ON THE TYPE OF ERROR MESSAGE PROVIDED TO THE PATIENT WAS REPORTED. THE PATIENT TESTED HER BG METER READING, WHICH WAS APPROXIMATELY 900 MG/DL. THE PATIENT WAS WEARING AN UNSPECIFIED BRAND OF INSULIN PUMP. THE PATIENT¿S HUSBAND TOOK HER TO THE EMERGENCY ROOM (ER). AT THE ER, THE PATIENT¿S BG LEVEL WAS 900 MG/DL AND THE PATIENT¿S SENSOR WAS REMOVED. THE PATIENT WAS DIAGNOSED WITH DKA AND TREATED WITH INSULIN. THE PATIENT ALSO MENTIONED BEING IN A COMA AT SOME POINT, BUT NO FURTHER DETAILS ABOUT THIS WERE MENTIONED. THE PATIENT WAS DISCHARGED ON (B)(6) 2025. THE PATIENT REFUSED TO PROVIDE DEXCOM WITH ANY FURTHER EVENT DETAILS. NO OTHER PATIENT OR EVENT DETAILS WERE AVAILABLE. DATA HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Report #55 - 3004753838-2025-256312 CRITICAL
View on MAUDE
Date of Event 2025-08-26
Patient Gender Female
Patient Age 84 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. ON THE NIGHT OF (B)(6) 2025, THE PATIENT EXPERIENCED A SEIZURE AND BECAME UNRESPONSIVE. EMERGENCY MEDICAL SERVICES WERE CONTACTED, AND UPON ARRIVAL, PARAMEDICS RECORDED A CGM READING OF 209 MG/DL, WHILE A FINGER STICK BLOOD GLUCOSE MEASUREMENT SHOWED 49 MG/DL. TREATMENT FOR HYPOGLYCEMIC SHOCK WAS NOT DOCUMENTED. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM AT APPROXIMATELY 2:00 AM ON (B)(6) 2025, AND HOSPITALIZED. MEDICATION WAS ADMINISTERED FOR THE SEIZURE, THOUGH SPECIFIC DETAILS WERE NOT AVAILABLE FROM THE REPORTER. DURING HOSPITALIZATION, THE PATIENT¿S BLOOD GLUCOSE LEVELS WERE MONITORED BEFORE EACH MEAL USING FINGER STICK TESTING, AND THE READINGS CONSISTENTLY DIFFERED FROM THE CGM VALUES. EXACT BGM AND CGM READINGS WERE NOT PROVIDED. THE PATIENT CONTINUED RECEIVING HER REGULAR DIABETES MEDICATIONS, THOUGH NO SPECIFICS WERE REPORTED. CURRENTLY, THE PATIENT¿S FINGER STICK GLUCOSE READINGS HAVE IMPROVED, BUT CGM READINGS REMAIN INACCURATE. THE PATIENT REMAINS HOSPITALIZED AND UNDER OBSERVATION. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.
Report #56 - MW5175930 CRITICAL
View on MAUDE
Date of Event 2025-08-26
Patient Gender Female
Patient Age
Device DEXCOM G7 (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
I AM AN INSULIN PUMP-DEPENDENT DIABETIC. MY REGULAR DIABETIC SUPPLY COMPANY SENT ME MY REGULAR SUPPLY OF 9 G7 DEXCOM SENSORS. WHEN I GOT THEM ON (B)(6), ALL 9 SENSORS WERE DEFECTIVE, UNUSABLE-THEY WERE ALL DATE-STAMPED AS MANUFACTURED 1/7/2025. I CONTACTED DEXCOM TO ASK FOR REPLACEMENTS (B)(6) THEY SENT 8 BY FEDEX AND EMAILED ME A VOUCHER FOR ONE. I HAVEN'T BEEN ABLE TO USE THE VOUCHER: THERE IS A MEDICARE RULE THAT A PRESCRIPTION MUST BE ON FILE AT THE PHARMACY IN ORDER TO USE THE VOUCHER, AND IT IS SO RESTRICTIVE I HAVE NOW BEEN WAITING OVER A WEEK FOR THE PHARMACY TO DISPENSE IT TO ME! THEY WON'T ACCEPT THE CURRENT PRESCRIPTION; THEY WANT A NEW SPECIFICALLY WORDED SCRIPT ... I HAD TO WAIT FOR 10 DAYS FOR THE OTHER 8 SENSORS, BECAUSE THEIR CLAIM OF 5-7 DAYS WAIT FOR ORDER TO ARRIVE IS A JOKE! WHEN THEY ARRIVED (B)(6), I NOTICED THEY WERE ALL MANUFACTURED ON 1/7/2025, SO I OPENED ALL 8 BOXES AND ALL OF THE SENSORS WERE DEFECTIVE, ALL THE APPLICATORS' SPRING-LOADED BUTTONS WERE FLAT AGAINST THE DEVICE, SO THERE WAS NO WAY TO APPLY THE SENSORS, AS THE TRIGGER BUTTON WAS FLAT...AND WOULD NOT DEPLOY THE SENSOR. I IMMEDIATELY CALLED DEXCOM AND REPORTED THE 8 "REPLACEMENT" SENSORS WERE DEFECTIVE. I ASKED THEM TO EXPEDITE AT LEAST ONE SENSOR AS I AM NOT ELIGIBLE TO RECEIVE BLOOD METER SUPPLIES COVERED BY MEDICARE (BECAUSE AS A DEXCOM PRESCRIPTION CUSTOMER I AM NOT ELIGIBLE TO HAVE MEDICARE-COVERED BLOOD GLUCOSE MONITORING DEVICES OR SUPPLIES!! I HAVE NOW GONE TWO WEEKS WITHOUT A WAY TO ACCURATELY ADMINISTER THE PROPER AMOUNT OF INSULIN--I CAN'T AFFORD TO BUY GLUCOSE MONITORING STRIPS FOR AN OLD METER I HAVE THAT IS OVER 5 YEARS OLD...SO EVERY DAY I AM AT RISK OF A HIGH BLOOD SUGAR COMA, OR A HYPOGLYCEMIC COMA. DEXCOM SENSORS ARE NOT BEING MANUFACTURED CORRECTLY, AND EVEN THE "SAMPLE" SENSOR I GOT TODAY FROM MY DOCTOR'S OFFICE WAS ALSO DEFECTIVE, MANUFACTURED 5/1/2025, NOT LIKE THE 20 FAULTY SENSORS (MANUFACTURED 1/7/2025) I'VE ALREADY OPENED AND FOUND DEFECTIVE!! DEXCOM IS PUTTING PEOPLE AT RISK OF SERIOUS ILLNESS AND DEATH, BY REFUSING TO REMOVE DEFECTIVE SENSORS FROM CIRCULATION! PLEASE DO SOMETHING ABOUT THIS INCOMPREHENSIBLE LACK OF INTEGRITY AND RESPONSIBILITY! HECC: 4582. DPC: 2588, 3015. REFERENCE REPORTS: MW5175931, MW5175932, MW5175933, MW5175934, MW5175935, MW5175936, MW5175937, MW5175938, MW5175939, MW5175940, MW5175941, MW5175942, MW5175943, MW5175944, MW5175945, MW5175946, MW5175947.
Report #57 - MW5175931 CRITICAL
View on MAUDE
Date of Event 2025-08-26
Patient Gender Female
Patient Age
Device DEXCOM G7 (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
I AM AN INSULIN PUMP-DEPENDENT DIABETIC. MY REGULAR DIABETIC SUPPLY COMPANY SENT ME MY REGULAR SUPPLY OF 9 G7 DEXCOM SENSORS. WHEN I GOT THEM ON (B)(6), ALL 9 SENSORS WERE DEFECTIVE, UNUSABLE-THEY WERE ALL DATE-STAMPED AS MANUFACTURED 1/7/2025. I CONTACTED DEXCOM TO ASK FOR REPLACEMENTS (B)(6). THEY SENT 8 BY FEDEX AND EMAILED ME A VOUCHER FOR ONE. I HAVEN'T BEEN ABLE TO USE THE VOUCHER: THERE IS A MEDICARE RULE THAT A PRESCRIPTION MUST BE ON FILE AT THE PHARMACY IN ORDER TO USE THE VOUCHER, AND IT IS SO RESTRICTIVE I HAVE NOW BEEN WAITING OVER A WEEK FOR THE PHARMACY TO DISPENSE IT TO ME! THEY WON'T ACCEPT THE CURRENT PRESCRIPTION; THEY WANT A NEW SPECIFICALLY WORDED SCRIPT ... I HAD TO WAIT FOR 10 DAYS FOR THE OTHER 8 SENSORS, BECAUSE THEIR CLAIM OF 5-7 DAYS WAIT FOR ORDER TO ARRIVE IS A JOKE! WHEN THEY ARRIVED (B)(6), I NOTICED THEY WERE ALL MANUFACTURED ON 1/7/2025, SO I OPENED ALL 8 BOXES AND ALL OF THE SENSORS WERE DEFECTIVE, ALL THE APPLICATORS' SPRING-LOADED BUTTONS WERE FLAT AGAINST THE DEVICE, SO THERE WAS NO WAY TO APPLY THE SENSORS, AS THE TRIGGER BUTTON WAS FLAT...AND WOULD NOT DEPLOY THE SENSOR. I IMMEDIATELY CALLED DEXCOM AND REPORTED THE 8 "REPLACEMENT" SENSORS WERE DEFECTIVE. I ASKED THEM TO EXPEDITE AT LEAST ONE SENSOR AS I AM NOT ELIGIBLE TO RECEIVE BLOOD METER SUPPLIES COVERED BY MEDICARE (BECAUSE AS A DEXCOM PRESCRIPTION CUSTOMER I AM NOT ELIGIBLE TO HAVE MEDICARE-COVERED BLOOD GLUCOSE MONITORING DEVICES OR SUPPLIES!! I HAVE NOW GONE TWO WEEKS WITHOUT A WAY TO ACCURATELY ADMINISTER THE PROPER AMOUNT OF INSULIN--I CAN'T AFFORD TO BUY GLUCOSE MONITORING STRIPS FOR AN OLD METER I HAVE THAT IS OVER 5 YEARS OLD...SO EVERY DAY I AM AT RISK OF A HIGH BLOOD SUGAR COMA, OR A HYPOGLYCEMIC COMA. DEXCOM SENSORS ARE NOT BEING MANUFACTURED CORRECTLY, AND EVEN THE "SAMPLE" SENSOR I GOT TODAY FROM MY DOCTOR'S OFFICE WAS ALSO DEFECTIVE, MANUFACTURED 5/1/2025, NOT LIKE THE 20 FAULTY SENSORS (MANUFACTURED 1/7/2025) I'VE ALREADY OPENED AND FOUND DEFECTIVE!! DEXCOM IS PUTTING PEOPLE AT RISK OF SERIOUS ILLNESS AND DEATH, BY REFUSING TO REMOVE DEFECTIVE SENSORS FROM CIRCULATION! PLEASE DO SOMETHING ABOUT THIS INCOMPREHENSIBLE LACK OF INTEGRITY AND RESPONSIBILITY! HECC: 4582. DPC: 2588, 3015. REFERENCE REPORTS: MW5175930, MW5175932, MW5175933, MW5175934, MW5175935, MW5175936, MW5175937, MW5175938, MW5175939, MW5175940, MW5175941, MW5175942, MW5175943, MW5175944, MW5175945, MW5175946, MW5175947.
Report #58 - MW5175932 CRITICAL
View on MAUDE
Date of Event 2025-08-26
Patient Gender Female
Patient Age 68 YR
Device DEXCOM G7 (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
I AM AN INSULIN PUMP-DEPENDENT DIABETIC. MY REGULAR DIABETIC SUPPLY COMPANY SENT ME MY REGULAR SUPPLY OF 9 G7 DEXCOM SENSORS. WHEN I GOT THEM ON (B)(6), ALL 9 SENSORS WERE DEFECTIVE, UNUSABLE-THEY WERE ALL DATE-STAMPED AS MANUFACTURED 1/7/2025. I CONTACTED DEXCOM TO ASK FOR REPLACEMENTS (B)(6). THEY SENT 8 BY FEDEX AND EMAILED ME A VOUCHER FOR ONE. I HAVEN'T BEEN ABLE TO USE THE VOUCHER: THERE IS A MEDICARE RULE THAT A PRESCRIPTION MUST BE ON FILE AT THE PHARMACY IN ORDER TO USE THE VOUCHER, AND IT IS SO RESTRICTIVE I HAVE NOW BEEN WAITING OVER A WEEK FOR THE PHARMACY TO DISPENSE IT TO ME! THEY WON'T ACCEPT THE CURRENT PRESCRIPTION; THEY WANT A NEW SPECIFICALLY WORDED SCRIPT ... I HAD TO WAIT FOR 10 DAYS FOR THE OTHER 8 SENSORS, BECAUSE THEIR CLAIM OF 5-7 DAYS WAIT FOR ORDER TO ARRIVE IS A JOKE! WHEN THEY ARRIVED (B)(6), I NOTICED THEY WERE ALL MANUFACTURED ON 1/7/2025, SO I OPENED ALL 8 BOXES AND ALL OF THE SENSORS WERE DEFECTIVE, ALL THE APPLICATORS' SPRING-LOADED BUTTONS WERE FLAT AGAINST THE DEVICE, SO THERE WAS NO WAY TO APPLY THE SENSORS, AS THE TRIGGER BUTTON WAS FLAT...AND WOULD NOT DEPLOY THE SENSOR. I IMMEDIATELY CALLED DEXCOM AND REPORTED THE 8 "REPLACEMENT" SENSORS WERE DEFECTIVE. I ASKED THEM TO EXPEDITE AT LEAST ONE SENSOR AS I AM NOT ELIGIBLE TO RECEIVE BLOOD METER SUPPLIES COVERED BY MEDICARE (BECAUSE AS A DEXCOM PRESCRIPTION CUSTOMER I AM NOT ELIGIBLE TO HAVE MEDICARE-COVERED BLOOD GLUCOSE MONITORING DEVICES OR SUPPLIES!! I HAVE NOW GONE TWO WEEKS WITHOUT A WAY TO ACCURATELY ADMINISTER THE PROPER AMOUNT OF INSULIN--I CAN'T AFFORD TO BUY GLUCOSE MONITORING STRIPS FOR AN OLD METER I HAVE THAT IS OVER 5 YEARS OLD...SO EVERY DAY I AM AT RISK OF A HIGH BLOOD SUGAR COMA, OR A HYPOGLYCEMIC COMA. DEXCOM SENSORS ARE NOT BEING MANUFACTURED CORRECTLY, AND EVEN THE "SAMPLE" SENSOR I GOT TODAY FROM MY DOCTOR'S OFFICE WAS ALSO DEFECTIVE, MANUFACTURED 5/1/2025, NOT LIKE THE 20 FAULTY SENSORS (MANUFACTURED 1/7/2025) I'VE ALREADY OPENED AND FOUND DEFECTIVE!! DEXCOM IS PUTTING PEOPLE AT RISK OF SERIOUS ILLNESS AND DEATH, BY REFUSING TO REMOVE DEFECTIVE SENSORS FROM CIRCULATION! PLEASE DO SOMETHING ABOUT THIS INCOMPREHENSIBLE LACK OF INTEGRITY AND RESPONSIBILITY! HECC: 4582. DPC: 2588, 3015. REFERENCE REPORTS: MW5175930, MW5175931, MW5175933, MW5175934, MW5175935, MW5175936, MW5175937, MW5175938, MW5175939, MW5175940, MW5175941, MW5175942, MW5175943, MW5175944, MW5175945, MW5175946, MW5175947.
Report #59 - MW5175933 CRITICAL
View on MAUDE
Date of Event 2025-08-26
Patient Gender Female
Patient Age 68 YR
Device DEXCOM G7 (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
I AM AN INSULIN PUMP-DEPENDENT DIABETIC. MY REGULAR DIABETIC SUPPLY COMPANY SENT ME MY REGULAR SUPPLY OF 9 G7 DEXCOM SENSORS. WHEN I GOT THEM ON (B)(6), ALL 9 SENSORS WERE DEFECTIVE, UNUSABLE-THEY WERE ALL DATE-STAMPED AS MANUFACTURED 1/7/2025. I CONTACTED DEXCOM TO ASK FOR REPLACEMENTS (B)(6). THEY SENT 8 BY FEDEX AND EMAILED ME A VOUCHER FOR ONE. I HAVEN'T BEEN ABLE TO USE THE VOUCHER: THERE IS A MEDICARE RULE THAT A PRESCRIPTION MUST BE ON FILE AT THE PHARMACY IN ORDER TO USE THE VOUCHER, AND IT IS SO RESTRICTIVE I HAVE NOW BEEN WAITING OVER A WEEK FOR THE PHARMACY TO DISPENSE IT TO ME! THEY WON'T ACCEPT THE CURRENT PRESCRIPTION; THEY WANT A NEW SPECIFICALLY WORDED SCRIPT ... I HAD TO WAIT FOR 10 DAYS FOR THE OTHER 8 SENSORS, BECAUSE THEIR CLAIM OF 5-7 DAYS WAIT FOR ORDER TO ARRIVE IS A JOKE! WHEN THEY ARRIVED (B)(6), I NOTICED THEY WERE ALL MANUFACTURED ON 1/7/2025, SO I OPENED ALL 8 BOXES AND ALL OF THE SENSORS WERE DEFECTIVE, ALL THE APPLICATORS' SPRING-LOADED BUTTONS WERE FLAT AGAINST THE DEVICE, SO THERE WAS NO WAY TO APPLY THE SENSORS, AS THE TRIGGER BUTTON WAS FLAT...AND WOULD NOT DEPLOY THE SENSOR. I IMMEDIATELY CALLED DEXCOM AND REPORTED THE 8 "REPLACEMENT" SENSORS WERE DEFECTIVE. I ASKED THEM TO EXPEDITE AT LEAST ONE SENSOR AS I AM NOT ELIGIBLE TO RECEIVE BLOOD METER SUPPLIES COVERED BY MEDICARE (BECAUSE AS A DEXCOM PRESCRIPTION CUSTOMER I AM NOT ELIGIBLE TO HAVE MEDICARE-COVERED BLOOD GLUCOSE MONITORING DEVICES OR SUPPLIES!! I HAVE NOW GONE TWO WEEKS WITHOUT A WAY TO ACCURATELY ADMINISTER THE PROPER AMOUNT OF INSULIN--I CAN'T AFFORD TO BUY GLUCOSE MONITORING STRIPS FOR AN OLD METER I HAVE THAT IS OVER 5 YEARS OLD...SO EVERY DAY I AM AT RISK OF A HIGH BLOOD SUGAR COMA, OR A HYPOGLYCEMIC COMA. DEXCOM SENSORS ARE NOT BEING MANUFACTURED CORRECTLY, AND EVEN THE "SAMPLE" SENSOR I GOT TODAY FROM MY DOCTOR'S OFFICE WAS ALSO DEFECTIVE, MANUFACTURED 5/1/2025, NOT LIKE THE 20 FAULTY SENSORS (MANUFACTURED 1/7/2025) I'VE ALREADY OPENED AND FOUND DEFECTIVE!! DEXCOM IS PUTTING PEOPLE AT RISK OF SERIOUS ILLNESS AND DEATH, BY REFUSING TO REMOVE DEFECTIVE SENSORS FROM CIRCULATION! PLEASE DO SOMETHING ABOUT THIS INCOMPREHENSIBLE LACK OF INTEGRITY AND RESPONSIBILITY! HECC: 4582. DPC: 2588, 3015. REFERENCE REPORTS: MW5175930, MW5175931, MW5175932, MW5175934, MW5175935, MW5175936, MW5175937, MW5175938, MW5175939, MW5175940, MW5175941, MW5175942, MW5175943, MW5175944, MW5175945, MW5175946, MW5175947.
Report #60 - MW5175934 CRITICAL
View on MAUDE
Date of Event 2025-08-26
Patient Gender Female
Patient Age 68 YR
Device DEXCOM G7 (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
I AM AN INSULIN PUMP-DEPENDENT DIABETIC. MY REGULAR DIABETIC SUPPLY COMPANY SENT ME MY REGULAR SUPPLY OF 9 G7 DEXCOM SENSORS. WHEN I GOT THEM ON (B)(6), ALL 9 SENSORS WERE DEFECTIVE, UNUSABLE-THEY WERE ALL DATE-STAMPED AS MANUFACTURED 1/7/2025. I CONTACTED DEXCOM TO ASK FOR REPLACEMENTS (B)(6). THEY SENT 8 BY FEDEX AND EMAILED ME A VOUCHER FOR ONE. I HAVEN'T BEEN ABLE TO USE THE VOUCHER: THERE IS A MEDICARE RULE THAT A PRESCRIPTION MUST BE ON FILE AT THE PHARMACY IN ORDER TO USE THE VOUCHER, AND IT IS SO RESTRICTIVE I HAVE NOW BEEN WAITING OVER A WEEK FOR THE PHARMACY TO DISPENSE IT TO ME! THEY WON'T ACCEPT THE CURRENT PRESCRIPTION; THEY WANT A NEW SPECIFICALLY WORDED SCRIPT ... I HAD TO WAIT FOR 10 DAYS FOR THE OTHER 8 SENSORS, BECAUSE THEIR CLAIM OF 5-7 DAYS WAIT FOR ORDER TO ARRIVE IS A JOKE! WHEN THEY ARRIVED (B)(6), I NOTICED THEY WERE ALL MANUFACTURED ON 1/7/2025, SO I OPENED ALL 8 BOXES AND ALL OF THE SENSORS WERE DEFECTIVE, ALL THE APPLICATORS' SPRING-LOADED BUTTONS WERE FLAT AGAINST THE DEVICE, SO THERE WAS NO WAY TO APPLY THE SENSORS, AS THE TRIGGER BUTTON WAS FLAT...AND WOULD NOT DEPLOY THE SENSOR. I IMMEDIATELY CALLED DEXCOM AND REPORTED THE 8 "REPLACEMENT" SENSORS WERE DEFECTIVE. I ASKED THEM TO EXPEDITE AT LEAST ONE SENSOR AS I AM NOT ELIGIBLE TO RECEIVE BLOOD METER SUPPLIES COVERED BY MEDICARE (BECAUSE AS A DEXCOM PRESCRIPTION CUSTOMER I AM NOT ELIGIBLE TO HAVE MEDICARE-COVERED BLOOD GLUCOSE MONITORING DEVICES OR SUPPLIES!! I HAVE NOW GONE TWO WEEKS WITHOUT A WAY TO ACCURATELY ADMINISTER THE PROPER AMOUNT OF INSULIN--I CAN'T AFFORD TO BUY GLUCOSE MONITORING STRIPS FOR AN OLD METER I HAVE THAT IS OVER 5 YEARS OLD...SO EVERY DAY I AM AT RISK OF A HIGH BLOOD SUGAR COMA, OR A HYPOGLYCEMIC COMA. DEXCOM SENSORS ARE NOT BEING MANUFACTURED CORRECTLY, AND EVEN THE "SAMPLE" SENSOR I GOT TODAY FROM MY DOCTOR'S OFFICE WAS ALSO DEFECTIVE, MANUFACTURED 5/1/2025, NOT LIKE THE 20 FAULTY SENSORS (MANUFACTURED 1/7/2025) I'VE ALREADY OPENED AND FOUND DEFECTIVE!! DEXCOM IS PUTTING PEOPLE AT RISK OF SERIOUS ILLNESS AND DEATH, BY REFUSING TO REMOVE DEFECTIVE SENSORS FROM CIRCULATION! PLEASE DO SOMETHING ABOUT THIS INCOMPREHENSIBLE LACK OF INTEGRITY AND RESPONSIBILITY! HECC: 4582. DPC: 2588, 3015. REFERENCE REPORTS: MW5175930, MW5175931, MW5175932, MW5175933, MW5175935, MW5175936, MW5175937, MW5175938, MW5175939, MW5175940, MW5175941, MW5175942, MW5175943, MW5175944, MW5175945, MW5175946, MW5175947.
Report #61 - MW5175935 CRITICAL
View on MAUDE
Date of Event 2025-08-26
Patient Gender Female
Patient Age 68 YR
Device DEXCOM G7 (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
I AM AN INSULIN PUMP-DEPENDENT DIABETIC. MY REGULAR DIABETIC SUPPLY COMPANY SENT ME MY REGULAR SUPPLY OF 9 G7 DEXCOM SENSORS. WHEN I GOT THEM ON (B)(6), ALL 9 SENSORS WERE DEFECTIVE, UNUSABLE-THEY WERE ALL DATE-STAMPED AS MANUFACTURED 1/7/2025. I CONTACTED DEXCOM TO ASK FOR REPLACEMENTS (B)(6). THEY SENT 8 BY FEDEX AND EMAILED ME A VOUCHER FOR ONE. I HAVEN'T BEEN ABLE TO USE THE VOUCHER: THERE IS A MEDICARE RULE THAT A PRESCRIPTION MUST BE ON FILE AT THE PHARMACY IN ORDER TO USE THE VOUCHER, AND IT IS SO RESTRICTIVE I HAVE NOW BEEN WAITING OVER A WEEK FOR THE PHARMACY TO DISPENSE IT TO ME! THEY WON'T ACCEPT THE CURRENT PRESCRIPTION; THEY WANT A NEW SPECIFICALLY WORDED SCRIPT ... I HAD TO WAIT FOR 10 DAYS FOR THE OTHER 8 SENSORS, BECAUSE THEIR CLAIM OF 5-7 DAYS WAIT FOR ORDER TO ARRIVE IS A JOKE! WHEN THEY ARRIVED (B)(6), I NOTICED THEY WERE ALL MANUFACTURED ON 1/7/2025, SO I OPENED ALL 8 BOXES AND ALL OF THE SENSORS WERE DEFECTIVE, ALL THE APPLICATORS' SPRING-LOADED BUTTONS WERE FLAT AGAINST THE DEVICE, SO THERE WAS NO WAY TO APPLY THE SENSORS, AS THE TRIGGER BUTTON WAS FLAT...AND WOULD NOT DEPLOY THE SENSOR. I IMMEDIATELY CALLED DEXCOM AND REPORTED THE 8 "REPLACEMENT" SENSORS WERE DEFECTIVE. I ASKED THEM TO EXPEDITE AT LEAST ONE SENSOR AS I AM NOT ELIGIBLE TO RECEIVE BLOOD METER SUPPLIES COVERED BY MEDICARE (BECAUSE AS A DEXCOM PRESCRIPTION CUSTOMER I AM NOT ELIGIBLE TO HAVE MEDICARE-COVERED BLOOD GLUCOSE MONITORING DEVICES OR SUPPLIES!! I HAVE NOW GONE TWO WEEKS WITHOUT A WAY TO ACCURATELY ADMINISTER THE PROPER AMOUNT OF INSULIN--I CAN'T AFFORD TO BUY GLUCOSE MONITORING STRIPS FOR AN OLD METER I HAVE THAT IS OVER 5 YEARS OLD...SO EVERY DAY I AM AT RISK OF A HIGH BLOOD SUGAR COMA, OR A HYPOGLYCEMIC COMA. DEXCOM SENSORS ARE NOT BEING MANUFACTURED CORRECTLY, AND EVEN THE "SAMPLE" SENSOR I GOT TODAY FROM MY DOCTOR'S OFFICE WAS ALSO DEFECTIVE, MANUFACTURED 5/1/2025, NOT LIKE THE 20 FAULTY SENSORS (MANUFACTURED 1/7/2025) I'VE ALREADY OPENED AND FOUND DEFECTIVE!! DEXCOM IS PUTTING PEOPLE AT RISK OF SERIOUS ILLNESS AND DEATH, BY REFUSING TO REMOVE DEFECTIVE SENSORS FROM CIRCULATION! PLEASE DO SOMETHING ABOUT THIS INCOMPREHENSIBLE LACK OF INTEGRITY AND RESPONSIBILITY! HECC: 4582. DPC: 2588, 3015. REFERENCE REPORTS: MW5175930, MW5175931, MW5175932, MW5175933, MW5175934, MW5175936, MW5175937, MW5175938, MW5175939, MW5175940, MW5175941, MW5175942, MW5175943, MW5175944, MW5175945, MW5175946, MW5175947.
Report #62 - MW5175936 CRITICAL
View on MAUDE
Date of Event 2025-08-26
Patient Gender Female
Patient Age 68 YR
Device DEXCOM G7 (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
I AM AN INSULIN PUMP-DEPENDENT DIABETIC. MY REGULAR DIABETIC SUPPLY COMPANY SENT ME MY REGULAR SUPPLY OF 9 G7 DEXCOM SENSORS. WHEN I GOT THEM ON (B)(6) 2025, ALL 9 SENSORS WERE DEFECTIVE, UNUSABLE-THEY WERE ALL DATE-STAMPED AS MANUFACTURED 1/7/2025. I CONTACTED DEXCOM TO ASK FOR REPLACEMENTS (B)(6) 2025. THEY SENT 8 BY FEDEX AND EMAILED ME A VOUCHER FOR ONE. I HAVEN'T BEEN ABLE TO USE THE VOUCHER: THERE IS A MEDICARE RULE THAT A PRESCRIPTION MUST BE ON FILE AT THE PHARMACY IN ORDER TO USE THE VOUCHER, AND IT IS SO RESTRICTIVE I HAVE NOW BEEN WAITING OVER A WEEK FOR THE PHARMACY TO DISPENSE IT TO ME! THEY WON'T ACCEPT THE CURRENT PRESCRIPTION; THEY WANT A NEW SPECIFICALLY WORDED SCRIPT ... I HAD TO WAIT FOR 10 DAYS FOR THE OTHER 8 SENSORS, BECAUSE THEIR CLAIM OF 5-7 DAYS WAIT FOR ORDER TO ARRIVE IS A JOKE! WHEN THEY ARRIVED (B)(6) 2025, I NOTICED THEY WERE ALL MANUFACTURED ON 1/7/2025, SO I OPENED ALL 8 BOXES AND ALL OF THE SENSORS WERE DEFECTIVE, ALL THE APPLICATORS' SPRING-LOADED BUTTONS WERE FLAT AGAINST THE DEVICE, SO THERE WAS NO WAY TO APPLY THE SENSORS, AS THE TRIGGER BUTTON WAS FLAT...AND WOULD NOT DEPLOY THE SENSOR. I IMMEDIATELY CALLED DEXCOM AND REPORTED THE 8 "REPLACEMENT" SENSORS WERE DEFECTIVE. I ASKED THEM TO EXPEDITE AT LEAST ONE SENSOR AS I AM NOT ELIGIBLE TO RECEIVE BLOOD METER SUPPLIES COVERED BY MEDICARE (BECAUSE AS A DEXCOM PRESCRIPTION CUSTOMER I AM NOT ELIGIBLE TO HAVE MEDICARE-COVERED BLOOD GLUCOSE MONITORING DEVICES OR SUPPLIES!! I HAVE NOW GONE TWO WEEKS WITHOUT A WAY TO ACCURATELY ADMINISTER THE PROPER AMOUNT OF INSULIN--I CAN'T AFFORD TO BUY GLUCOSE MONITORING STRIPS FOR AN OLD METER I HAVE THAT IS OVER 5 YEARS OLD...SO EVERY DAY I AM AT RISK OF A HIGH BLOOD SUGAR COMA, OR A HYPOGLYCEMIC COMA. DEXCOM SENSORS ARE NOT BEING MANUFACTURED CORRECTLY, AND EVEN THE "SAMPLE" SENSOR I GOT TODAY FROM MY DOCTOR'S OFFICE WAS ALSO DEFECTIVE, MANUFACTURED 5/1/2025, NOT LIKE THE 20 FAULTY SENSORS (MANUFACTURED 1/7/2025) I'VE ALREADY OPENED AND FOUND DEFECTIVE!! DEXCOM IS PUTTING PEOPLE AT RISK OF SERIOUS ILLNESS AND DEATH, BY REFUSING TO REMOVE DEFECTIVE SENSORS FROM CIRCULATION! PLEASE DO SOMETHING ABOUT THIS INCOMPREHENSIBLE LACK OF INTEGRITY AND RESPONSIBILITY! HECC: 4582. DPC: 2588, 3015. REFERENCE REPORTS: MW5175930 , MW5175931 , MW5175932 , MW5175933 , MW5175934 , MW5175935 , MW5175937 , MW5175938 , MW5175939 , MW5175940 , MW5175941 , MW5175942 , MW5175943 , MW5175944 , MW5175945 , MW5175946 , MW5175947.
Report #63 - MW5175937 CRITICAL
View on MAUDE
Date of Event 2025-08-26
Patient Gender Female
Patient Age 68 YR
Device DEXCOM G7 (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
I AM AN INSULIN PUMP-DEPENDENT DIABETIC. MY REGULAR DIABETIC SUPPLY COMPANY SENT ME MY REGULAR SUPPLY OF 9 G7 DEXCOM SENSORS. WHEN I GOT THEM ON (B)(6), ALL 9 SENSORS WERE DEFECTIVE, UNUSABLE-THEY WERE ALL DATE-STAMPED AS MANUFACTURED 1/7/2025. I CONTACTED DEXCOM TO ASK FOR REPLACEMENTS (B)(6). THEY SENT 8 BY FEDEX AND EMAILED ME A VOUCHER FOR ONE. I HAVEN'T BEEN ABLE TO USE THE VOUCHER: THERE IS A MEDICARE RULE THAT A PRESCRIPTION MUST BE ON FILE AT THE PHARMACY IN ORDER TO USE THE VOUCHER, AND IT IS SO RESTRICTIVE I HAVE NOW BEEN WAITING OVER A WEEK FOR THE PHARMACY TO DISPENSE IT TO ME! THEY WON'T ACCEPT THE CURRENT PRESCRIPTION; THEY WANT A NEW SPECIFICALLY WORDED SCRIPT ... I HAD TO WAIT FOR 10 DAYS FOR THE OTHER 8 SENSORS, BECAUSE THEIR CLAIM OF 5-7 DAYS WAIT FOR ORDER TO ARRIVE IS A JOKE! WHEN THEY ARRIVED (B)(6), I NOTICED THEY WERE ALL MANUFACTURED ON 1/7/2025, SO I OPENED ALL 8 BOXES AND ALL OF THE SENSORS WERE DEFECTIVE, ALL THE APPLICATORS' SPRING-LOADED BUTTONS WERE FLAT AGAINST THE DEVICE, SO THERE WAS NO WAY TO APPLY THE SENSORS, AS THE TRIGGER BUTTON WAS FLAT...AND WOULD NOT DEPLOY THE SENSOR. I IMMEDIATELY CALLED DEXCOM AND REPORTED THE 8 "REPLACEMENT" SENSORS WERE DEFECTIVE. I ASKED THEM TO EXPEDITE AT LEAST ONE SENSOR AS I AM NOT ELIGIBLE TO RECEIVE BLOOD METER SUPPLIES COVERED BY MEDICARE (BECAUSE AS A DEXCOM PRESCRIPTION CUSTOMER I AM NOT ELIGIBLE TO HAVE MEDICARE-COVERED BLOOD GLUCOSE MONITORING DEVICES OR SUPPLIES!! I HAVE NOW GONE TWO WEEKS WITHOUT A WAY TO ACCURATELY ADMINISTER THE PROPER AMOUNT OF INSULIN--I CAN'T AFFORD TO BUY GLUCOSE MONITORING STRIPS FOR AN OLD METER I HAVE THAT IS OVER 5 YEARS OLD...SO EVERY DAY I AM AT RISK OF A HIGH BLOOD SUGAR COMA, OR A HYPOGLYCEMIC COMA. DEXCOM SENSORS ARE NOT BEING MANUFACTURED CORRECTLY, AND EVEN THE "SAMPLE" SENSOR I GOT TODAY FROM MY DOCTOR'S OFFICE WAS ALSO DEFECTIVE, MANUFACTURED 5/1/2025, NOT LIKE THE 20 FAULTY SENSORS (MANUFACTURED 1/7/2025) I'VE ALREADY OPENED AND FOUND DEFECTIVE!! DEXCOM IS PUTTING PEOPLE AT RISK OF SERIOUS ILLNESS AND DEATH, BY REFUSING TO REMOVE DEFECTIVE SENSORS FROM CIRCULATION! PLEASE DO SOMETHING ABOUT THIS INCOMPREHENSIBLE LACK OF INTEGRITY AND RESPONSIBILITY! HECC: 4582. DPC: 2588, 3015. REFERENCE REPORTS: MW5175930, MW5175931, MW5175932, MW5175933, MW5175934, MW5175935, MW5175936, MW5175938, MW5175939, MW5175940, MW5175941, MW5175942, MW5175943, MW5175944, MW5175945, MW5175946, MW5175947.
Report #64 - MW5175938 CRITICAL
View on MAUDE
Date of Event 2025-08-26
Patient Gender Female
Patient Age 68 YR
Device DEXCOM G7 (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
I AM AN INSULIN PUMP-DEPENDENT DIABETIC. MY REGULAR DIABETIC SUPPLY COMPANY SENT ME MY REGULAR SUPPLY OF 9 G7 DEXCOM SENSORS. WHEN I GOT THEM ON (B)(6), ALL 9 SENSORS WERE DEFECTIVE, UNUSABLE-THEY WERE ALL DATE-STAMPED AS MANUFACTURED 1/7/2025. I CONTACTED DEXCOM TO ASK FOR REPLACEMENTS (B)(6). THEY SENT 8 BY FEDEX AND EMAILED ME A VOUCHER FOR ONE. I HAVEN'T BEEN ABLE TO USE THE VOUCHER: THERE IS A MEDICARE RULE THAT A PRESCRIPTION MUST BE ON FILE AT THE PHARMACY IN ORDER TO USE THE VOUCHER, AND IT IS SO RESTRICTIVE I HAVE NOW BEEN WAITING OVER A WEEK FOR THE PHARMACY TO DISPENSE IT TO ME! THEY WON'T ACCEPT THE CURRENT PRESCRIPTION; THEY WANT A NEW SPECIFICALLY WORDED SCRIPT ... I HAD TO WAIT FOR 10 DAYS FOR THE OTHER 8 SENSORS, BECAUSE THEIR CLAIM OF 5-7 DAYS WAIT FOR ORDER TO ARRIVE IS A JOKE! WHEN THEY ARRIVED (B)(6), I NOTICED THEY WERE ALL MANUFACTURED ON 1/7/2025, SO I OPENED ALL 8 BOXES AND ALL OF THE SENSORS WERE DEFECTIVE, ALL THE APPLICATORS' SPRING-LOADED BUTTONS WERE FLAT AGAINST THE DEVICE, SO THERE WAS NO WAY TO APPLY THE SENSORS, AS THE TRIGGER BUTTON WAS FLAT...AND WOULD NOT DEPLOY THE SENSOR. I IMMEDIATELY CALLED DEXCOM AND REPORTED THE 8 "REPLACEMENT" SENSORS WERE DEFECTIVE. I ASKED THEM TO EXPEDITE AT LEAST ONE SENSOR AS I AM NOT ELIGIBLE TO RECEIVE BLOOD METER SUPPLIES COVERED BY MEDICARE (BECAUSE AS A DEXCOM PRESCRIPTION CUSTOMER I AM NOT ELIGIBLE TO HAVE MEDICARE-COVERED BLOOD GLUCOSE MONITORING DEVICES OR SUPPLIES!! I HAVE NOW GONE TWO WEEKS WITHOUT A WAY TO ACCURATELY ADMINISTER THE PROPER AMOUNT OF INSULIN--I CAN'T AFFORD TO BUY GLUCOSE MONITORING STRIPS FOR AN OLD METER I HAVE THAT IS OVER 5 YEARS OLD...SO EVERY DAY I AM AT RISK OF A HIGH BLOOD SUGAR COMA, OR A HYPOGLYCEMIC COMA. DEXCOM SENSORS ARE NOT BEING MANUFACTURED CORRECTLY, AND EVEN THE "SAMPLE" SENSOR I GOT TODAY FROM MY DOCTOR'S OFFICE WAS ALSO DEFECTIVE, MANUFACTURED 5/1/2025, NOT LIKE THE 20 FAULTY SENSORS (MANUFACTURED 1/7/2025) I'VE ALREADY OPENED AND FOUND DEFECTIVE!! DEXCOM IS PUTTING PEOPLE AT RISK OF SERIOUS ILLNESS AND DEATH, BY REFUSING TO REMOVE DEFECTIVE SENSORS FROM CIRCULATION! PLEASE DO SOMETHING ABOUT THIS INCOMPREHENSIBLE LACK OF INTEGRITY AND RESPONSIBILITY! HECC: 4582. DPC: 2588, 3015. REFERENCE REPORTS: MW5175930, MW5175931, MW5175932, MW5175933, MW5175934, MW5175935, MW5175936, MW5175937, MW5175939, MW5175940, MW5175941, MW5175942, MW5175943, MW5175944, MW5175945, MW5175946, MW5175947.
Report #65 - MW5175939 CRITICAL
View on MAUDE
Date of Event 2025-08-26
Patient Gender Female
Patient Age 68 YR
Device DEXCOM G7 (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
I AM AN INSULIN PUMP-DEPENDENT DIABETIC. MY REGULAR DIABETIC SUPPLY COMPANY SENT ME MY REGULAR SUPPLY OF 9 G7 DEXCOM SENSORS. WHEN I GOT THEM ON (B)(6), ALL 9 SENSORS WERE DEFECTIVE, UNUSABLE-THEY WERE ALL DATE-STAMPED AS MANUFACTURED 1/7/2025. I CONTACTED DEXCOM TO ASK FOR REPLACEMENTS (B)(6). THEY SENT 8 BY FEDEX AND EMAILED ME A VOUCHER FOR ONE. I HAVEN'T BEEN ABLE TO USE THE VOUCHER: THERE IS A MEDICARE RULE THAT A PRESCRIPTION MUST BE ON FILE AT THE PHARMACY IN ORDER TO USE THE VOUCHER, AND IT IS SO RESTRICTIVE I HAVE NOW BEEN WAITING OVER A WEEK FOR THE PHARMACY TO DISPENSE IT TO ME! THEY WON'T ACCEPT THE CURRENT PRESCRIPTION; THEY WANT A NEW SPECIFICALLY WORDED SCRIPT ... I HAD TO WAIT FOR 10 DAYS FOR THE OTHER 8 SENSORS, BECAUSE THEIR CLAIM OF 5-7 DAYS WAIT FOR ORDER TO ARRIVE IS A JOKE! WHEN THEY ARRIVED (B)(6), I NOTICED THEY WERE ALL MANUFACTURED ON 1/7/2025, SO I OPENED ALL 8 BOXES AND ALL OF THE SENSORS WERE DEFECTIVE, ALL THE APPLICATORS' SPRING-LOADED BUTTONS WERE FLAT AGAINST THE DEVICE, SO THERE WAS NO WAY TO APPLY THE SENSORS, AS THE TRIGGER BUTTON WAS FLAT...AND WOULD NOT DEPLOY THE SENSOR. I IMMEDIATELY CALLED DEXCOM AND REPORTED THE 8 "REPLACEMENT" SENSORS WERE DEFECTIVE. I ASKED THEM TO EXPEDITE AT LEAST ONE SENSOR AS I AM NOT ELIGIBLE TO RECEIVE BLOOD METER SUPPLIES COVERED BY MEDICARE (BECAUSE AS A DEXCOM PRESCRIPTION CUSTOMER I AM NOT ELIGIBLE TO HAVE MEDICARE-COVERED BLOOD GLUCOSE MONITORING DEVICES OR SUPPLIES!! I HAVE NOW GONE TWO WEEKS WITHOUT A WAY TO ACCURATELY ADMINISTER THE PROPER AMOUNT OF INSULIN--I CAN'T AFFORD TO BUY GLUCOSE MONITORING STRIPS FOR AN OLD METER I HAVE THAT IS OVER 5 YEARS OLD...SO EVERY DAY I AM AT RISK OF A HIGH BLOOD SUGAR COMA, OR A HYPOGLYCEMIC COMA. DEXCOM SENSORS ARE NOT BEING MANUFACTURED CORRECTLY, AND EVEN THE "SAMPLE" SENSOR I GOT TODAY FROM MY DOCTOR'S OFFICE WAS ALSO DEFECTIVE, MANUFACTURED 5/1/2025, NOT LIKE THE 20 FAULTY SENSORS (MANUFACTURED 1/7/2025) I'VE ALREADY OPENED AND FOUND DEFECTIVE!! DEXCOM IS PUTTING PEOPLE AT RISK OF SERIOUS ILLNESS AND DEATH, BY REFUSING TO REMOVE DEFECTIVE SENSORS FROM CIRCULATION! PLEASE DO SOMETHING ABOUT THIS INCOMPREHENSIBLE LACK OF INTEGRITY AND RESPONSIBILITY! HECC: 4582. DPC: 2588, 3015. REFERENCE REPORTS: MW5175930, MW5175931, MW5175932, MW5175933, MW5175934, MW5175935, MW5175936, MW5175937, MW5175938, MW5175940, MW5175941, MW5175942, MW5175943, MW5175944, MW5175945, MW5175946, MW5175947.
Report #66 - MW5175940 CRITICAL
View on MAUDE
Date of Event 2025-08-26
Patient Gender Female
Patient Age 68 YR
Device DEXCOM G7 (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
I AM AN INSULIN PUMP-DEPENDENT DIABETIC. MY REGULAR DIABETIC SUPPLY COMPANY SENT ME MY REGULAR SUPPLY OF 9 G7 DEXCOM SENSORS. WHEN I GOT THEM ON (B)(6), ALL 9 SENSORS WERE DEFECTIVE, UNUSABLE-THEY WERE ALL DATE-STAMPED AS MANUFACTURED 1/7/2025. I CONTACTED DEXCOM TO ASK FOR REPLACEMENTS (B)(6). THEY SENT 8 BY FEDEX AND EMAILED ME A VOUCHER FOR ONE. I HAVEN'T BEEN ABLE TO USE THE VOUCHER: THERE IS A MEDICARE RULE THAT A PRESCRIPTION MUST BE ON FILE AT THE PHARMACY IN ORDER TO USE THE VOUCHER, AND IT IS SO RESTRICTIVE I HAVE NOW BEEN WAITING OVER A WEEK FOR THE PHARMACY TO DISPENSE IT TO ME! THEY WON'T ACCEPT THE CURRENT PRESCRIPTION; THEY WANT A NEW SPECIFICALLY WORDED SCRIPT ... I HAD TO WAIT FOR 10 DAYS FOR THE OTHER 8 SENSORS, BECAUSE THEIR CLAIM OF 5-7 DAYS WAIT FOR ORDER TO ARRIVE IS A JOKE! WHEN THEY ARRIVED (B)(6), I NOTICED THEY WERE ALL MANUFACTURED ON 1/7/2025, SO I OPENED ALL 8 BOXES AND ALL OF THE SENSORS WERE DEFECTIVE, ALL THE APPLICATORS' SPRING-LOADED BUTTONS WERE FLAT AGAINST THE DEVICE, SO THERE WAS NO WAY TO APPLY THE SENSORS, AS THE TRIGGER BUTTON WAS FLAT...AND WOULD NOT DEPLOY THE SENSOR. I IMMEDIATELY CALLED DEXCOM AND REPORTED THE 8 "REPLACEMENT" SENSORS WERE DEFECTIVE. I ASKED THEM TO EXPEDITE AT LEAST ONE SENSOR AS I AM NOT ELIGIBLE TO RECEIVE BLOOD METER SUPPLIES COVERED BY MEDICARE (BECAUSE AS A DEXCOM PRESCRIPTION CUSTOMER I AM NOT ELIGIBLE TO HAVE MEDICARE-COVERED BLOOD GLUCOSE MONITORING DEVICES OR SUPPLIES!! I HAVE NOW GONE TWO WEEKS WITHOUT A WAY TO ACCURATELY ADMINISTER THE PROPER AMOUNT OF INSULIN--I CAN'T AFFORD TO BUY GLUCOSE MONITORING STRIPS FOR AN OLD METER I HAVE THAT IS OVER 5 YEARS OLD...SO EVERY DAY I AM AT RISK OF A HIGH BLOOD SUGAR COMA, OR A HYPOGLYCEMIC COMA. DEXCOM SENSORS ARE NOT BEING MANUFACTURED CORRECTLY, AND EVEN THE "SAMPLE" SENSOR I GOT TODAY FROM MY DOCTOR'S OFFICE WAS ALSO DEFECTIVE, MANUFACTURED 5/1/2025, NOT LIKE THE 20 FAULTY SENSORS (MANUFACTURED 1/7/2025) I'VE ALREADY OPENED AND FOUND DEFECTIVE!! DEXCOM IS PUTTING PEOPLE AT RISK OF SERIOUS ILLNESS AND DEATH, BY REFUSING TO REMOVE DEFECTIVE SENSORS FROM CIRCULATION! PLEASE DO SOMETHING ABOUT THIS INCOMPREHENSIBLE LACK OF INTEGRITY AND RESPONSIBILITY! HECC: 4582. DPC: 2588, 3015. REFERENCE REPORTS: MW5175930, MW5175931, MW5175932, MW5175933, MW5175934, MW5175935, MW5175936, MW5175937, MW5175938, MW5175939, MW5175941, MW5175942, MW5175943, MW5175944, MW5175945, MW5175946, MW5175947.
Report #67 - MW5175941 CRITICAL
View on MAUDE
Date of Event 2025-08-26
Patient Gender Female
Patient Age 68 YR
Device DEXCOM G7 (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
I AM AN INSULIN PUMP-DEPENDENT DIABETIC. MY REGULAR DIABETIC SUPPLY COMPANY SENT ME MY REGULAR SUPPLY OF 9 G7 DEXCOM SENSORS. WHEN I GOT THEM ON (B)(6), ALL 9 SENSORS WERE DEFECTIVE, UNUSABLE-THEY WERE ALL DATE-STAMPED AS MANUFACTURED 1/7/2025. I CONTACTED DEXCOM TO ASK FOR REPLACEMENTS (B)(6). THEY SENT 8 BY FEDEX AND EMAILED ME A VOUCHER FOR ONE. I HAVEN'T BEEN ABLE TO USE THE VOUCHER: THERE IS A MEDICARE RULE THAT A PRESCRIPTION MUST BE ON FILE AT THE PHARMACY IN ORDER TO USE THE VOUCHER, AND IT IS SO RESTRICTIVE I HAVE NOW BEEN WAITING OVER A WEEK FOR THE PHARMACY TO DISPENSE IT TO ME! THEY WON'T ACCEPT THE CURRENT PRESCRIPTION; THEY WANT A NEW SPECIFICALLY WORDED SCRIPT ... I HAD TO WAIT FOR 10 DAYS FOR THE OTHER 8 SENSORS, BECAUSE THEIR CLAIM OF 5-7 DAYS WAIT FOR ORDER TO ARRIVE IS A JOKE! WHEN THEY ARRIVED (B)(6), I NOTICED THEY WERE ALL MANUFACTURED ON 1/7/2025, SO I OPENED ALL 8 BOXES AND ALL OF THE SENSORS WERE DEFECTIVE, ALL THE APPLICATORS' SPRING-LOADED BUTTONS WERE FLAT AGAINST THE DEVICE, SO THERE WAS NO WAY TO APPLY THE SENSORS, AS THE TRIGGER BUTTON WAS FLAT...AND WOULD NOT DEPLOY THE SENSOR. I IMMEDIATELY CALLED DEXCOM AND REPORTED THE 8 "REPLACEMENT" SENSORS WERE DEFECTIVE. I ASKED THEM TO EXPEDITE AT LEAST ONE SENSOR AS I AM NOT ELIGIBLE TO RECEIVE BLOOD METER SUPPLIES COVERED BY MEDICARE (BECAUSE AS A DEXCOM PRESCRIPTION CUSTOMER I AM NOT ELIGIBLE TO HAVE MEDICARE-COVERED BLOOD GLUCOSE MONITORING DEVICES OR SUPPLIES!! I HAVE NOW GONE TWO WEEKS WITHOUT A WAY TO ACCURATELY ADMINISTER THE PROPER AMOUNT OF INSULIN--I CAN'T AFFORD TO BUY GLUCOSE MONITORING STRIPS FOR AN OLD METER I HAVE THAT IS OVER 5 YEARS OLD...SO EVERY DAY I AM AT RISK OF A HIGH BLOOD SUGAR COMA, OR A HYPOGLYCEMIC COMA. DEXCOM SENSORS ARE NOT BEING MANUFACTURED CORRECTLY, AND EVEN THE "SAMPLE" SENSOR I GOT TODAY FROM MY DOCTOR'S OFFICE WAS ALSO DEFECTIVE, MANUFACTURED 5/1/2025, NOT LIKE THE 20 FAULTY SENSORS (MANUFACTURED 1/7/2025) I'VE ALREADY OPENED AND FOUND DEFECTIVE!! DEXCOM IS PUTTING PEOPLE AT RISK OF SERIOUS ILLNESS AND DEATH, BY REFUSING TO REMOVE DEFECTIVE SENSORS FROM CIRCULATION! PLEASE DO SOMETHING ABOUT THIS INCOMPREHENSIBLE LACK OF INTEGRITY AND RESPONSIBILITY! HECC: 4582. DPC: 2588, 3015. REFERENCE REPORTS: MW5175930, MW5175931, MW5175932, MW5175933, MW5175934, MW5175935, MW5175936, MW5175937, MW5175938, MW5175939, MW5175940, MW5175942, MW5175943, MW5175944, MW5175945, MW5175946, MW5175947.
Report #68 - MW5175942 CRITICAL
View on MAUDE
Date of Event 2025-08-26
Patient Gender Female
Patient Age 68 YR
Device DEXCOM G7 (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
I AM AN INSULIN PUMP-DEPENDENT DIABETIC. MY REGULAR DIABETIC SUPPLY COMPANY SENT ME MY REGULAR SUPPLY OF 9 G7 DEXCOM SENSORS. WHEN I GOT THEM ON (B)(6), ALL 9 SENSORS WERE DEFECTIVE, UNUSABLE-THEY WERE ALL DATE-STAMPED AS MANUFACTURED 1/7/2025. I CONTACTED DEXCOM TO ASK FOR REPLACEMENTS (B)(6). THEY SENT 8 BY FEDEX AND EMAILED ME A VOUCHER FOR ONE. I HAVEN'T BEEN ABLE TO USE THE VOUCHER: THERE IS A MEDICARE RULE THAT A PRESCRIPTION MUST BE ON FILE AT THE PHARMACY IN ORDER TO USE THE VOUCHER, AND IT IS SO RESTRICTIVE I HAVE NOW BEEN WAITING OVER A WEEK FOR THE PHARMACY TO DISPENSE IT TO ME! THEY WON'T ACCEPT THE CURRENT PRESCRIPTION; THEY WANT A NEW SPECIFICALLY WORDED SCRIPT ... I HAD TO WAIT FOR 10 DAYS FOR THE OTHER 8 SENSORS, BECAUSE THEIR CLAIM OF 5-7 DAYS WAIT FOR ORDER TO ARRIVE IS A JOKE! WHEN THEY ARRIVED (B)(6), I NOTICED THEY WERE ALL MANUFACTURED ON 1/7/2025, SO I OPENED ALL 8 BOXES AND ALL OF THE SENSORS WERE DEFECTIVE, ALL THE APPLICATORS' SPRING-LOADED BUTTONS WERE FLAT AGAINST THE DEVICE, SO THERE WAS NO WAY TO APPLY THE SENSORS, AS THE TRIGGER BUTTON WAS FLAT...AND WOULD NOT DEPLOY THE SENSOR. I IMMEDIATELY CALLED DEXCOM AND REPORTED THE 8 "REPLACEMENT" SENSORS WERE DEFECTIVE. I ASKED THEM TO EXPEDITE AT LEAST ONE SENSOR AS I AM NOT ELIGIBLE TO RECEIVE BLOOD METER SUPPLIES COVERED BY MEDICARE (BECAUSE AS A DEXCOM PRESCRIPTION CUSTOMER I AM NOT ELIGIBLE TO HAVE MEDICARE-COVERED BLOOD GLUCOSE MONITORING DEVICES OR SUPPLIES!! I HAVE NOW GONE TWO WEEKS WITHOUT A WAY TO ACCURATELY ADMINISTER THE PROPER AMOUNT OF INSULIN--I CAN'T AFFORD TO BUY GLUCOSE MONITORING STRIPS FOR AN OLD METER I HAVE THAT IS OVER 5 YEARS OLD...SO EVERY DAY I AM AT RISK OF A HIGH BLOOD SUGAR COMA, OR A HYPOGLYCEMIC COMA. DEXCOM SENSORS ARE NOT BEING MANUFACTURED CORRECTLY, AND EVEN THE "SAMPLE" SENSOR I GOT TODAY FROM MY DOCTOR'S OFFICE WAS ALSO DEFECTIVE, MANUFACTURED 5/1/2025, NOT LIKE THE 20 FAULTY SENSORS (MANUFACTURED 1/7/2025) I'VE ALREADY OPENED AND FOUND DEFECTIVE!! DEXCOM IS PUTTING PEOPLE AT RISK OF SERIOUS ILLNESS AND DEATH, BY REFUSING TO REMOVE DEFECTIVE SENSORS FROM CIRCULATION! PLEASE DO SOMETHING ABOUT THIS INCOMPREHENSIBLE LACK OF INTEGRITY AND RESPONSIBILITY! HECC: 4582. DPC: 2588, 3015. REFERENCE REPORTS: MW5175930, MW5175931, MW5175932, MW5175933, MW5175934, MW5175935, MW5175936, MW5175937, MW5175938, MW5175939, MW5175940, MW5175941, MW5175943, MW5175944, MW5175945, MW5175946, MW5175947.
Report #69 - MW5175943 CRITICAL
View on MAUDE
Date of Event 2025-08-26
Patient Gender Female
Patient Age 68 YR
Device DEXCOM G7 (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
I AM AN INSULIN PUMP-DEPENDENT DIABETIC. MY REGULAR DIABETIC SUPPLY COMPANY SENT ME MY REGULAR SUPPLY OF 9 G7 DEXCOM SENSORS. WHEN I GOT THEM ON (B)(6), ALL 9 SENSORS WERE DEFECTIVE, UNUSABLE-THEY WERE ALL DATE-STAMPED AS MANUFACTURED 1/7/2025. I CONTACTED DEXCOM TO ASK FOR REPLACEMENTS (B)(6). THEY SENT 8 BY FEDEX AND EMAILED ME A VOUCHER FOR ONE. I HAVEN'T BEEN ABLE TO USE THE VOUCHER: THERE IS A MEDICARE RULE THAT A PRESCRIPTION MUST BE ON FILE AT THE PHARMACY IN ORDER TO USE THE VOUCHER, AND IT IS SO RESTRICTIVE I HAVE NOW BEEN WAITING OVER A WEEK FOR THE PHARMACY TO DISPENSE IT TO ME! THEY WON'T ACCEPT THE CURRENT PRESCRIPTION; THEY WANT A NEW SPECIFICALLY WORDED SCRIPT ... I HAD TO WAIT FOR 10 DAYS FOR THE OTHER 8 SENSORS, BECAUSE THEIR CLAIM OF 5-7 DAYS WAIT FOR ORDER TO ARRIVE IS A JOKE! WHEN THEY ARRIVED (B)(6), I NOTICED THEY WERE ALL MANUFACTURED ON 1/7/2025, SO I OPENED ALL 8 BOXES AND ALL OF THE SENSORS WERE DEFECTIVE, ALL THE APPLICATORS' SPRING-LOADED BUTTONS WERE FLAT AGAINST THE DEVICE, SO THERE WAS NO WAY TO APPLY THE SENSORS, AS THE TRIGGER BUTTON WAS FLAT...AND WOULD NOT DEPLOY THE SENSOR. I IMMEDIATELY CALLED DEXCOM AND REPORTED THE 8 "REPLACEMENT" SENSORS WERE DEFECTIVE. I ASKED THEM TO EXPEDITE AT LEAST ONE SENSOR AS I AM NOT ELIGIBLE TO RECEIVE BLOOD METER SUPPLIES COVERED BY MEDICARE (BECAUSE AS A DEXCOM PRESCRIPTION CUSTOMER I AM NOT ELIGIBLE TO HAVE MEDICARE-COVERED BLOOD GLUCOSE MONITORING DEVICES OR SUPPLIES!! I HAVE NOW GONE TWO WEEKS WITHOUT A WAY TO ACCURATELY ADMINISTER THE PROPER AMOUNT OF INSULIN--I CAN'T AFFORD TO BUY GLUCOSE MONITORING STRIPS FOR AN OLD METER I HAVE THAT IS OVER 5 YEARS OLD...SO EVERY DAY I AM AT RISK OF A HIGH BLOOD SUGAR COMA, OR A HYPOGLYCEMIC COMA. DEXCOM SENSORS ARE NOT BEING MANUFACTURED CORRECTLY, AND EVEN THE "SAMPLE" SENSOR I GOT TODAY FROM MY DOCTOR'S OFFICE WAS ALSO DEFECTIVE, MANUFACTURED 5/1/2025, NOT LIKE THE 20 FAULTY SENSORS (MANUFACTURED 1/7/2025) I'VE ALREADY OPENED AND FOUND DEFECTIVE!! DEXCOM IS PUTTING PEOPLE AT RISK OF SERIOUS ILLNESS AND DEATH, BY REFUSING TO REMOVE DEFECTIVE SENSORS FROM CIRCULATION! PLEASE DO SOMETHING ABOUT THIS INCOMPREHENSIBLE LACK OF INTEGRITY AND RESPONSIBILITY! HECC: 4582. DPC: 2588, 3015. REFERENCE REPORTS: MW5175930, MW5175931, MW5175932, MW5175933, MW5175934, MW5175935, MW5175936, MW5175937, MW5175938, MW5175939, MW5175940, MW5175941, MW5175942, MW5175944, MW5175945, MW5175946, MW5175947.
Report #70 - MW5175944 CRITICAL
View on MAUDE
Date of Event 2025-08-26
Patient Gender Female
Patient Age 68 YR
Device DEXCOM G7 (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
I AM AN INSULIN PUMP-DEPENDENT DIABETIC. MY REGULAR DIABETIC SUPPLY COMPANY SENT ME MY REGULAR SUPPLY OF 9 G7 DEXCOM SENSORS. WHEN I GOT THEM ON (B)(6), ALL 9 SENSORS WERE DEFECTIVE, UNUSABLE-THEY WERE ALL DATE-STAMPED AS MANUFACTURED 1/7/2025. I CONTACTED DEXCOM TO ASK FOR REPLACEMENTS (B)(6). THEY SENT 8 BY FEDEX AND EMAILED ME A VOUCHER FOR ONE. I HAVEN'T BEEN ABLE TO USE THE VOUCHER: THERE IS A MEDICARE RULE THAT A PRESCRIPTION MUST BE ON FILE AT THE PHARMACY IN ORDER TO USE THE VOUCHER, AND IT IS SO RESTRICTIVE I HAVE NOW BEEN WAITING OVER A WEEK FOR THE PHARMACY TO DISPENSE IT TO ME! THEY WON'T ACCEPT THE CURRENT PRESCRIPTION; THEY WANT A NEW SPECIFICALLY WORDED SCRIPT ... I HAD TO WAIT FOR 10 DAYS FOR THE OTHER 8 SENSORS, BECAUSE THEIR CLAIM OF 5-7 DAYS WAIT FOR ORDER TO ARRIVE IS A JOKE! WHEN THEY ARRIVED (B)(6), I NOTICED THEY WERE ALL MANUFACTURED ON 1/7/2025, SO I OPENED ALL 8 BOXES AND ALL OF THE SENSORS WERE DEFECTIVE, ALL THE APPLICATORS' SPRING-LOADED BUTTONS WERE FLAT AGAINST THE DEVICE, SO THERE WAS NO WAY TO APPLY THE SENSORS, AS THE TRIGGER BUTTON WAS FLAT...AND WOULD NOT DEPLOY THE SENSOR. I IMMEDIATELY CALLED DEXCOM AND REPORTED THE 8 "REPLACEMENT" SENSORS WERE DEFECTIVE. I ASKED THEM TO EXPEDITE AT LEAST ONE SENSOR AS I AM NOT ELIGIBLE TO RECEIVE BLOOD METER SUPPLIES COVERED BY MEDICARE (BECAUSE AS A DEXCOM PRESCRIPTION CUSTOMER I AM NOT ELIGIBLE TO HAVE MEDICARE-COVERED BLOOD GLUCOSE MONITORING DEVICES OR SUPPLIES!! I HAVE NOW GONE TWO WEEKS WITHOUT A WAY TO ACCURATELY ADMINISTER THE PROPER AMOUNT OF INSULIN--I CAN'T AFFORD TO BUY GLUCOSE MONITORING STRIPS FOR AN OLD METER I HAVE THAT IS OVER 5 YEARS OLD...SO EVERY DAY I AM AT RISK OF A HIGH BLOOD SUGAR COMA, OR A HYPOGLYCEMIC COMA. DEXCOM SENSORS ARE NOT BEING MANUFACTURED CORRECTLY, AND EVEN THE "SAMPLE" SENSOR I GOT TODAY FROM MY DOCTOR'S OFFICE WAS ALSO DEFECTIVE, MANUFACTURED 5/1/2025, NOT LIKE THE 20 FAULTY SENSORS (MANUFACTURED 1/7/2025) I'VE ALREADY OPENED AND FOUND DEFECTIVE!! DEXCOM IS PUTTING PEOPLE AT RISK OF SERIOUS ILLNESS AND DEATH, BY REFUSING TO REMOVE DEFECTIVE SENSORS FROM CIRCULATION! PLEASE DO SOMETHING ABOUT THIS INCOMPREHENSIBLE LACK OF INTEGRITY AND RESPONSIBILITY! HECC: 4582. DPC: 2588, 3015. REFERENCE REPORTS: MW5175930, MW5175931, MW5175932, MW5175933, MW5175934, MW5175935, MW5175936, MW5175937, MW5175938, MW5175939, MW5175940, MW5175941, MW5175942, MW5175943, MW5175945, MW5175946, MW5175947.
Report #71 - MW5175945 CRITICAL
View on MAUDE
Date of Event 2025-08-26
Patient Gender Female
Patient Age 68 YR
Device DEXCOM G7 (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
I AM AN INSULIN PUMP-DEPENDENT DIABETIC. MY REGULAR DIABETIC SUPPLY COMPANY SENT ME MY REGULAR SUPPLY OF 9 G7 DEXCOM SENSORS. WHEN I GOT THEM ON (B)(6), ALL 9 SENSORS WERE DEFECTIVE, UNUSABLE-THEY WERE ALL DATE-STAMPED AS MANUFACTURED 1/7/2025. I CONTACTED DEXCOM TO ASK FOR REPLACEMENTS (B)(6) THEY SENT 8 BY FEDEX AND EMAILED ME A VOUCHER FOR ONE. I HAVEN'T BEEN ABLE TO USE THE VOUCHER: THERE IS A MEDICARE RULE THAT A PRESCRIPTION MUST BE ON FILE AT THE PHARMACY IN ORDER TO USE THE VOUCHER, AND IT IS SO RESTRICTIVE I HAVE NOW BEEN WAITING OVER A WEEK FOR THE PHARMACY TO DISPENSE IT TO ME! THEY WON'T ACCEPT THE CURRENT PRESCRIPTION; THEY WANT A NEW SPECIFICALLY WORDED SCRIPT ... I HAD TO WAIT FOR 10 DAYS FOR THE OTHER 8 SENSORS, BECAUSE THEIR CLAIM OF 5-7 DAYS WAIT FOR ORDER TO ARRIVE IS A JOKE! WHEN THEY ARRIVED (B)(6), I NOTICED THEY WERE ALL MANUFACTURED ON 1/7/2025, SO I OPENED ALL 8 BOXES AND ALL OF THE SENSORS WERE DEFECTIVE, ALL THE APPLICATORS' SPRING-LOADED BUTTONS WERE FLAT AGAINST THE DEVICE, SO THERE WAS NO WAY TO APPLY THE SENSORS, AS THE TRIGGER BUTTON WAS FLAT...AND WOULD NOT DEPLOY THE SENSOR. I IMMEDIATELY CALLED DEXCOM AND REPORTED THE 8 "REPLACEMENT" SENSORS WERE DEFECTIVE. I ASKED THEM TO EXPEDITE AT LEAST ONE SENSOR AS I AM NOT ELIGIBLE TO RECEIVE BLOOD METER SUPPLIES COVERED BY MEDICARE (BECAUSE AS A DEXCOM PRESCRIPTION CUSTOMER I AM NOT ELIGIBLE TO HAVE MEDICARE-COVERED BLOOD GLUCOSE MONITORING DEVICES OR SUPPLIES!! I HAVE NOW GONE TWO WEEKS WITHOUT A WAY TO ACCURATELY ADMINISTER THE PROPER AMOUNT OF INSULIN--I CAN'T AFFORD TO BUY GLUCOSE MONITORING STRIPS FOR AN OLD METER I HAVE THAT IS OVER 5 YEARS OLD...SO EVERY DAY I AM AT RISK OF A HIGH BLOOD SUGAR COMA, OR A HYPOGLYCEMIC COMA. DEXCOM SENSORS ARE NOT BEING MANUFACTURED CORRECTLY, AND EVEN THE "SAMPLE" SENSOR I GOT TODAY FROM MY DOCTOR'S OFFICE WAS ALSO DEFECTIVE, MANUFACTURED 5/1/2025, NOT LIKE THE 20 FAULTY SENSORS (MANUFACTURED 1/7/2025) I'VE ALREADY OPENED AND FOUND DEFECTIVE!! DEXCOM IS PUTTING PEOPLE AT RISK OF SERIOUS ILLNESS AND DEATH, BY REFUSING TO REMOVE DEFECTIVE SENSORS FROM CIRCULATION! PLEASE DO SOMETHING ABOUT THIS INCOMPREHENSIBLE LACK OF INTEGRITY AND RESPONSIBILITY! HECC: 4582. DPC: 2588, 3015. REFERENCE REPORTS: MW5175930, MW5175931, MW5175932, MW5175933, MW5175934, MW5175935, MW5175936, MW5175937, MW5175938, MW5175939, MW5175940, MW5175941, MW5175942, MW5175943, MW5175944, MW5175946, MW5175947.
Report #72 - MW5175946 CRITICAL
View on MAUDE
Date of Event 2025-08-26
Patient Gender Female
Patient Age 68 YR
Device DEXCOM G7 (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
I AM AN INSULIN PUMP-DEPENDENT DIABETIC. MY REGULAR DIABETIC SUPPLY COMPANY SENT ME MY REGULAR SUPPLY OF 9 G7 DEXCOM SENSORS. WHEN I GOT THEM ON (B)(6), ALL 9 SENSORS WERE DEFECTIVE, UNUSABLE-THEY WERE ALL DATE-STAMPED AS MANUFACTURED 1/7/2025. I CONTACTED DEXCOM TO ASK FOR REPLACEMENTS (B)(6). THEY SENT 8 BY FEDEX AND EMAILED ME A VOUCHER FOR ONE. I HAVEN'T BEEN ABLE TO USE THE VOUCHER: THERE IS A MEDICARE RULE THAT A PRESCRIPTION MUST BE ON FILE AT THE PHARMACY IN ORDER TO USE THE VOUCHER, AND IT IS SO RESTRICTIVE I HAVE NOW BEEN WAITING OVER A WEEK FOR THE PHARMACY TO DISPENSE IT TO ME! THEY WON'T ACCEPT THE CURRENT PRESCRIPTION; THEY WANT A NEW SPECIFICALLY WORDED SCRIPT ... I HAD TO WAIT FOR 10 DAYS FOR THE OTHER 8 SENSORS, BECAUSE THEIR CLAIM OF 5-7 DAYS WAIT FOR ORDER TO ARRIVE IS A JOKE! WHEN THEY ARRIVED (B)(6), I NOTICED THEY WERE ALL MANUFACTURED ON 1/7/2025, SO I OPENED ALL 8 BOXES AND ALL OF THE SENSORS WERE DEFECTIVE, ALL THE APPLICATORS' SPRING-LOADED BUTTONS WERE FLAT AGAINST THE DEVICE, SO THERE WAS NO WAY TO APPLY THE SENSORS, AS THE TRIGGER BUTTON WAS FLAT...AND WOULD NOT DEPLOY THE SENSOR. I IMMEDIATELY CALLED DEXCOM AND REPORTED THE 8 "REPLACEMENT" SENSORS WERE DEFECTIVE. I ASKED THEM TO EXPEDITE AT LEAST ONE SENSOR AS I AM NOT ELIGIBLE TO RECEIVE BLOOD METER SUPPLIES COVERED BY MEDICARE (BECAUSE AS A DEXCOM PRESCRIPTION CUSTOMER I AM NOT ELIGIBLE TO HAVE MEDICARE-COVERED BLOOD GLUCOSE MONITORING DEVICES OR SUPPLIES!! I HAVE NOW GONE TWO WEEKS WITHOUT A WAY TO ACCURATELY ADMINISTER THE PROPER AMOUNT OF INSULIN--I CAN'T AFFORD TO BUY GLUCOSE MONITORING STRIPS FOR AN OLD METER I HAVE THAT IS OVER 5 YEARS OLD...SO EVERY DAY I AM AT RISK OF A HIGH BLOOD SUGAR COMA, OR A HYPOGLYCEMIC COMA. DEXCOM SENSORS ARE NOT BEING MANUFACTURED CORRECTLY, AND EVEN THE "SAMPLE" SENSOR I GOT TODAY FROM MY DOCTOR'S OFFICE WAS ALSO DEFECTIVE, MANUFACTURED 5/1/2025, NOT LIKE THE 20 FAULTY SENSORS (MANUFACTURED 1/7/2025) I'VE ALREADY OPENED AND FOUND DEFECTIVE!! DEXCOM IS PUTTING PEOPLE AT RISK OF SERIOUS ILLNESS AND DEATH, BY REFUSING TO REMOVE DEFECTIVE SENSORS FROM CIRCULATION! PLEASE DO SOMETHING ABOUT THIS INCOMPREHENSIBLE LACK OF INTEGRITY AND RESPONSIBILITY! HECC: 4582. DPC: 2588, 3015. REFERENCE REPORTS: MW5175930, MW5175931, MW5175932, MW5175933, MW5175934, MW5175935, MW5175936, MW5175937, MW5175938, MW5175939, MW5175940, MW5175941, MW5175942, MW5175943, MW5175944, MW5175945, MW5175947.
Report #73 - MW5175947 CRITICAL
View on MAUDE
Date of Event 2025-08-26
Patient Gender Female
Patient Age 68 YR
Device DEXCOM G7 (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
I AM AN INSULIN PUMP-DEPENDENT DIABETIC. MY REGULAR DIABETIC SUPPLY COMPANY SENT ME MY REGULAR SUPPLY OF 9 G7 DEXCOM SENSORS. WHEN I GOT THEM ON (B)(6), ALL 9 SENSORS WERE DEFECTIVE, UNUSABLE-THEY WERE ALL DATE-STAMPED AS MANUFACTURED 1/7/2025. I CONTACTED DEXCOM TO ASK FOR REPLACEMENTS (B)(6). THEY SENT 8 BY FEDEX AND EMAILED ME A VOUCHER FOR ONE. I HAVEN'T BEEN ABLE TO USE THE VOUCHER: THERE IS A MEDICARE RULE THAT A PRESCRIPTION MUST BE ON FILE AT THE PHARMACY IN ORDER TO USE THE VOUCHER, AND IT IS SO RESTRICTIVE I HAVE NOW BEEN WAITING OVER A WEEK FOR THE PHARMACY TO DISPENSE IT TO ME! THEY WON'T ACCEPT THE CURRENT PRESCRIPTION; THEY WANT A NEW SPECIFICALLY WORDED SCRIPT ... I HAD TO WAIT FOR 10 DAYS FOR THE OTHER 8 SENSORS, BECAUSE THEIR CLAIM OF 5-7 DAYS WAIT FOR ORDER TO ARRIVE IS A JOKE! WHEN THEY ARRIVED (B)(6), I NOTICED THEY WERE ALL MANUFACTURED ON 1/7/2025, SO I OPENED ALL 8 BOXES AND ALL OF THE SENSORS WERE DEFECTIVE, ALL THE APPLICATORS' SPRING-LOADED BUTTONS WERE FLAT AGAINST THE DEVICE, SO THERE WAS NO WAY TO APPLY THE SENSORS, AS THE TRIGGER BUTTON WAS FLAT...AND WOULD NOT DEPLOY THE SENSOR. I IMMEDIATELY CALLED DEXCOM AND REPORTED THE 8 "REPLACEMENT" SENSORS WERE DEFECTIVE. I ASKED THEM TO EXPEDITE AT LEAST ONE SENSOR AS I AM NOT ELIGIBLE TO RECEIVE BLOOD METER SUPPLIES COVERED BY MEDICARE (BECAUSE AS A DEXCOM PRESCRIPTION CUSTOMER I AM NOT ELIGIBLE TO HAVE MEDICARE-COVERED BLOOD GLUCOSE MONITORING DEVICES OR SUPPLIES!! I HAVE NOW GONE TWO WEEKS WITHOUT A WAY TO ACCURATELY ADMINISTER THE PROPER AMOUNT OF INSULIN--I CAN'T AFFORD TO BUY GLUCOSE MONITORING STRIPS FOR AN OLD METER I HAVE THAT IS OVER 5 YEARS OLD...SO EVERY DAY I AM AT RISK OF A HIGH BLOOD SUGAR COMA, OR A HYPOGLYCEMIC COMA. DEXCOM SENSORS ARE NOT BEING MANUFACTURED CORRECTLY, AND EVEN THE "SAMPLE" SENSOR I GOT TODAY FROM MY DOCTOR'S OFFICE WAS ALSO DEFECTIVE, MANUFACTURED 5/1/2025, NOT LIKE THE 20 FAULTY SENSORS (MANUFACTURED 1/7/2025) I'VE ALREADY OPENED AND FOUND DEFECTIVE!! DEXCOM IS PUTTING PEOPLE AT RISK OF SERIOUS ILLNESS AND DEATH, BY REFUSING TO REMOVE DEFECTIVE SENSORS FROM CIRCULATION! PLEASE DO SOMETHING ABOUT THIS INCOMPREHENSIBLE LACK OF INTEGRITY AND RESPONSIBILITY! HECC: 4582. DPC: 2588, 3015. REFERENCE REPORTS: MW5175930, MW5175931, MW5175932, MW5175933, MW5175934, MW5175935, MW5175936, MW5175937, MW5175938, MW5175939, MW5175940, MW5175941, MW5175942, MW5175943, MW5175944, MW5175945, MW5175946.
Report #74 - 3004753838-2025-250000 CRITICAL
View on MAUDE
Date of Event 2025-08-26
Patient Gender Female
Patient Age 66 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON THE SAME DAY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SENSOR ERROR, AFTER WHICH THEY EXPERIENCED A HYPOGLYCEMIC EVENT. THE MORNING OF THE EVENT THE PATIENT NOTED THE SENSOR ERROR AND LATER AT 09:00AM, THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS. AN AMBULANCE WAS CALLED BY THE PATIENT´S HUSBAND. WHEN A FINGERSTICK WAS TAKEN BY THE PARAMEDICS THE BLOOD GLUCOSE READING WAS 32 MG/DL. THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS AND 2 GLASSES OF CRANBERRY JUICE. AFTER TREATMENT THE BLOOD GLUCOSE READING WAS 237 MG/DL. THE PATIENT RECOVERED AT HOME AND WAS NOT BROUGHT TO THE HOSPITAL. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE AND THE BLOOD GLUCOSE READING WAS 157 MG/DL. NO OTHER DETAILS WERE DOCUMENTED. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #75 - MW5175637 CRITICAL
View on MAUDE
Date of Event 2025-08-25
Patient Gender Male
Patient Age 37 YR
Device DEXCOM G7 (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Yes
Pump Device N/A
Event Description:
IN THE EARLY MORNING OF (B)(6) (SUNDAY NIGHT GOING INTO MONDAY), I WAS WOKEN UP IN THE MIDDLE OF THE NIGHT, AROUND 2:30AM BY THE BLARING ALARM ON MY PHONE FROM THE DEXCOM G7 APP. THE ALARM WAS SCREAMING ABOUT AN URGENT LOW BLOOD SUGAR OR 49 MILLIMOLES PER LITER, REQUIRING IMMEDIATE ACTION. MY BODY DID FEEL LIKE A LOW, WEAK, PANICKY, ESPECIALLY WHEN YOUR PHONE IS BLARING AN ALARM AT YOU AT A HIGH VOLUME. I THEN CHECKED MY GLUCOMETER TO CONFIRM THESE READINGS, BUT MY GLUCOMETER WAS READING APPROX. 340. ALMOST EXACTLY 300 WHOLE POINTS OFF. OBVIOUSLY, I WAS DISTRESSED AND ALARMED BY THE RADICAL DISCREPANCY BETWEEN THE TWO NUMBERS, AND UNSURE HOW TO PROCEED! I TRIED TO USE THE GLUCOMETER READING (WHICH IS ALWAYS SUPPOSED TO BE MORE ACCURATE) TO CALIBRATE THE G7 APP, BUT AT THIS POINT THE APP WAS TELLING ME "SENSOR ERROR", WHICH DOESN'T LET YOU INPUT A CALIBRATION NUMBER. SO, I HAD TO EAT SOME CANDY AND MEDICINE TO TRY TO RAISE MY BLOOD SUGAR IN CASE IT WAS CRITICALLY LOW, AS I WAS HOME ALONE, AND NATURALLY DIDN'T WANT TO GO UNCONSCIOUS FROM A SUGAR LOW AND BE LEFT INCAPACITATED OR UNABLE TO MAKE CLEAR DECISIONS AND WIND UP IN A COMA. I WAS FORCED TO CALL A RIDESHARE TO TAKE ME TO THE EMERGENCY ROOM, BY THIS POINT IT WAS PROBABLY AROUND 3AM OR SO. WHEN I WAS CHECKED IN, THEY ALSO DID A FINGER-STICK GLUCOMETER READING, NOW MY SUGAR WAS HIGHER, APPROX. 378, IF I RECALL CORRECTLY. MY DEXCOM APP WAS STILL GIVING SENSOR ISSUES, SO I STILL COULDN'T RELY ON IT OR EVEN RECALIBRATE IT. I WASN'T RELEASED UNTIL ALMOST 10AM IN THE MORNING. IT TOOK SEVERAL HOURS TO BE ATTENDED. THEY RAN BLOOD TESTS, WHICH CAME BACK FINE. EVENTUALLY I GOT A ROOM AND WAS PUT ON AN IV (INTRAVENOUS). I ALSO WAS MANUALLY TAKING CORRECTION INSULIN DOSES USING MY OMNIPOD 5 PUMP TO TRY TO BRING MY BLOOD SUGAR DOWN, WHICH WAS OVER 400 AT THIS POINT. I WAS ALSO GIVEN CORRECTIVE INSULIN IN THE IV TO BRING DOWN SUGAR. IT WASN'T TILL 9AM OR SO THAT MY SUGARS WERE BACK IN RANGE, AND AT THIS POINT, MY DEXCOM SENSOR WAS FINALLY FUNCTIONING AGAIN AND I WAS CALIBRATING IT USING THE READINGS I WAS GETTING FROM THE NURSES DOING FINGER-STICKS. I NOT ONLY INCURRED A $150 BILL FOR THE ER (EMERGENCY ROOM) STAY, BUT HAD TO CALL OFF WORK THAT MONDAY, SO THAT WAS A FULL DAY OF PAY MISSED. EXTREMELY UPSETTING AND DESTABILIZING TO HAVE THE TECHNOLOGY THAT IS SUPPOSED TO HELP KEEP YOU HEALTHY SUDDENLY GO COMPLETELY HAYWIRE AND GIVING YOU WILDLY FALSE AND DANGEROUS READINGS!! I JUST SPOKE WITH DEXCOM TECH SUPPORT ON THE PHONE, AND ALL THEY OFFERED WAS A REPLACEMENT OF THE ACTUAL NO SENSOR. JUST DOWNPLAYING THE URGENCY OF THE SITUATION, AND THE TOTAL TECHNICAL MALFUNCTION OF THEIR PRODUCT, WHICH LANDED ME IN THE ER, NOR THE LOSS OF MONEY I INCURRED DUE TO THEIR PRODUCT'S FAILING. THEY SIMPLY REMINDED ME THAT I SHOULD ONLY BASE MY MEDICAL DECISIONS OFF OF A GLUCOMETER, AND NOT THEIR SENSOR READINGS.... TRYING TO CLEAR THEMSELVES OF ANY LIABILITY FOR THEIR FAILURE. NO SORT OF FINANCIAL COMPENSATION FOR THE TRAUMATIC SITUATION OR FINANCIAL LOSS WAS OFFERED IN ANY WAY. I'VE GENERALLY HAD A LARGELY GOOD EXPERIENCE WITH DEXCOM UP TILL NOW, HAVE BEEN USING IT FOR ABOUT A YEAR OR SO. BUT THIS WHOLE SITUATION IS INCREDIBLY FRUSTRATING AND UPSETTING, AND DEXCOM'S TRYING TO JUST PASS IT OFF AS NO BIG DEAL IS ABSOLUTELY INFURIATING!
Report #76 - 3004753838-2025-272004 CRITICAL
View on MAUDE
Date of Event 2025-08-24
Patient Gender Male
Patient Age 80 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6)2025. ON (B)(6)2025, IT WAS REPORTED THAT AT AROUND 4PM, THE PATIENT WAS WITH HIS WIFE AT THE PARK AND ON THEIR WAY HOME, WHILE THE WIFE WAS DRIVING, THE PATIENT COMPLAINED THAT HE WAS SHAKY, AND LATER ON HAD A SEIZURE AND HE PASSED OUT. THE CGM WAS READING 368 AT THE TIME HE PASSED OUT AND THERE WAS NO BG TAKEN. WIFE CALLED 911 AND WHEN THEY ARRIVED, THEY TOOK A BG READING WHICH WAS 22 MG/DL WHILE THE CGM WAS 368 MG/DL. THEY TREATED THE PT WITH IV GLUCOSE AND DROVE HIM TO THE EMERGENCY ROOM (ER). BY THE TIME THEY ARRIVED AT THE ER, THE BG WAS 140 MG/DL. WIFE DOES NOT RECALL THE MEDICATIONS GIVEN AT THE HOSPITAL. THE PT WOKE UP AFTER ROUGHLY 20 MINUTES AND THE NEXT DAY HE WAS DISCHARGED. HIS BG READING WAS 200 MG/DL BEFORE THEY SENT HIM HOME THE PATIENT FELT FINE AT THE TIME OF THE INTERACTION. NO OTHER DETAILS WERE DOCUMENTED. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR WHEN THE PATIENT PASSED OUT. THE REPORTED GLUCOSE VALUES FALL WITHIN THE E ZONE OF THE PARKES ERROR GRID WHEN CHECKED BY THE PARAMEDICS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #77 - 3004753838-2025-261470 CRITICAL
View on MAUDE
Date of Event 2025-08-24
Patient Gender Female
Patient Age 56 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS AND FALL WITH INJURIES. AT TAN UNSPECIFIED TIME OF THE EVENT THE CGM WAS READING 6.7 MMOL/L AND THE BLOOD GLUCOSE READING WAS 2.3 MMOL/L. AN AMBULANCE WAS CALLED AND THE PATIENT WAS TAKEN TO THE HOSPITAL. NO OTHER DETAILS WERE DOCUMENTED. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #78 - 3004753838-2025-259760 CRITICAL
View on MAUDE
Date of Event 2025-08-24
Patient Gender Female
Patient Age 69 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. THE SENSOR WAS INSERTED INTO HE ABDOMEN. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT WAS ALLEGING THAT HER APP WAS NOT ALERTING BASED ON HER SETTINGS. HER LOW ALERT WAS SET TO 85 MG/DL BUT IT WAS NOT ALERTING HER AND THE URGENT LOW DID NOT WORK EITHER. IT ONLY ALERTS HER IF THE READING WAS 44 MG/DL WHICH WAS A VERY CRITICAL LEVEL. ON (B)(6) 2025 AT AROUND 1:30AM TO 2:00AM, THE PATIENT WAS AWAKEN BY A LOW READING ALARM (44 MG/DL) BY HER DEXCOM. PATIENT WENT TO THE BATHROOM, BUT SHE PASSED OUT AND HIT HER HEAD ON THE EDGE OF HER TUB. THE PATIENT WAS LIVING ALONE AND WAS LIVING IN A SMALL APARTMENT. WHEN SHE WOKE UP (UNSPECIFIED TIME, PATIENT DOES NOT RECALL HOW LONG SHE WAS UNCONSCIOUS), SHE FELT DIZZY AND HER LEGS WERE SHAKING AND SHE WAS DISCOMBOBULATED BUT SHE MANAGED TO TREAT WITH 2 GLASSES OF LEMONADE AND HEATED FOOD IN THE OVEN. AFTER THAT, SHE WENT BACK TO SLEEP AND NEVER SEEK MEDICAL ATTENTION OR CALLED 911. PATIENT DOES NOT RECALL WHAT HER READING WAS AFTER THE EVENT. DURING THE CALL LAST (B)(6) 2025 THE PATIENT STILL DID CONSULT ANY MEDICAL HELP AND SHE STILL HAS SOME BRUISING ON HER FACE AND HER NECK WAS HURTING. NO OTHER DETAILS WERE DOCUMENTED. DATA HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #79 - 3004753838-2025-253693 CRITICAL
View on MAUDE
Date of Event 2025-08-24
Patient Gender Female
Patient Age 69 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SENSOR FAILURE AFTER WHICH THE EXPERIENCED A HYPOGLYCEMIC EVENT. THE DAY OF THE EVENT THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS AND WOKE UP ON THE FLOOR AT 03:00AM, AFTER HAVING GONE TO BED AT 10:30PM. WHEN THE PATIENT CHECKED THEIR CGM DEVICE, IT WAS SHOWING A SENSOR FAILURE. THE PATIENT INSERTED A NEW SENSOR AND, TOGETHER WITH A FINGERSTICK, CONFIRMED THEY HAD A HYPOGLYCEMIC EVENT. THE PATIENT TOOK 2 PACKETS OF GLUCOSE GEL AND SOME APPLE JUICE. THE PATIENT NOTED THAT SHE HAD SEVERE BRUISES, AND SHE WAS IN GREAT PAIN ON BOTH HER SHOULDER AND NECK. THE PATIENT WENT TO THE HOSPITAL FOR THIS AND ARRIVED AROUND 02:00PM. AFTER CHANGING HOSPITALS A FEW TIMES, AN MRI WAS MADE, AND THE PATIENT WAS DIAGNOSED WITH COSTOCHONDRITIS NECK SPRAIN OR STRAIN. THE PATIENT WAS GIVEN MORPHINE FOR THE PAIN AND WAS PRESCRIBED OXYCODONE 5MG AND METHOCARBAMOL ROBAXIN. THE PATIENT WAS 2 WEEKS¿ BED REST AND 2 MONTHS OF NO PHYSICAL ACTIVITY. THE PATIENT LEFT THE HOSPITAL THE NEXT MORNING AT 03:00AM. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. PERFORMANCE DATA WAS REVIEWED. THE ALLEGATION WAS CONFIRMED DUE TO FINDINGS OF WEARABLE FAILURE. THE PROBABLE CAUSE WAS DETERMINED TO BE LOW COUNT ABERRATION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Report #80 - 3004753838-2025-253847 CRITICAL
View on MAUDE
Date of Event 2025-08-24
Patient Gender Female
Patient Age 64 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2025. ACCORDING TO THE PATIENT, ON (B)(6) 2025, THE PATIENT SUDDENLY PASSED OUT. SHE SAID SHE HAD HYPOGLYCEMIA. THE INSIDE OF HER MOUTH WAS BLEEDING BECAUSE HER HEAD HIT THE CENTER CONSOLE OF THE CAR. THE PATIENT¿S DAUGHTER GAVE THE PATIENT APPLE JUICE ONLY, NO OTHER MEDICATIONS. THE PATIENT DID NOT SEEK ANY HIGHER LEVEL OF CARE AND DID NOT GO TO ANY HOSPITAL. THE PATIENT JUST RESTED FOR A WHILE AND THEN WENT HOME WHEN SHE WAS STABLE. AT THE TIME OF THE REPORT, THE PATIENT WAS STABLE AND RECOVERED. PERFORMANCE DATA WAS REVIEWED. A NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED VIA DATA. HOWEVER, IT WAS FOUND THAT NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE UNDER AN HOUR OCCURRED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED.
Report #81 - 3004753838-2025-271370 CRITICAL
View on MAUDE
Date of Event 2025-08-23
Patient Gender Female
Patient Age 69 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4) DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. ON (B)(6) 2025, THE PATIENT EXPERIENCED A DEVICE-RELATED ISSUE IN WHICH NO ALERTS OR ALARMS WERE RECEIVED. AT APPROXIMATELY 6:00 PM, THE PATIENT REPLACED THE WEARABLE DEVICE AND CONFIRMED THAT IT HAD PAIRED AND WAS WARMING UP. HOWEVER, SHE DID NOT VERIFY ON-SCREEN THAT THE WARM-UP PROCESS HAD COMPLETED BEFORE ATTENDING A SOCIAL EVENT INVOLVING DANCING FROM 6:00 PM TO 10:00 PM. NO ALERTS OR ALARMS OCCURRED DURING THIS TIME, AND THE PATIENT DID NOT CHECK THE RECEIVER, ASSUMING IT WAS FUNCTIONING PROPERLY. AT APPROXIMATELY 10:30 PM, THE PATIENT RETURNED HOME AND WENT TO BED. ON (B)(6) 2025, AT AROUND 3:00 AM, SHE AWOKE ON THE FLOOR, HAVING EXPERIENCED A HYPOGLYCEMIC EPISODE THAT LED TO LOSS OF CONSCIOUSNESS AND A FALL. UPON REGAINING CONSCIOUSNESS, SHE SELF-TREATED WITH TWO GLUCOSE GEL PACKETS, ORANGES, AND APPLE JUICE. NO BLOOD GLUCOSE (BG) OR CONTINUOUS GLUCOSE MONITORING (CGM) VALUES WERE REPORTED, AND NO RECEIVER DISPLAY MESSAGES WERE PROVIDED. FOLLOWING THE FALL, THE PATIENT REPORTED BRUISING AND PAIN IN THE NECK AND SHOULDER AREA. AT 2:00 PM ON (B)(6) 2025, SHE PRESENTED TO THE EMERGENCY ROOM FOR EVALUATION. DIAGNOSTIC IMAGING, INCLUDING SCANS AND MRI, WAS PERFORMED. SHE WAS TREATED WITH MORPHINE FOR PAIN MANAGEMENT. THE HEALTHCARE PROVIDER DIAGNOSED COSTOCHONDRITIS AND A NECK SPRAIN/STRAIN. THE PATIENT WAS PRESCRIBED ORAL PAIN MEDICATIONS: OXYCODONE 5 MG (THREE TIMES DAILY) AND METHOCARBAMOL (ROBAXIN) 500 MG (THREE TIMES DAILY). THE PATIENT WAS DISCHARGED AT 3:00 AM ON (B)(6) 2025. AS OF THE REPORT DATE, THE PATIENT WAS RESTING AT HOME. SHE HAD COMPLETED THE OXYCODONE PRESCRIPTION AND PLANNED TO CONTINUE METHOCARBAMOL THROUGH (B)(6) 2025, AS DIRECTED. PRODUCT HAS BEEN RETURNED AND THE INVESTIGATION IS BEING REVIEWED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER THE REVIEW IS COMPLETE. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #82 - 3004753838-2025-250793 CRITICAL
View on MAUDE
Date of Event 2025-08-23
Patient Gender Female
Patient Age 13 YR
Device DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
IT WAS REPORTED THAT A SIGNAL LOSS OCCURRED. ACCORDING TO THE PATIENT¿S PARENT, ON (B)(6) 2025, WHILE VOLUNTEERING AT A 5K TRIATHLON, THE PATIENT STARTED SCREAMING TO HER MOTHER THAT SHE HAD A BLACK SPOT IN HER VISION. THE PATIENT THEN STUMBLED BACKWARDS, COLLAPSED, WAS UNRESPONSIVE, AND STARTED CONVULSING. EMERGENCY MEDICAL SERVICES (EMS) WAS CALLED AND ONCE THEY ARRIVED, THE PATIENT¿S BLOOD GLUCOSE (BG) METER READING WAS 45 MG/DL WHILE THE CONTINUOUS GLUCOSE MONITOR (CGM) WAS IN A SIGNAL LOSS STATE. IT WAS NOT NOTED HOW LONG THE CGM DEVICE HAD BEEN IN A SIGNAL LOSS STATE PRIOR TO THIS. THE PATIENT WAS TREATED WITH GLUCOSE GEL AND TRANSPORTED TO THE EMERGENCY ROOM (ER). AT THE ER, THE PATIENT¿S BG METER READING WAS 65 MG/DL AND THE CGM RESUMED PROVIDING VALUES BY THIS TIME AND WAS READING 68 MG/DL. THE PATIENT WAS GIVEN TYLENOL AND A BREAKFAST TRAY. BLOODWORK WAS ALSO DRAWN. THE PATIENT WAS DISCHARGED FROM THE ER AFTER APPROXIMATELY 40 MINUTES. THE PATIENT WAS ¿STABLE¿ AT THE TIME OF REPORT. DATA HAS BEEN REQUESTED BUT IS PENDING EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #83 - 3004753838-2025-248617 CRITICAL
View on MAUDE
Date of Event 2025-08-23
Patient Gender Male
Patient Age 60 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT REPORTED LOSING CONSCIOUSNESS WITHOUT EXPERIENCING ANY PRIOR SYMPTOMS WITH A CGM VALUE OF 80 MG/DL. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL VIA EMS, WHERE A BG READING OF 19 MG/DL WAS TAKEN. PARAMEDICS TREATED THE PATIENT WITH IV DEXTROSE AND GLUCAGON. WHILE AT THE HOSPITAL THE PATIENT WAS UNCONSCIOUS FOR TWO HOURS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER THREE HOURS AND REPORTED FEELING FINE WITH A BG READING OF 116 MG/DL. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALLS WITHIN THE B ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #84 - 3004753838-2025-248831 CRITICAL
View on MAUDE
Date of Event 2025-08-23
Patient Gender Male
Patient Age 38 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. ON APPROXIMATELY (B)(6) 2025, THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS. THE PATIENT REPORTEDLY DID NOT RECEIVER ALERTS ON HIS PHONE. DUE TO A FALL THE PATIENT EXPERIENCED BRUISING AND CUTS ALL OF THEIR BODY. THE PATIENT WAS BROUGHT TO THE HOSPITAL. THE PATIENT WAS TREATED WITH A JUBIN GLUCOSE GEL AND THEIR WOUNDS WERE TREATED. THE PATIENT HAD PAIN AFTER THE EVENT AND WAS TAKING ¿HYPOPROFEHM¿ 500MG (MOST LIKELY IBUPROFEN) DAILY FOR THIS. NO FURTHER TREATMENT WAS REPORTED TO BE NEEDED BUT IT WAS NOT KNOWN HOW MUCH TIME THE PATIENT SPENT AT THE HOSPITAL. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #85 - 3004753838-2025-246974 CRITICAL
View on MAUDE
Date of Event 2025-08-23
Patient Gender Male
Patient Age 34 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS AND WAS TAKEN TO THE HOSPITAL VIA AMBULANCE. WHILE AT THE HOSPITAL, THE PATIENT WAS TREATED WITH GLUCOSE RAPID GELS AND DISCHARGED AFTER FOUR HOURS. THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. AT THE TIME OF THE REPORT, THE PATIENT HAD RECOVERED FROM THE HYPOGLYCEMIC EVENT. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS.
Report #86 - 3004753838-2025-249840 CRITICAL
View on MAUDE
Date of Event 2025-08-22
Patient Gender Female
Patient Age 33 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025, WHICH IS OFF-LABEL USAGE OF THE DEVICE. ON (B)(6) 2025, IT WAS REPORTED THAT IN THE MORNING OF THE PATIENT'S RETURN FROM VACATION, THE PATIENT ARRIVED AT THE AIRPORT AND PROCEEDED HOME. SHORTLY AFTER ARRIVING, SHE FELL ASLEEP. DURING THIS TIME, SHE EXPERIENCED A SEIZURE. HER BOYFRIEND NOTICED THAT THE INSULIN PUMP WAS NOT DISPLAYING ANY READINGS, PROMPTING THE DISPATCH OF EMERGENCY MEDICAL PERSONNEL TO THEIR RESIDENCE. UPON ARRIVAL, PARAMEDICS CONFIRMED THAT THE INSULIN PUMP WAS NOT REGISTERING ANY DATA. A BLOOD GLUCOSE TEST REVEALED A LEVEL OF 55 MG/DL, INDICATING HYPOGLYCEMIA. ADDITIONALLY, THE PATIENT'S DEXCOM DEVICE WAS ALSO FAILING TO PROVIDE READINGS. THE PARAMEDICS, ACCOMPANIED BY HER BOYFRIEND, TRANSPORTED THE PATIENT TO THE EMERGENCY ROOM. THERE, THE ATTENDING PHYSICIAN ADMINISTERED AN INSULIN INJECTION (NO INFORMATION WHY THE PATIENT WAS TREATED WITH INSULIN DURING HYPOGLYCEMIC EVENT) AND PERFORMED BOTH A CT SCAN AND AN X-RAY. THE PATIENT WAS HOSPITALIZED FROM SATURDAY (B)(6) TO SUNDAY MORNING, (B)(6). SHE WAS DISCHARGED AT APPROXIMATELY 8:00 AM AND RETURNED HOME AROUND 10:00 AM. AT THE TIME OF THE REPORT, THE PATIENT CONTINUED TO EXPERIENCE FATIGUE AND WAS FOCUSING ON REST AND RECOVERY. IT WAS REPORTED THAT NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE OCCURRED. DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS NOT CONFIRMED VIA DATA. HOWEVER, IT WAS FOUND THAT NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE UNDER AN HOUR OCCURRED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #87 - 3004753838-2025-248731 CRITICAL
View on MAUDE
Date of Event 2025-08-22
Patient Gender Female
Patient Age 54 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA, SEIZURE AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025 AT APPROXIMATELY 12¿1 AM CST, THE PATIENT WAS OBSERVED SLEEPING AND CONVULSING. THE PATIENT USES THE INSULET OMNIPOD5 IN A MODIFIED CLOSED-LOOP SYSTEM. THE PATIENT'S MOTHER ATTEMPTED TO WAKE HER BUT FOUND HER UNRESPONSIVE AND CALLED 911. UPON WAKING, THE PATIENT REPORTED FEELING DISORIENTED, SWEATY, AND COLD. BOTH THE RECEIVER AND MOBILE DEVICE DISPLAYED A READING OF 61 MG/DL. ALTHOUGH NO FINGERSTICK WAS PERFORMED AT THAT TIME, THE PATIENT FELT HER GLUCOSE LEVEL WAS LOWER THAN THE ESTIMATED GLUCOSE VALUE (EGV). SHE CONSUMED ORANGE JUICE. APPROXIMATELY 20¿30 MINUTES LATER, EMTS ARRIVED. THE CGM SHOWED 120 MG/DL, WHILE THE FINGERSTICK READING WAS 69 MG/DL. IN THE AMBULANCE, THE PATIENT¿S BLOOD GLUCOSE WAS 72 MG/DL (THE DEXCOM SENSOR HAD ALREADY BEEN REMOVED PRIOR TO DEPARTURE). EMTS ADMINISTERED GLUCOSE GEL. UPON ARRIVAL AT THE HOSPITAL AT 1:31 AM CST, A CT SCAN WAS PERFORMED, AND GLUCOSE WAS ADMINISTERED VIA IV. THE PATIENT WAS ALSO GIVEN CARBOHYDRATES. BEFORE DISCHARGE AT 5:00 AM, HER BLOOD GLUCOSE WAS 140 MG/DL. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR BEFORE THE EMT ARRIVED AND WHEN THE PATIENT WAS IN THE HOSPITAL. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID WAS TAKEN WHEN EMT ARRIVED. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #88 - 3004753838-2025-251964 CRITICAL
View on MAUDE
Date of Event 2025-08-21
Patient Gender Male
Patient Age 71 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. ON (B)(6) 2025, THE REPORTER RETURNED HOME FROM THE STORE AND FOUND THE PATIENT SWEATING ON THE COUCH. THE PATIENT¿S CGM READING WAS 40 MG/DL, BUT THE DEXCOM RECEIVER DID NOT ALERT HIM TO THE HYPOGLYCEMIC STATE, DESPITE THE LOW ALERT THRESHOLD BEING SET AT 60 MG/DL. EMERGENCY MEDICAL SERVICE (EMS) WAS CALLED, AND THE PATIENT LOST CONSCIOUSNESS AS THEY ARRIVED. A BLOOD GLUCOSE METER READING TAKEN AT THE SCENE WAS 20 MG/DL. THE PATIENT WAS TREATED WITH INTRAVENOUS ¿SUGAR WATER¿ AND REGAINED CONSCIOUSNESS AFTER APPROXIMATELY 15 MINUTES. BEFORE EMS DEPARTED, THE PATIENT¿S BG METER READING WAS 120 MG/DL. THE PATIENT REMAINED AT HOME AND WAS REPORTED TO BE ¿FINE¿ AT THE TIME OF THE REPORT. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. PROBLEM COULD NOT BE CONFIRMED AND PROBABLE CAUSE CANNOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #89 - 3004753838-2025-249961 CRITICAL
View on MAUDE
Date of Event 2025-08-21
Patient Gender Male
Patient Age 73 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT WAS GETTING 63 AND 73 MG/DL ON THE MOBILE DEVICE. THE PATIENT DID NOT HAVE FINGER STICKS TO CHECK A MANUAL BG. THE PATIENT WAS FOUND OUT OF IT WITH HIS HEAD DOWN AND THEIR CALLED PARAMEDICS. THE TIME AT WHICH THE FAMILY DISCOVERED THE PATIENT WAS NOT SPECIFIED. HOWEVER, ONE OF THE PATIENT¿S DAUGHTERS REPORTED THAT FOR TWO DAYS, THE CGM READINGS WERE CONSISTENTLY AT 80 MG/DL AND BELOW. UPON ARRIVAL, PARAMEDICS PERFORMED A FINGER STICK TEST WHICH SHOWED A BLOOD GLUCOSE LEVEL OF 500 MG/DL, WHILE THE MOBILE DEVICE STILL DISPLAYED 80 MG/DL. THE PATIENT WAS TAKEN TO THE HOSPITAL AND WAS IN CARDIAC ARREST. AT THE HOSPITAL, AFTER THE PATIENT WAS REVIVED, A BLOOD GLUCOSE READING OF READING OF 1500 MG/DL WAS RECORDED. THE REPORTER WAS UNSURE WHETHER THIS READING WAS OBTAINED VIA FINGER PRICK OR BLOOD WORK. NO CGM READING WAS MENTIONED AT THAT TIME. THE PATIENT WAS TREATED WITH INSULIN DRIP. THE PATIENT WAS REPORTEDLY REVIVED TO LIFE BUT STILL IN A COMA 9 DAYS AFTER THE EVENT. FOLLOW UP CONTACT WAS MADE WITH THE REPORTER ON 09/05/2025. THE DAUGHTER REPORTED BEING ON THE WAY TO THE HOSPITAL AT THAT TIME TO WITHDRAW CARE AND REMOVE THE PATIENT FROM LIFE SUPPORT. NO OTHER INFORMATION IS AVAILABLE. NO PRODUCT WAS PROVIDED FOR EVALUATION. DATA HAS BEEN REQUESTED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION.
Report #90 - 3004753838-2025-251888 CRITICAL
View on MAUDE
Date of Event 2025-08-20
Patient Gender Male
Patient Age 68 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. H6: MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. | IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FAILURE TO ALERT AFTER WHICH THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT. THE DAY OF THE EVENT THE PATIENT WAS SLEEPING AND THEIR SUN WAS UNABLE TO WAKE THEM UP AND THEY HAD LOST CONSCIOUSNESS. THE CGM READING WAS 66 MG/DL, AND WHEN A FINGERSTICK WAS TAKEN THE BLOOD GLUCOSE READING WAS LOW (NO SPECIFIC READING REPORTED). THE PATIENT WAS TREATED BY THEIR SON WITH SUGAR. THE PATIENT REGAINED CONSCIOUSNESS AND DECLINED ANY FURTHER ASSISTANCE. NO FURTHER TREATMENT WAS REPORTED TO BE NEEDED. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. DATA HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Report #91 - 3004753838-2025-248794 CRITICAL
View on MAUDE
Date of Event 2025-08-20
Patient Gender Female
Patient Age 54 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON WEDNESDAY, (B)(6) 2025, AT APPROXIMATELY 11:00 PM CST, THE PATIENT WAS FOUND BY HER MOTHER TO BE DRENCHED IN SWEAT WHILE ASLEEP. HER MOTHER ATTEMPTED TO WAKE HER BUT FOUND HER UNRESPONSIVE. AT THE TIME OF THE EVENT, THE DEXCOM READING WAS NOT CHECKED, ALTHOUGH THE DEVICE HAD BEEN FUNCTIONING NORMALLY PRIOR TO THE INCIDENT. 911 WAS CALLED, AND UPON ARRIVAL, EMTS PERFORMED A FINGERSTICK WHICH SHOWED A BLOOD GLUCOSE LEVEL OF 32 MG/DL. THE PATIENT REMAINED UNCONSCIOUS THROUGHOUT THE EPISODE AND WAS UNAWARE OF THE DEXCOM READINGS DURING THE EVENT. HER MOTHER WAS ALSO UNABLE TO CHECK THE DEXCOM RECEIVER OR MOBILE DEVICE. THE PATIENT WAS TRANSPORTED TO THE SAME HOSPITAL AS IN THE PREVIOUS INCIDENT. HER MOTHER WAS NOT PRESENT DURING THE HOSPITAL STAY AND WAS UNAWARE OF THE SPECIFIC INTERVENTIONS OR MEDICATIONS ADMINISTERED. THE PATIENT STABILIZED AND WAS DISCHARGED AT APPROXIMATELY 2:00 AM ON (B)(6) 2025. SHE DOES NOT RECALL HER GLUCOSE LEVEL AT DISCHARGE, AS HER PHONE WAS NOT WITH HER AT THE TIME. AT THE TIME OF THE REPORT, THE PATIENT WAS FINE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #92 - 3004753838-2025-245290 CRITICAL
View on MAUDE
Date of Event 2025-08-20
Patient Gender Male
Patient Age 85 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE EVENT THE PATIENT EXPERIENCED SWEATING, WAS VERY PALE, HAD SLURRY SPEECH AND LOST CONSCIOUSNESS. IT WAS UNKNOWN HOW MUCH TIME THE PATIENT WAS UNCONSCIOUS FOR BY WHEN THEY WERE FOUND BY THEIR DAUGHTER AND A FINGERSTICK WAS TAKEN THE CGM READING WAS 140 MG/DL, AND THE BLOOD GLUCOSE READING WAS 50 MG/DL. THE PATIENT WAS TREATED WITH 5 SPOONS OF HONEY. NO FURTHER TREATMENT WAS REPORTED TO BE NEEDED. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #93 - 3004753838-2025-265201 CRITICAL
View on MAUDE
Date of Event 2025-08-19
Patient Gender Male
Patient Age 58 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. H6: MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. H6: HEALTH EFFECT - CLINICAL CODE - 4461 -RESPIRATORY ARREST. | IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. THE SENSOR WAS INSERTED INTO THE UPPER BUTTOCKS, WHICH IS OFF-LABEL USAGE OF THE DEVICE, ON (B)(6) 2025. ACCORDING TO THE PATIENT¿S SPOUSE, ON (B)(6) 2025, THE PATIENT HAD SIGNIFICANTLY ELEVATED BLOOD GLUCOSE LEVELS THE DAY PRIOR, WHILE OUT OF TOWN, WITH READINGS REACHING APPROXIMATELY 300 MG/DL. HE FLEW BACK HOME ON MONDAY AFTERNOON. ON THE EVENING OF HIS RETURN, THE PATIENT FELL OFF THE BED. THE PATIENT'S DAUGHTER RESPONDED IMMEDIATELY BY RETRIEVING THE PATIENT¿S INSULIN. THE PATIENT THEN SELF-ADMINISTERED INSULIN, INJECTING IT INTO HIS ABDOMEN. SHORTLY AFTER THE INJECTION, THE PATIENT CEASED TO BREATHE. AN AMBULANCE WAS CALLED. UPON ARRIVAL, PARAMEDICS INITIATED CARDIOPULMONARY RESUSCITATION (CPR). CPR WAS PERFORMED FOR APPROXIMATELY 1 HOUR AND 30 MINUTES. FOLLOWING THIS PROLONGED RESUSCITATION EFFORT, THE PATIENT¿S PULSE WAS SUCCESSFULLY RESTORED. THE PATIENT WAS STABILIZED AND PULSE RETURNED POST-CPR. THIS HAD CAUSED THE PATIENT TO BE ADMITTED INTO THE INTENSIVE CARE UNIT FOR DAYS. THE ALLEGATIONS AGAINST DEXCOM WERE UNCLEAR. AT THE TIME THE PATIENT DEVELOPED SYMPTOMS, THE CGM DISPLAYED A READING OF 40 MG/DL, WHILE A BLOOD GLUCOSE (BG) TEST SHOWED 39 MG/DL. AT THE TIME OF THE REPORT THE PATIENT WAS STILL HOSPITALIZED. DATA HAS BEEN REQUESTED BUT IS PENDING EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #94 - 3004753838-2025-245534 CRITICAL
View on MAUDE
Date of Event 2025-08-19
Patient Gender Female
Patient Age 70 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. ACCORDING TO THE PATIENT, ON (B)(6) 2025, THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS. THE CGM DEVICE WAS NOT CHECKED AT ANY TIME DURING THE EVENT, AND IT WAS NOT KNOWN WHAT THE CGM READING WAS, AND IF THERE WERE CGM READINGS DURING THE EVENT. AT AROUND 2:30AM, THE PATIENT¿S HUSBAND CHECKED ON THE PATIENT WHILE SHE WAS SLEEPING AND FOUND THAT SHE WAS UNCONSCIOUS AND PASSED OUT. THE PATIENT DOES NOT KNOW IF THEIR HUSBAND CHECKED THE CGM READING BUT THE HUSBAND CALLED 911. WHEN THE PARAMEDICS ARRIVED, THE PATIENT WAS BROUGHT TO THE HOSPITAL. WHEN THE PATIENT WAS CONSCIOUS SHE WAS INFORMED THAT HER BLOOD GLUCOSE READING WAS BELOW 30 MG/DL. THE CGM DEVICE DID NOT ALERT DURING THE EVENT FOR A LOW CGM READING. THE PATIENT SAID SHE WAS WEARING AN OXYGEN MASK WHEN SHE WAS IN THE EMERGENCY ROOM AND THEY HAD TO PUT 2 DIFFERENT INTRAVENOUS LINES. THE PATIENT RECOVERED AND WAS SENT HOME ON THE SAME DAY. SHE WAS ADVISED TO TAKE TYLENOL EXTRA STRENGTH (2 TABLETS CONSISTING OF 1000 MG EACH) OVER THE COURSE OF 6 HOURS IF SHE FEELS PAIN (PATIENT HAD A BRUISE AND PAIN FROM THE APPARENTLY PERFORMED CPR). THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION AND PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.
Report #95 - 3004753838-2025-241499 CRITICAL
View on MAUDE
Date of Event 2025-08-19
Patient Gender Female
Patient Age 55 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT SENSOR FAILURE OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HYPOGLYCEMIC EPISODE AFTER THE SENSOR FAILED AND STOPPED WORKING. THE PATIENT WAS UNABLE TO MONITOR GLUCOSE LEVELS AND LOST CONSCIOUSNESS AT HOME. THE PATIENT'S BROTHER IMMEDIATELY CALLED PARAMEDICS. UPON ARRIVAL, PARAMEDICS ADMINISTERED ORANGE JUICE ORALLY. THE PATIENT REGAINED CONSCIOUSNESS SHORTLY AFTER. THE PATIENT REFUSED TRANSPORT TO THE HOSPITAL AND OPTED TO REMAIN AT HOME. PARAMEDICS DID NOT PERFORM A GLUCOSE TEST TO CHECK THE PATIENT'S BLOOD GLUCOSE LEVEL DURING THE INTERVENTION. THE PATIENT WAS FEELING FINE AT THE TIME OF THE REPORT. DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS CONFIRMED VIA DATA AS A SENSOR FAILURE DURING WARM-UP. THE PROBABLE CAUSE WAS DETERMINED TO BE PROGRESSIVE SENSOR DECLINE. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #96 - 3004753838-2025-241593 CRITICAL
View on MAUDE
Date of Event 2025-08-19
Patient Gender Female
Patient Age 52 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON THE SAME DAY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA OF 18 MG/DL WHILE SLEEPING. SHE WAS SWEATING AND EXPERIENCED LOSS OF CONSCIOUSNESS. THE HUSBAND TREATED THE PATIENT WITH GLUCAGON (GLUCAGEN HYPOKIT 1MG, TWO DOSES.) AT THE TIME OF THE REPORT THE PATIENT WAS FINE AND THE BG READING WAS 60 MG/DL. DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS NOT CONFIRMED VIA DATA. HOWEVER, IT WAS FOUND THAT NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE UNDER AN HOUR OCCURRED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #97 - 3004753838-2025-250550 CRITICAL
View on MAUDE
Date of Event 2025-08-18
Patient Gender N/A
Patient Age N/A
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ACCORDING TO THE PATIENT, ON (B)(6) 2025, SHE BEGAN EXPERIENCING INACCURATE READINGS ON THE CGM. THE PATIENT DID NOT EXPERIENCE ANY MEDICAL INTERVENTION OR SYMPTOMS PRIOR TO (B)(6) 2025. ON (B)(6) 2025, THE PATIENT SUDDENLY BEGAN SWEATING, CRIED OUT, ¿HELP ME, HELP ME.¿ AND BECAME UNRESPONSIVE. HER BOYFRIEND PROMPTLY CONTACTED EMERGENCY SERVICES AFTER DISCOVERING THAT HER BLOOD GLUCOSE LEVEL HAD DROPPED TO 25 MG/DL. AT THAT TIME, THE PATIENT DID NOT PROVIDE ANY INFORMATION REGARDING THE READINGS ON HER CGM AND CANNOT CONFIRM IF SHE RECEIVED AN ALARM OR ALERT AT THIS TIME. WHILE IN THE AMBULANCE, THE PATIENT WAS UNCONSCIOUS AND IS UNABLE TO RECALL THE EVENTS DURING TRANSPORT. UPON ARRIVAL AT THE HOSPITAL, THE PATIENT REGAINED CONSCIOUSNESS, AND HER BLOOD GLUCOSE LEVEL HAD INCREASED TO 72 MG/DL, AS CHECKED BY THE ATTENDING NURSE. THE NURSE ADMINISTERED ¿SUGAR WATER¿ TO ELEVATE THE PATIENT¿S BLOOD GLUCOSE, WHICH SPIKED TO APPROXIMATELY 300 MG/DL. HOWEVER, HER BG DROPPED AGAIN SHORTLY AFTERWARD, THOUGH THE PATIENT WAS UNABLE TO CONFIRM THE EXACT VALUE. TO HELP STABILIZE HER CONDITION, THE PATIENT CONSUMED A BOWL OF CEREAL, WHICH BROUGHT HER BLOOD SUGAR LEVEL BACK UP TO 147 MG/DL, CONFIRMED VIA FINGER STICK. THE PATIENT WAS UNABLE TO CONFIRM CGM VALUE AS IT WAS REMOVED BY THE NURSE AT THE HOSPITAL. AT AN UNSPECIFIED TIME OF THE EVENT THE CGM READING WAS 315 MG/DL AND THE BG READING WAS 240 MG/DL. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL A FEW HOURS LATER ON THE SAME DAY AND WAS STABLE. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE REPORTED GLUCOSE VALUES FALL WITHIN THE A ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #98 - 3004753838-2025-248869 CRITICAL
View on MAUDE
Date of Event 2025-08-18
Patient Gender Female
Patient Age 42 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON THE SAME DAY, IT WAS REPORTED THAT AT APPROXIMATELY 9:00 AM, THE PATIENT WAS FOUND UNRESPONSIVE WHILE ASLEEP AT HOME. SHE WAS EXPERIENCING A HYPOGLYCEMIC EPISODE. UPON DISCOVERING HER CONDITION, THE PATIENT'S FATHER DID NOT PERFORM A BLOOD GLUCOSE TEST BUT IMMEDIATELY TRANSPORTED HER TO THE HOSPITAL. SHE REMAINED UNCONSCIOUS DURING THE TRIP AND ARRIVED AT THE FACILITY AROUND 10:00 AM. UPON ARRIVAL, THE PATIENT REGAINED PARTIAL CONSCIOUSNESS WHILE ON A STRETCHER AND WAS PROMPTLY ADMITTED TO THE EMERGENCY ROOM (ER). A BLOOD GLUCOSE TEST WAS CONDUCTED BY THE ATTENDING NURSE USING A BG METER, REVEALING A CRITICALLY LOW READING OF 20 MG/DL. DURING THIS TIME, THE PATIENT WAS INTERMITTENTLY CONSCIOUS. ACCORDING TO THE PATIENT¿S RECOLLECTION, SHE WAS TREATED WITH SUGAR WATER, DEXTROSE (DCT) FLUIDS, AND GIVEN A CAN OF COCA-COLA. THESE INTERVENTIONS RESULTED IN AN ESTIMATED BG INCREASE TO 150 MG/DL, AFTER WHICH SHE GRADUALLY REGAINED FULL CONSCIOUSNESS. THE PATIENT REMAINED HOSPITALIZED FOR CONTINUED MONITORING UNTIL HER BLOOD SUGAR LEVELS STABILIZED. DURING HER STAY, HER INSULIN PEN WAS CHANGED FROM BASAGLAR TO TOUJEO. ALTHOUGH SHE CANNOT RECALL THE EXACT DURATION OF HER HOSPITALIZATION OR ALL THE DETAILS OF THE INCIDENT, SHE REPORTS THAT SHE IS CURRENTLY FEELING BETTER. DATA HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Report #99 - 3004753838-2025-246761 CRITICAL
View on MAUDE
Date of Event 2025-08-18
Patient Gender N/A
Patient Age N/A
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT BETWEEN 8:30 PM AND 9:00 PM, THE PATIENT HAD TUNNEL VISION 3 DAYS AFTER THE SENSOR WAS PUT ON THE ARM. THE PATIENT USES INSULET OP5 IN MODIFIED CLOSED LOOP. AT THAT MOMENT, SHE WASN¿T LOOKING AT HER "RECEIVER" OR MOBILE DEVICE. SHE GLUCOSE TABLETS AND LOST CONSCIOUSNESS. SHE COLLAPSED, HIT HER HEAD, AND EXPERIENCED A SEIZURE DUE. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM (ER) IN AN AMBULANCE. UPON ARRIVAL, SHE UNDERWENT A CT SCAN AND ROUTINE BLOOD TESTS WERE ALSO CONDUCTED. SHE RECEIVED IV FLUIDS FOR APPROXIMATELY 3¿4 HOURS. AT THE TIME, BOTH HER CGM AND BG METER READINGS WERE UNKNOWN. SHE WAS DISCHARGED AROUND 4:30 AM ON (B)(6) 2025, AFTER SPENDING ROUGHLY 8 HOURS IN THE HOSPITAL. SHE WAS DIAGNOSED WITH A MILD CONCUSSION AND HAD MINOR BRUISING ON HER TAILBONE FROM THE FALL. DURING THE CALL SHE HAD OCCASIONAL HEADACHES AND DIZZINESS AND SORENESS. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #100 - 3004753838-2025-247144 CRITICAL
View on MAUDE
Date of Event 2025-08-18
Patient Gender Female
Patient Age 56 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ABDOMEN. ON (B)(6) 2025, THE PATIENT WAS USING BOTH G7 APP AND RECEIVER, SHE DID NOT NOTICE "WEARABLE FAILURE" ALERT ON EITHER DEVICE. IT WAS REPORTED THAT AFTER A FEW MINUTES AFTER THE WEARABLE FAILED, SHE EXPERIENCED HYPOGLYCEMIA AND FELL UNCONSCIOUS. THE AMBULANCE WAS CALLED BY THE PATIENT'S HUSBAND. THE PATIENT WAS TREATED WITH IV MEDICATION DURING DRIVE TO HOSPITAL AND DURING HOSPITAL STAY. THE PATIENT FELT NUMBNESS IN HER EXTREMITIES FOR SOME TIME AFTER SHE WOKE UP, SHE WAS ADVISED TO STAY IN HOSPITAL OVERNIGHT. THE PATIENT DID NOT REMEMBER WHAT THE LAST CGM READING WAS PRIOR TO THE WEARABLE FAILURE. THE LAST CGM READING SHE REMEMBERS WAS AROUND 100 MG/DL. AT THE TIME OF THE REPORT THE PATIENT WAS RECOVERED. NO PRODUCT WAS PROVIDED FOR EVALUATION. DATA HAS BEEN REQUESTED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #101 - 3004753838-2025-245368 CRITICAL
View on MAUDE
Date of Event 2025-08-18
Patient Gender Female
Patient Age 29 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED FEELING LETHARGIC, HAD TROUBLE BREATHING AND FAINTED. IT WAS UNKNOWN HOW, BUT THE PATIENT WENT TO THE EMERGENCY ROOM AND WHEN A FINGERSTICK WAS TAKEN THE CGM READING WAS LOW, AND THE BLOOD GLUCOSE READING WAS 721 MG/DL. THE PATIENT WOULD HAVE EXPERIENCED ¿EARLY¿ DIABETIC KETOACIDOSIS. NO SPECIFIC TREATMENT WAS REPORTED, AND IT WAS UNKNOWN HOW MUCH TIME THE PATIENT STAYED AT THE HOSPITAL. NO OTHER DETAILS WERE DOCUMENTED AND ATTEMPTS TO CONTACT THE PATIENT FOR MORE INFORMATION WERE UNSUCCESSFUL. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALLS WITHIN THE B ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS AND LOSS OF CONSCIOUSNESS.
Report #102 - 3004753838-2025-242756 CRITICAL
View on MAUDE
Date of Event 2025-08-18
Patient Gender Female
Patient Age 29 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED FEELING LETHARGIC, HAD TROUBLE BREATHING AND FAINTED. IT WAS UNKNOWN HOW, BUT THE PATIENT WENT TO THE EMERGENCY ROOM AND WHEN A FINGERSTICK WAS TAKEN THE CGM READING WAS LOW, AND THE BLOOD GLUCOSE READING WAS 721 MG/DL. THE PATIENT WOULD HAVE EXPERIENCED ¿EARLY¿ DIABETIC KETOACIDOSIS. NO SPECIFIC TREATMENT WAS REPORTED, AND IT WAS UNKNOWN HOW MUCH TIME THE PATIENT STAYED AT THE HOSPITAL. NO OTHER DETAILS WERE DOCUMENTED AND ATTEMPTS TO CONTACT THE PATIENT FOR MORE INFORMATION WERE UNSUCCESSFUL. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALLS WITHIN THE B ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #103 - 3004753838-2025-243382 CRITICAL
View on MAUDE
Date of Event 2025-08-18
Patient Gender Female
Patient Age 21 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT REPORTED SYMPTOMS CONSISTENT WITH HYPOGLYCEMIA AND WAS TRANSPORTED TO THE HOSPITAL. UPON ARRIVAL, A MANUAL BLOOD GLUCOSE CHECK REVEALED A CRITICALLY LOW READING OF 19 MG/DL. AT THAT TIME, THE PATIENT¿S DEXCOM DEVICE WAS NOT PROVIDING ANY READINGS DUE TO A SENSOR ERROR. SHORTLY AFTER ARRIVAL, THE PATIENT LOST CONSCIOUSNESS FOR APPROXIMATELY 15 TO 20 MINUTES. A NURSE ADMINISTERED DEXTROSE 50% IV (D50 IV) TO TREAT SEVERE HYPOGLYCEMIA. UPON REGAINING CONSCIOUSNESS, THE PATIENT CONTINUED TO RECEIVE D50 IV TREATMENT, WITH A TOTAL OF AT LEAST 18 DOSES ADMINISTERED DURING THE HOSPITAL STAY. AT THE TIME OF REPORTING, THE PATIENT WAS FEELING BETTER AND WAS EXPECTED TO BE DISCHARGED ON (B)(6) 2025. DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS NOT CONFIRMED VIA DATA. HOWEVER, NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE UNDER AN HOUR WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #104 - 3004753838-2025-248586 CRITICAL
View on MAUDE
Date of Event 2025-08-17
Patient Gender Male
Patient Age 74 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. ACCORDING TO THE PATIENT, ON APPROXIMATELY (B)(6) 2025, THE PATIENT¿S WIFE FOUND HIM UNCONSCIOUS AT THE DINING TABLE. THE PATIENT REGAINED CONSCIOUSNESS ON HIS OWN, AS IT WAS REPORTED THE PATIENT¿S WIFE DID NOT ADMINISTER ANY MEDICATION OR TREATMENT TO HIM WHILE UNCONSCIOUS. ONCE THE PATIENT WAS AWAKE AND ABLE, THE PATIENT¿S WIFE TREATED HIM WITH UNSPECIFIED FOOD. THE PATIENT¿S CGM WAS READING LOW AT THIS TIME HOWEVER, THE PATIENT STATED THAT THE DEXCOM MOBILE APP DID NOT ALERT HIM TO HIS HYPOGLYCEMIC STATE. THE PATIENT DID NOT SEEK ASSISTANCE FROM A HIGHER LEVEL OF CARE. THE PATIENT WAS ¿STABLE¿ AT THE TIME OF REPORT. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #105 - 3004753838-2025-241291 CRITICAL
View on MAUDE
Date of Event 2025-08-17
Patient Gender Female
Patient Age 56 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON THE SAME DAY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED INACCURATE CGM VALUES. THE DAY OF THE EVENT AT 3:28PM, THE CGM READING WAS 240 MG/DL AND THE INSULIN PUMP ADMINISTERED 2.51 UNITS OF INSULIN. SHORTLY AFTER, THE PATIENT RECEIVED AN OCCLUSION ALARM, PROMPTING HER TO CHANGE BOTH THE SENSOR AND THE PUMP. AT 4:10PM, THE CGM READING WAS 255 MG/DL. THE PUMP DELIVERED 2.97 UNITS OF INSULIN. AT 7:50PM, WHILE TAKING A NAP, THE PATIENT RECEIVED A HIGH BLOOD GLUCOSE ALERT FROM THE PUMP. NO SYMPTOMS WERE FELT INITIALLY BUT SHE SUDDENLY LOST CONSCIOUSNESS. A FAMILY MEMBER CALLED AN AMBULANCE AND PERFORMED A FINGERSTICK AND THE BLOOD GLUCOSE READING WAS 24 MG/DL. THE PATIENT COULD NO LONGER REMEMBER THE CGM READING AT THAT TIME. THE PATIENT SAID THAT THE PUMP WAS JUST SHOWING "HIGH" AND SHE WASN'T ABLE TO TAKE NOTE OF THE EXACT CGM READING. THE PATIENT WAS GIVEN THREE SERVINGS OF APPLE JUICE AND A JELLY SANDWICH. DESPITE THESE INTERVENTIONS, HER BLOOD GLUCOSE DID NOT IMPROVE, AND THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM, WHERE SHE RECEIVED INTRAVENOUS GLUCOSE TREATMENT. THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION AND WAS DISCHARGED EARLY THE FOLLOWING MORNING. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. WHEN THE AMBULANCE CAME, THE REPORTED GLUCOSE VALUES FALL WITHIN THE E ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #106 - 3004753838-2025-240569 CRITICAL
View on MAUDE
Date of Event 2025-08-17
Patient Gender Male
Patient Age NA
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT A DEXCOM APP CRASH OCCURRED. THIS IS 2 OF 2 REPORTS OF MEDICAL INTERVENTION THAT OCCURRED TWO SEPARATE TIMES BUT WITH SIMILAR DETAIL. AN ANONYMOUS REPORT SUBMITTED TO THE APP STORE DESCRIBED SEVERE CONNECTIVITY ISSUES WITH THE APP. THE PATIENT REPORTED FREQUENT DISCONNECTIONS, WITH THE APP EITHER INDICATING THEY WERE OUT OF RANGE OR CLOSING UNEXPECTEDLY. AS A RESULT, THE PATIENT WAS UNABLE TO MONITOR GLUCOSE LEVELS IN REAL TIME. THE PATIENT STATED THAT GLUCOSE READINGS REMAINED UNAVAILABLE UNTIL PHYSICAL SYMPTOMS FEELING "FUNNY" AND SWEATY PROMPTED THEM TO RESTART THE APP. UPON REGAINING ACCESS, GLUCOSE LEVELS WERE OFTEN CRITICALLY LOW, IN THE 40¿50 MG/DL RANGE. THE PATIENT NOTED HAVING TO REPEATEDLY CLOSE AND REOPEN THE APP BEFORE READINGS APPEAR. ALARMINGLY, THE PATIENT REPORTED BEING FOUND ON THE FLOOR ¿A FEW TIMES¿ DUE TO EPISODES OF EXTREME HYPOGLYCEMIA. DUE DILIGENCE WAS NOT ATTEMPTED AS THE REPORTER'S DETAILS WERE NOT ABLE TO BE IDENTIFIED. NO DATA OR PRODUCT WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. THIS IS 2 OF 2 REPORTS OF MEDICAL INTERVENTION THAT OCCURRED TWO SEPARATE TIMES BUT WITH SIMILAR DETAILS. PLEASE SEE RELATED RECORDS (B)(4).
Report #107 - 3004753838-2025-243795 CRITICAL
View on MAUDE
Date of Event 2025-08-16
Patient Gender Female
Patient Age 36 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. THIS IS 4 OF 5 ALLEGATIONS OF INACCURACIES. THE PATIENT REPORTED 5 INSTANCES IN WHICH EACH EVENT HAS SIMILAR DETAILS BUT OCCURRED ON DIFFERENT EVENT DATES. ON (B)(6) 2025, THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS WHILE ATTENDING CLASS. THE CGM READING AT THE TIME OF THE EVENT WAS NOT DOCUMENTED. AN AMBULANCE WAS CALLED, AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS, A ¿BIG DOSE OF GLUCOSE,¿ AND NAUSEA MEDICATION. BASED ON THE TREATMENT PROVIDED, THE EVENT WAS DETERMINED TO BE A HYPOGLYCEMIC EPISODE. WHEN A FINGERSTICK BLOOD GLUCOSE READING WAS TAKEN (POSSIBLY AFTER TREATMENT) THE CGM READING DISPLAYED LOW, WHILE THE BG READING WAS 312 MG/DL, INDICATING A SIGNIFICANT DISCREPANCY. THE PATIENT WAS DISCHARGED THE SAME DAY, AND NO FURTHER MEDICAL EVALUATION OR INTERVENTION WAS DOCUMENTED. AT THE TIME OF REPORTING, THE PATIENT WAS STABLE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA., HYPERGLYCEMIA. AND LOSS OF CONSCIOUSNESS. THIS IS 1 OF 5 ALLEGATIONS OF INACCURACIES. THE PATIENT REPORTED 5 INSTANCES IN WHICH EACH EVENT HAS SIMILAR DETAILS BUT OCCURRED ON DIFFERENT EVENT DATES. PLEASE SEE RELATED RECORDS (B)(4).
Report #108 - 3004753838-2025-243875 CRITICAL
View on MAUDE
Date of Event 2025-08-16
Patient Gender Male
Patient Age 64 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA, SEIZURE AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ABDOMEN, WHICH IS OFF-LABEL USAGE OF THE DEVICE, ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT WHILE AT THE BEACH. CGM READINGS AT THE TIME WERE BETWEEN 80¿90 MG/DL; NO BLOOD GLUCOSE FINGER STICK VALUE WAS OBTAINED PRIOR TO THE EVENT. IT WAS NOT SPECIFIED WHETHER THE PATIENT EXHIBITED ANY SYMPTOMS LEADING UP TO THE EPISODE. BASED ON CGM VALUES, THE PATIENT CONSIDERED EATING AN APPLE BUT SUBSEQUENTLY LOST CONSCIOUSNESS AND EXPERIENCED A SEIZURE. DURING OR SURROUNDING THE SEIZURE, THE PATIENT¿S SON ADMINISTERED 12 GLUCOSE TABLETS AND CONTACTED EMERGENCY MEDICAL SERVICES (EMS). UPON ARRIVAL, PARAMEDICS TRANSPORTED THE PATIENT TO THE EMERGENCY ROOM (ER), WHERE HE REGAINED CONSCIOUSNESS. A BG FINGER STICK PERFORMED AT THE ER SHOWED A VALUE OF 40 MG/DL. THE PATIENT WAS TREATED WITH GLUCAGON (ROUTE UNSPECIFIED) AND REMAINED IN THE ER FOR APPROXIMATELY 30 MINUTES UNTIL HIS CONDITION STABILIZED. THE PATIENT CONTINUED USING THE SAME CGM SENSOR UNTIL IT WAS REPLACED ON 08/18/2025. JUST PRIOR TO REMOVAL, THE SENSOR REMAINED INACCURATE, DISPLAYING A CGM VALUE OF 193 MG/DL WHILE THE BG METER SHOWED A VALUE OF 135 MG/DL. AT THE TIME OF THE REPORT, THE PATIENT WAS IN GOOD CONDITION. THE PATIENT WAS USING A TANDEM T:SLIM INSULIN PUMP; IT WAS NOT SPECIFIED WHETHER THE DEVICE WAS OPERATING IN MODIFIED CLOSED-LOOP MODE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID AT THE ER. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID PRIOR TO REMOVAL. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #109 - 3004753838-2025-241034 CRITICAL
View on MAUDE
Date of Event 2025-08-16
Patient Gender Female
Patient Age 47 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON 08/16/2025, IT WAS REPORTED THAT THE PATIENT TOOK A FINGERSTICK AND THE CGM READING WAS 150 MG/DL, AND THE BLOOD GLUCOSE READING WAS 35 MG/DL. INITIALLY THE PATIENT DID NOT EXPERIENCE SYMPTOMS AND ASKED HER NIECE TO BRING HER SOME JUICE, BUT THEN THE PATIENT SUDDENLY EXPERIENCED LOSS OF CONSCIOUSNESS. AN AMBULANCE WAS CALLED BY THE PATIENT´S NIECE. THE PATIENT WAS TAKEN TO THE HOSPITAL AND WAS TREATED WITH INTRAVENOUS FLUIDS. THE PATIENT REGAINED CONSCIOUSNESS AT THE HOSPITAL. WHEN A FINGERSTICK WAS TAKEN THE BLOOD GLUCOSE READING WAS 147 MG/DL. THE WEARABLE HAD BEEN REMOVED FOR AN MRI SCAN. NO FURTHER TREATMENT WAS REPORTED TO BE NEEDED AND THE PATIENT WAS DISCHARGED AT 04:00PM. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. WHEN THE PATIENT REGAINED CONSCIOUSNESS, THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALLS WITHIN THE B ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #110 - 3004753838-2025-239612 CRITICAL
View on MAUDE
Date of Event 2025-08-16
Patient Gender N/A
Patient Age N/A
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
D4 LOT NO - CORRECTION. PRIMARY UDI NUMBER - CORRECTION. H2 CORRECTION. | SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. DATE OF EVENT IS AN APPROXIMATION. ON 08/16/2025, IT WAS REPORTED THAT THE PEDIATRIC PATIENT WAS ILL FOR SEVERAL DAYS, HEADACHE, EYES HURTING, NOT EATING FOR COUPLE OF DAYS. AT 1PM HE PASSED OUT AND WAS VOMITING. THEY WAITED 40 MINUTES FOR AMBULANCE. MOTHER PUT NEW SENSOR ON AND TOOK A BG READING WHICH WAS IN RANGE AROUND 9 MMOL/L. THE PARAMEDICS DIDN'T PROVIDE ANY MEDICATION AS HE WAS IN RAGE WHEN SENSOR WAS CHANGED AND AMBULANCE ARRIVED. AT AN UNSPECIFIED TIME OF THE EVENT THE CGM WAS READING LOW AND THE BLOOD GLUCOSE READING WAS OVER 84 MMOL/L. ALTHOUGH THE BG WAS INDICATING SEVERE HYPERGLYCEMIA, THERE WAS NO TREATMENT DOCUMENTED FOR HYPERGLYCEMIA. AT THE TIME OF THE REPORT, IT TOOK THE PATIENT DAY AND HALF SETTLING BACK TO THINGS, HE WAS OK, BUT PROBABLY NOT GREAT. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #111 - 3004753838-2025-254911 CRITICAL
View on MAUDE
Date of Event 2025-08-15
Patient Gender Female
Patient Age 44 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT¿S CGM WAS READING LOW MG/DL. NO BG METER COMPARISON VALUE WAS TAKEN. THE PATIENT WAS WEARING A BETABIONINCS ILET INSULIN PUMP. THE PATIENT SELF-TREATED BY ¿EATING¿ TO INCREASE HER BG LEVEL. THAT NIGHT BEFORE GOING TO BED, THE PATIENT ¿PAUSED¿ HER INSULIN PUMP DELIVERY TO AVOID A LOW ALARM AND WENT TO SLEEP. AT SOME POINT DURING THE NIGHT, THE PATIENT LOST CONSCIOUSNESS. ON (B)(6) 2025, AROUND 2AM, THE PATIENT¿S BOYFRIEND CALLED EMERGENCY MEDICAL SERVICES (EMS). ONCE EMS ARRIVED, THE PATIENT¿S CGM WAS READING 76 MG/DL AND THE PATIENT¿S BG METER READING WAS 20 MG/DL. ACCORDING TO EMS, THE PATIENT¿S CGM GRAPH WAS SHOWING HER READINGS WERE GOING ¿UP AND DOWN¿. THE PATIENT WAS TREATED WITH GLUCOSE GEL AND APPLE JUICE. AFTER APPROXIMATELY 2 HOURS, EMS LEFT THE PATIENT. SHE WAS NOT TRANSPORTED TO THE EMERGENCY ROOM (ER). IT WAS NOT SPECIFIED WHEN DURING THE EVENT THE PATIENT REGAINED CONSCIOUSNESS. THE PATIENT WAS ¿FINE¿ AT THE TIME OF REPORT. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. ONCE EMS CAME, THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #112 - 3004753838-2025-255824 CRITICAL
View on MAUDE
Date of Event 2025-08-15
Patient Gender Female
Patient Age 84 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE SKIN. DATE OF EVENT IS AN APPROXIMATION. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT HAD A LOW READING CLOSE TO BEDTIME BUT SHE DID NOT BELIEVE THAT IT WAS ACCURATE BECAUSE SHE LOST CONSCIOUSNESS. SHE SAID THAT THERE WAS ONE TIME WHEN SHE GOT AN UN UNSPECIFIED LOW CGM ON THE RECEIVER, THE BG WAS 38 MG/DL. SHE FELT THIS CGM WAS HIGH BIAS INACCURATE. THE PATIENT COULD NOT RECALL WHEN THE CGM AND BG READINGS WERE TAKEN. SHE CONFIRMED THAT SHE WAS STILL AWARE OF WHAT WAS HAPPENING AROUND HER AT THAT TIME AND WHEN SHE WAS ASKED AGAIN IF SHE HAD LOST CONSCIOUSNESS, SHE SAID SHE DID NOT KNOW. SHE ALSO COULD NOT REMEMBER IF SHE HAD SYMPTOMS FOR THE LOW READINGS AND DID NOT MENTION SEEKING MEDICAL INTERVENTION, BEING GIVEN ANY TREATMENTS OR MEDICATIONS. THE PATIENT DISCONNECTED THE CALL. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE A ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #113 - 3004753838-2025-244973 CRITICAL
View on MAUDE
Date of Event 2025-08-15
Patient Gender Female
Patient Age 17 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON THE SAME DAY, IT WAS REPORTED THAT THE PEDIATRIC PATIENT EXPERIENCED HYPERGLYCEMIA AND WAS NOT VERY RESPONSIVE (NOT CONFIRMED IF THE PATIENT ACTUALLY LOST CONSCIOUSNESS AT SOME POINT). THE MOTHER TOOK THE PATIENT TO THE HOSPITAL ON (B)(6) BECAUSE OF THE HIGH BLOOD GLUCOSE BECAUSE THEY DIDN'T REALIZE THAT THE SENSOR ALREADY FAILED. THEY HAD TO STAY AT THE HOSPITAL FOR 24 HOURS. AT THE TIME OF THE REPORT THE PATIENT WAS OK. DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS CONFIRMED VIA DATA. THE PROBABLE CAUSE WAS DETERMINED TO BE LOW COUNT ABERRATION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #114 - 3004753838-2025-239610 CRITICAL
View on MAUDE
Date of Event 2025-08-15
Patient Gender Male
Patient Age 63 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON 08/15/2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SENSOR FAILURE THE DAY AFTER THE WEARABLE WAS PUT ON THE ARM. THIS COMPLAINT SAYS HE WAS AWARE OF IT BUT DOES NOT SAY WHAT THE LAST KNOW CGM WAS. THE PATIENT USES TANDEM TSLIM WHICH WOULD NOT HAVE BEEN IN MODIFIED CLOSED LOOP WITHOUT AN ACTIVE SENSOR SESSION. SOMETIME ALTER, THE SAME DAY, THE PATIENT BECAME UNCONSCIOUS AND WAS TAKEN TO THE HOSPITAL, ALTHOUGH HE DOES NOT RECALL HOW HE GOT THERE. UPON ARRIVAL, HIS BLOOD GLUCOSE (BG) METER WAS 600 MG/DL. AT THE HOSPITAL, HE WAS ADMINISTERED BOTH LONG-ACTING AND QUICK-ACTING INSULIN. THE PATIENT WAS CURRENTLY DOING WELL DURING THE FOLLOW-UP CALL ON 08/18/2025 AND IS HOPEFUL TO BE DISCHARGED THE NEXT DAY. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. PROBLEM COULD NOT BE CONFIRMED AND PROBABLE CAUSE CANNOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #115 - 3004753838-2025-253619 CRITICAL
View on MAUDE
Date of Event 2025-08-14
Patient Gender Female
Patient Age 36 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN. ACCORDING TO THE PATIENT, ON (B)(6) 2025, SHE HAD REPORTED HAVING FOUR SEIZURES AND WAS FOUND UNCONSCIOUS BY HER SON. THE PATIENT ALLEGED SHE WAS EXPERIENCING INACCURATE CGM VALUES, HOWEVER, NO SPECIFIC CGM OR BG METER COMPARISON VALUES WERE REPORTED. THE PATIENT WAS WEARING THE BETABIONICS ILET INSULIN PUMP. THE PATIENT¿S SON TREATED THE PATIENT WITH ORANGE JUICE AND THE PATIENT WAS TAKEN TO THE HOSPITAL. THE PATIENT DECLINED TO PROVIDE ANY FURTHER EVENT DETAILS INCLUDING MEDICATION PROVIDED WHILE HOSPITALIZED AND HOW LONG THE PATIENT WAS IN THE HOSPITAL PRIOR TO DISCHARGE. ATTEMPTS TO REACH THE PATIENT BACK FOR FURTHER EVENT CLARIFICATION WERE UNSUCCESSFUL. THE PATIENT WAS ¿FINE¿ AT THE TIME OF REPORT. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #116 - 3004753838-2025-253585 CRITICAL
View on MAUDE
Date of Event 2025-08-14
Patient Gender Male
Patient Age 37 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ACCORDING TO THE PATIENT¿S PARENT, ON APPROXIMATELY (B)(6) 2025, WHILE AT WORK, THE PATIENT FELT PALE, WOBBLY, AND LIGHTHEADED. THE PATIENT TOLD HIS SUPERVISOR SOMETHING WAS WRONG AND THEN HE COLLAPSED. A FEW MOMENTS LATER, THE PATIENT REGAINED CONSCIOUSNESS ON HIS OWN AND TOLD HIS BOSS HE NEEDED TO GO TO THE EMERGENCY ROOM (ER). IT WAS REPORTED THE PATIENT¿S CGM HAD BEEN PROVIDING THE PATIENT WITH ¿HIGH VALUES¿, WHICH THE REPORTER STATED WERE INACCURATE. THIS THEN CAUSED HIS TANDEM INSULIN PUMP TO DELIVER ADDITIONAL INSULIN THAT WAS NOT NEEDED, WHICH THEN CAUSED THE PATIENT TO LOSE CONSCIOUSNESS FROM HYPOGLYCEMIA. HOWEVER, NO SPECIFIC CGM OR BG METER COMPARISON VALUES WERE REPORTED. AT THE ER, THE PATIENT¿S INSULIN PUMP INFUSION SITE WAS INSPECTED AND A ¿POCKET OF INSULIN¿ WAS FOUND AND DRAINED. THE PATIENT WAS ALSO FOUND TO BE DEHYDRATED AND WAS TREATED WITH IV FLUIDS. A NEW INSULIN PUMP INFUSION SITE WAS ALSO PLACED, AND INSULIN WAS GIVEN. IT WAS NOT SPECIFIED HOW LONG THE PATIENT WAS IN THE ER PRIOR TO BEING DISCHARGED. THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #117 - 3004753838-2025-234339 CRITICAL
View on MAUDE
Date of Event 2025-08-14
Patient Gender Female
Patient Age 75 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | THE COMPLAINT STATES THAT "CGM ACCURACY" WAS REPORTED. ON 08/14/2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA WITH CIRCULATORY COLLAPSE (LOSS OF CONSCIOUSNESS). THE PATIENT HAD TO BE TAKEN TO HOSPITAL BY EMERGENCY DOCTOR. ALTHOUGH THE CGM WAS REPORTED INACCURATE, THERE WERE NO BG NOR CGMM VALUES REPORTED. NO OTHER DETAILS WERE DOCUMENTED. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. PROBLEM COULD NOT BE CONFIRMED AND PROBABLE CAUSE CANNOT BE DETERMINED. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #118 - 3004753838-2025-269128 CRITICAL
View on MAUDE
Date of Event 2025-08-13
Patient Gender Male
Patient Age 45 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT EXPERIENCED RECURRING EPISODES OF DIZZINESS FOR OVER TWO HOURS. WHILE CHECKING HIS INSULIN PUMP AND PHONE, HE NOTICED A ¿SENSOR FAILURE¿ ERROR MESSAGE AND WAS UNABLE TO VIEW ANY GLUCOSE READINGS. CONCERNED ABOUT HIS SYMPTOMS, HE CALLED 911. EMERGENCY RESPONDERS ARRIVED AND FOUND THE PATIENT SEVERELY DEHYDRATED AND AVAILABLE. IN DIABETIC KETOACIDOSIS (DKA). HE WAS ADMINISTERED IODINE SOLUTION, FOLIC ACID, AND PAIN MEDICATION ON-SITE. THE PATIENT CANNOT RECALL ANY GLUCOSE READINGS BEFORE HOSPITALIZATION, INCLUDING THOSE THAT MAY HAVE BEEN GATHERED BY EMERGENCY PERSONNEL, AS BOTH HIS PUMP AND PHONE DISPLAYED ONLY THE SENSOR FAILURE MESSAGE. HE WAS TRANSPORTED TO THE HOSPITAL UNCONSCIOUS AND REMAINED HOSPITALIZED FOR APPROXIMATELY 3 TO 5 DAYS. DURING HIS STAY, HE WAS UNABLE TO RECALL ANY GLUCOSE READINGS OR SPECIFIC DETAILS RELATED TO HIS CONDITION. AT THE TIME OF THE REPORT, THE PATIENT WAS DOING BETTER. DATA WAS RECEIVED BUT DOES NOT REFLECT FULL INVESTIGATION WINDOW. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED.
Report #119 - 3004753838-2025-268078 CRITICAL
View on MAUDE
Date of Event 2025-08-13
Patient Gender Female
Patient Age 46 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT WAS SLEEPING AND THE NEXT THING SHE KNEW WAS THAT SHE WAS LAYING FACE DOWN ON THE FLOOR FROM HYPOGLYCEMIA. THE PATIENT USES TANDEM TSLIM AND THIS COMPLAINT SAYS SHE WAS UNABLE/UNWILLING TO ANSWER WHETHER IT WAS IN MODIFIED CLOSED LOOP. THE PATIENT CANNOT TELL AT WHICH POINT THE SENSOR FAILED BECAUSE SHE WAS SLEEPING. NO FS READINGS NOR BG NOTED AS THE PATIENT SAID SHE DOES NOT KNOW BECAUSE SHE WAS UNCONSCIOUS. THE GLYCEMIC STATE WAS NOT DESCRIBED. TREATMENT AND MANAGEMENT OF THE PATIENT'S CONDITION WAS NOT DOCUMENTED. SHE DID NOT SEEK HEALTH CARE PROFESSIONAL (HCP) WHEN THE ISSUE HAPPENED. WHEN ASKED QUESTIONS, SHE EITHER REFUSED OR SAID SHE DIDN'T KNOW THE ANSWER TO THE QUESTION. DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS NOT CONFIRMED VIA DATA. HOWEVER, NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE UNDER AN HOUR WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. H6: MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. PLEASE DISREGARD "H6: HEALTH EFFECT CLINICAL CODE - NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS" AS THIS CODE IS NOT APPLICABLE FOR THIS REPORT.
Report #120 - 3004753838-2025-260623 CRITICAL
View on MAUDE
Date of Event 2025-08-13
Patient Gender N/A
Patient Age N/A
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4) H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN APPLICATOR DEPLOYMENT OCCURRED. THE WEARABLE WAS INSERTED INTO THE ABDOMEN, WHICH IS AN OFF-LABEL USAGE OF THE DEVICE, ON (B)(6) 2025. THE DATE OF THE EVENT IS AN APPROXIMATION. ON APPROXIMATELY (B)(6) 2025, THE PATIENT INSERTED A NEW WEARABLE DEVICE AND WAS WAITING FOR IT TO PAIR. UPON CHECKING THE DISPLAY, THE DEVICE CONTINUED TO SHOW ¿SEARCHING FOR DEVICE.¿ SHORTLY THEREAFTER, THE PATIENT LOST CONSCIOUSNESS AND WAS FOUND BY HIS BROTHER, WHO CALLED EMERGENCY MEDICAL SERVICES (EMS). UPON ARRIVAL, EMS PERSONNEL NOTED THAT THE WEARABLE DEVICE WAS ¿NOT PROPERLY ATTACHED¿ AND ADVISED THAT IT NEEDED TO BE REPLACED. THE PATIENT LATER REPORTED THAT THE ¿WIRE WASN'T ABLE TO GET INTO HIS SKIN.¿ THERE WAS NO DOCUMENTATION OF THE PATIENT¿S BLOOD GLUCOSE METER (BGM) READING AT THE TIME OF THE INCIDENT. THE PATIENT WAS TREATED WITH AN UNSPECIFIED INTRAVENOUS (IV) MEDICATION AND EVENTUALLY REGAINED CONSCIOUSNESS, THOUGH HE REPORTED FEELING ¿SLUGGISH AND WEAK.¿ THERE IS NO DOCUMENTATION INDICATING THAT THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM (ER). AT THE TIME OF THE REPORT, THE PATIENT WAS CONSIDERED STABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #121 - 3004753838-2025-247431 CRITICAL
View on MAUDE
Date of Event 2025-08-13
Patient Gender Female
Patient Age 63 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. | IT WAS REPORTED THAT NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ACCORDING TO THE PATIENT, ON APPROXIMATELY (B)(6) 2025, THE PATIENT WAS NOT GETTING READINGS ON THEIR CONTINUOUS GLUCOSE MONITOR (CGM). THE PATIENT WAS UNAWARE THAT HER BLOOD SUGAR IS ALREADY LOW, AND SHE PASSED OUT. THE PATIENT WAS UNABLE TO RECALL HOW LONG THE SENSOR ERROR OCCURRED. THE PATIENT¿S NIECE CALLED AN AMBULANCE. THE PARAMEDICS REMOVED THE PATIENT¿S SENSOR AND TOOK HER BG MANUALLY, WHICH WAS 38 MG/DL. PARAMEDICS INJECTED AN IV WITH "SUGAR MEDICINE." THE PATIENT REGAINED CONSCIOUSNESS AND DECLINED TO GO TO THE HOSPITAL. DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS NOT CONFIRMED VIA DATA. HOWEVER, IT WAS FOUND THAT NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE UNDER AN HOUR OCCURRED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #122 - 3004753838-2025-239852 CRITICAL
View on MAUDE
Date of Event 2025-08-13
Patient Gender N/A
Patient Age N/A
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE UPPER BUTTOCKS, WHICH IS OFF-LABEL USAGE OF THE DEVICE, ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT EXPERIENCED A SEIZURE AND LOSS OF CONSCIOUSNESS. THE PATIENT¿S CGM WAS READING 120 MG/DL AND THE BG METER WAS READING 44 MG/DL. THE PATIENT WAS USING AN OMNIPOD INSULIN PUMP IN CLOSED LOOP MODE. THE PATIENT¿S FATHER CALLED EMERGENCY MEDICAL SERVICES (EMS) AND, IN THE MEANTIME, THE PATIENT¿S SIBLING ADMINISTERED GLUCAGON TO THE PATIENT. ONCE EMS ARRIVED, THE PATIENT¿S CGM WAS STILL READING 120 MG/DL AND THE BG METER WAS STILL READING 44 MG/DL. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM. AT THE ER, THE PATIENT¿S CGM WAS READING 150 MG/DL AND THE BG METER WAS READING 106 MG/DL. THE PATIENT¿S WEARABLE WAS REMOVED AND THE PATIENT WAS TREATED WITH IV FLUIDS. THE PATIENT ALSO HAD A CT (COMPUTED TOMOGRAPHY) SCAN DONE TO RULE OUT ANY INJURIES FROM THE SEIZURE. NO INJURIES WERE FOUND. THE PATIENT WAS DISCHARGED AFTER APPROXIMATELY 6 HOURS. THE PATIENT WAS ¿STABLE¿ AT THE TIME OF REPORT. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #123 - 3004753838-2025-238321 CRITICAL
View on MAUDE
Date of Event 2025-08-13
Patient Gender Male
Patient Age 66 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. THE DATE OF EVENT IS AN APPROXIMATION. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT'S DEVICE DIDN´T ALERTED THE PATIENT FOR HYPOGLYCEMIA. WHILE THE PATIENT WAS DRIVING HOME FROM THE GROCERY STORE, HE FELT DIZZY AND DISORIENTED. HE COULD NOT REMEMBER HIS CGM READINGS. WHEN THE PATIENT ARRIVED HOME, HE IMMEDIATELY SAT DOWN AND LOST CONSCIOUSNESS. HIS WIFE IS THE ONE WHO FOUND THE PATIENT UNCONSCIOUS. THE SPOUSE TRIED TO REVIVE THE PATIENT WITH HONEY. THE PATIENT REGAINED CONSCIOUSNESS AND THEY IMMEDIATELY CHECKED THE CGM READING WHICH WAS 137 MG/DL WITH AN ARROW POINTING DOWN. THERE WAS NO BG TAKEN. THE PATIENT WAS IN GOOD CONDITION. DATA HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. | (B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #124 - 3004753838-2025-238538 CRITICAL
View on MAUDE
Date of Event 2025-08-13
Patient Gender Female
Patient Age 10 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT "NO READINGS", "SENSOR ERROR"" OR ""BRIEF SENSOR ISSUE" OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT WAS VOMITING, WEAK, HAD NO ENERGY, NAUSEOUS, AND FAINTED. THE PATIENT¿S CGM WAS IN A BRIEF SENSOR ERROR STATE AND THE PATIENT¿S BG METER READING WAS 475 MG/DL. EMERGENCY MEDICAL SERVICES (EMS) WAS CALLED AND ONCE THEY ARRIVED, THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM (ER). AT THE ER, THE PATIENT¿S BG METER WAS READING OVER 500 MG/DL AND THE CGM WAS STILL IN A SENSOR ERROR STATE. THE PATIENT WAS TREATED WITH IV FLUIDS. IT WAS NOT SPECIFIED WHEN DURING THE EVENT THE PATIENT REGAINED CONSCIOUSNESS. THE PATIENT WAS DISCHARGED HOME AFTER APPROXIMATELY ¿HALF A DAY¿ IN THE ER. THE PATIENT WAS ¿DOING FINE¿ AT THE TIME OF REPORT. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #125 - 3004753838-2025-237643 CRITICAL
View on MAUDE
Date of Event 2025-08-13
Patient Gender Female
Patient Age 34 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT A DEXCOM APP CRASH OCCURRED. ON (B)(6) 2025, AT APPROXIMATELY 2:44 PM, THE PATIENT PASSED OUT WHILE RETRIEVING LAUNDRY FROM THE FLOOR. THE PATIENT WAS UNAWARE OF HER GLUCOSE LEVEL AT THE TIME DUE TO A MALFUNCTIONING APP. SHE REPORTED THAT THE LAST THING SHE REMEMBERED WAS REACHING FOR LAUNDRY, AND UPON REGAINING CONSCIOUSNESS, HER HUSBAND WAS ATTEMPTING TO REVIVE HER BY GENTLY RUBBING HER FACE WITH A CLOTH. NO MEDICAL TREATMENT WAS DOCUMENTED FOLLOWING THE INCIDENT. AT THE TIME OF THIS REPORT, THE PATIENT IS STABLE AND REPORTS FEELING OKAY. NO DATA OR PRODUCT WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Report #126 - 3004753838-2025-243651 CRITICAL
View on MAUDE
Date of Event 2025-08-12
Patient Gender Male
Patient Age 67 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. ON 08/12/2025, IT WAS REPORTED THAT THE PATIENT LOST CONSCIOUSNESS DUE TO SYMPTOMS OF HYPOGLYCEMIA AND WAS TAKEN TO THE HOSPITAL. AT THE TIME, THE G7 SHOWED A VALUE OF 190 MG/DL, BUT NO BG MEASUREMENT WAS TAKEN. THE ABOVE MEASUREMENT WAS TAKEN AFTER THE PATIENT HAD STABILIZED AT THE HOSPITAL. AT AN UNSPECIFIED TIME OF THE EVENT THE BG WAS 74 MG/DL AND THE CGM READING WAS 195 MG/DL. AT THE HOSPITAL THE PATIENT WAS TREATED WITH IV MEDICATION. AT THE TIME OF THE REPORT THE PATIENT WAS STILL RECOVERING. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #127 - 3004753838-2025-238177 CRITICAL
View on MAUDE
Date of Event 2025-08-12
Patient Gender Male
Patient Age 84 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. ON (B)(6) 2025, THE PATIENT WAS REPORTEDLY SWEATING AND LETHARGIC. HE WAS "NOT MAKING ANY SENSE" AND "GETTING CLOSE TO A COMA". THE CGM WAS READING 50 MG/DL AND THERE WAS NO BLOOD GLUCOSE READING DOCUMENTED. THE PATIENT'S CHILD TREATED THE PATIENT WITH JELLY AND THE PATIENT RECOVERED AFTER THE TREATMENT. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | (B)(4). D4 CATALOG NO - CORRECTION D4 PRIMARY UDI NUMBER - CORRECTION E1 INITIAL REPORTER FIRST NAME - CORRECTION H2 CORRECTION. | SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED.
Report #128 - 3004753838-2025-248523 CRITICAL
View on MAUDE
Date of Event 2025-08-11
Patient Gender Male
Patient Age 28 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. | IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ACCORDING TO THE PATIENT, ON (B)(6) 2025, THEY EXPERIENCED A HYPOGLYCEMIC EVENT. DURING THE NIGHT OF THE EVENT THE PATIENT EXPERIENCED A SEIZURE AND LOST CONSCIOUSNESS. WHEN THE PATIENT REGAINED CONSCIOUSNESS, THE CGM DEVICE WAS SHOWING A SENSOR FAILURE. THE PATIENT FELT UNWELL AND WHEN THEY TOOK A FINGERSTICK, THE BLOOD GLUCOSE READING WAS 50 MG/DL. THE PATIENT SELF-TREATED BY CONSUMING SUGAR AND DID NOT GO TO THE HOSPITAL. NO FURTHER TREATMENT WAS REPORTED TO BE NEEDED. THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION. DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS CONFIRMED VIA DATA. THE PROBABLE CAUSE WAS DETERMINED TO BE VERY LOW COUNT ABERRATION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #129 - 3004753838-2025-239613 CRITICAL
View on MAUDE
Date of Event 2025-08-11
Patient Gender Male
Patient Age 81 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM, WHICH IS OFF-LABEL USAGE OF THE DEVICE, ON (B)(6) 2025. ON APPROXIMATELY (B)(6) 2025, THE PATIENT WAS "UNABLE TO FUNCTION" AND LOST CONSCIOUSNESS. THE CGM READING WAS 304 MG/DL. NO FINGERSTICK WAS TAKEN, BUT AS THE SYMPTOMS DID NOT MATCH THE CGM READING, THE PATIENT´S WIFE TREATED THE PATIENT WITH BAQSIMI NASAL GLUCAGON. THE WIFE GAVE THE PATIENT MAPLE SYRUP, ALONG WITH OTHER CARBOHYDRATES. THE EMERGENCIES WERE CALLED AND WHEN THE PARAMEDICS TOOK A FINGERSTICK THE CGM READING WAS 100 MG/DL, AND THE BLOOD GLUCOSE READING WAS 17 MG/DL. LATER FINGERSTICKS SHOWED A BLOOD GLUCOSE READING OF 26 AND 35 MG/DL. AN ECG (ELECTROCARDIOGRAM) READING WAS MADE, BUT NO FURTHER TREATMENT WAS PROVIDED BY THE PARAMEDICS. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR WHEN THE PATIENT HAD SYMPTOMS. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID WHEN CHECKED BY THE EMS. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALLS WITHIN THE C ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #130 - 3004753838-2025-246574 CRITICAL
View on MAUDE
Date of Event 2025-08-10
Patient Gender Male
Patient Age 30 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. A TANDEM SALES REPRESENTATIVE REPORTED THAT ON (B)(6) 2025, THE PATIENT¿S GIRLFRIEND FOUND HIM UNRESPONSIVE AT HOME BETWEEN 1000-1100. THE TANDEM REPORTER RECEIVED THESE DETAILS FROM THE OUTPATIENT ENDOCRINOLOGY CLINIC AND THE INPATIENT ENDOCRINOLOGY FELLOW CARING FOR THE PATIENT. ACCORDING TO REPORTS RECEIVED, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CEREBRAL EDEMA DUE TO PROLONGED HYPOGLYCEMIA. HE WEARS A TANDEM MOBI AND DEXCOM G7. HIS G7 WAS READING OVER 300S ALL NIGHT. ONCE HIS SLEEP MODE TURNED OFF IN THE MORNING (WHILE HE WAS STILL SLEEPING), HIS PUMP GAVE HIM 5 AUTO-BOLUS OVER THE NEXT FEW HOURS ACCORDING TO CONTROL IQ SPECIFICATIONS. WHEN EMERGENCY MEDICAL SERVICES (EMS) ARRIVED, HIS BG WAS 37 MG/DL, EVEN THOUGH HIS DEXCOM WAS READING 309 MG/DL. HE HAS A POOR NEUROLOGIC PROGNOSIS. AT THE TIME OF THIS REPORT, HE HAD BEEN IN THE INTENSIVE CARE UNIT FOR THE PAST WEEK AND A HALF. AT THE TIME THE REPORT WAS MADE TO DEXCOM, HE WAS INTUBATED AND ON A VENTILATOR. DATA HAS BEEN REQUESTED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. THE REPORTED GLUCOSE VALUES FALL WITHIN THE E ZONE OF THE PARKES ERROR GRID (CGM 309 MG/DL; BG METER 37 MG/DL). NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #131 - 3004753838-2025-236666 CRITICAL
View on MAUDE
Date of Event 2025-08-10
Patient Gender Female
Patient Age 68 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CGM ACCURACY ISSUE WHILE DRIVING HOME AND THEY FELT EXTREMELY TIRED AND DROWSY AND ALMOST FELL ASLEEP AT THE WHEEL. ONCE THE PATIENT GOT HOME, SHE WALKED IN THE HOUSE AND ¿BLACKED OUT¿ AND HIT HER HEAD. THE PATIENT HAD A SEVERE HEADACHE AFTER THE FALL. THE PATIENT ALSO MENTIONED SHE HAD PRE-EXISTING KNEE PROBLEMS WHICH SHE BELIEVES MAY HAVE BEEN THE REASON SHE FELL. THE PATIENT¿S HUSBAND HELPED HER SIT DOWN IN A CHAIR. THE PATIENT¿S CGM WAS READING 122 MG/DL AND THE PATIENT¿S BG METER WAS READING 69 MG/DL. THE PATIENT SAID SHE REMAINED SEATED UNTIL SHE WAS STRONG ENOUGH TO STAND AND MOVE AROUND. THE PATIENT DID NOT TAKE ANY MEDICATION OR TREATMENT AND DECIDED TO LIE DOWN AND GO TO SLEEP. THERE WAS NO DOCUMENTATION OF MEDICAL INTERVENTION. THE PATIENT WAS ¿FINE¿ AT THE TIME OF REPORT. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #132 - 3004753838-2025-244698 CRITICAL
View on MAUDE
Date of Event 2025-08-09
Patient Gender N/A
Patient Age N/A
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS. | IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON 08/09/2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SENSOR FAILURE WITH HER DEXCOM G7 DEVICE. THE "RECEIVER" AND MOBILE DISPLAYS SHOWED THE ALERT: ¿REPLACE SENSOR NOW.¿ THE PATIENT REPORTED THAT SHE WAS ENTIRELY TOO SICK TO ADDRESS ANYTHING AND WAS UNABLE TO PERFORM A FINGERSTICK BLOOD GLUCOSE CHECK. SHE BEGAN EXPERIENCING ¿VOLATILE VOMITING¿, DESCRIBING IT AS BEING UNABLE TO KEEP DOWN EVEN A SIP OF WATER. SHE ALSO NOTED A ¿HEAVY FEELING OF SICKNESS, LIKE ILLNESS¿, WHICH PRECEDED HER PROGRESSION INTO FULL-BLOWN DKA (DIABETIC KETOACIDOSIS). HER CONDITION DETERIORATED RAPIDLY, AND SHE BECAME COMATOSE. THE LAST KNOWN CGM WAS NOT DOCUMENTED. THE MOMENT OF COMA WAS NOT DOCUMENTED. ON (B)(6) 2025, THE PATIENT WAS TAKEN TO THE HOSPITAL BY AMBULANCE AFTER HER HUSBAND CALLED 911, STATING SHE WAS ¿NOT COHERENT ENOUGH AND ALL I WAS DOING WAS MOANING.¿ SHE WAS INITIALLY ADMITTED TO A NEARBY HOSPITAL AND THEN TRANSFERRED TO A DIFFERENT HOSPITAL THAT COULD PROVIDE THE NECESSARY CARE. UPON ARRIVAL, SHE WAS DIAGNOSED WITH DKA AND PNEUMONIA, THE LATTER RESULTING FROM ASPIRATION. SHE RECEIVED ANTIEMETIC AND ANTIBIOTIC. TREATMENT AND MANAGEMENT OF DKA WAS NOT DESCRIBED. ONCE SHE REGAINED COHERENCE, SHE HOOKED UP HER UNSPECIFIED INSULIN PUMP. DUE TO HER ¿WEAKNESS AND THE VOMITING AND THE DEHYDRATION AND THE COMATOSE STATE,¿ SHE REMAINED BEDRIDDEN FOR THE NEXT DAY. ALL CARE WAS PROVIDED IN THE HOSPITAL. THE PATIENT REMAINED HOSPITALIZED FROM (B)(6) 2025, TOTALING FIVE DAYS. SHE WAS NOT ALLOWED TO LEAVE THE ICU UNTIL A NEW SENSOR WAS IN PLACE, WHICH SHE APPLIED ON (B)(6) 2025. PERFORMANCE DATA WAS REVIEWED. THE ALLEGATION WAS NOT CONFIRMED VIA DATA. THE PROBABLE CAUSE COULD NOT BE DETERMINED POST INVESTIGATION AS THE ALLEGATION WAS NOT FOUND. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Report #133 - 3004753838-2025-243716 CRITICAL
View on MAUDE
Date of Event 2025-08-09
Patient Gender Female
Patient Age 17 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE THIGH, WHICH IS OFF-LABEL USAGE OF THE DEVICE ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT REPORTED EXPERIENCING CGM INACCURACIES, WHICH REQUIRED THREE CALIBRATIONS OF THE DEVICE. ON (B)(6) 2025, THE PATIENT EXPERIENCED A SEIZURE AND LOSS OF CONSCIOUSNESS WHILE IN THE BATHROOM. AT THE TIME OF THE EVENT, THE CGM READING WAS 108 MG/DL, WHICH SHORTLY AFTER DROPPED TO 62 MG/DL. THE SEIZURE LASTED LESS THAN ONE MINUTE, AND THE PATIENT RETURNED TO BASELINE WITHIN APPROXIMATELY 30 MINUTES. ONCE ABLE, THE PATIENT¿S BG METER READING WAS 132 MG/DL. EMERGENCY MEDICAL SERVICES (EMS) OR HIGHER-LEVEL CARE WERE NOT CONSULTED, AND THERE WAS NO DOCUMENTATION OF MEDICAL TREATMENT OR INTERVENTION. THE PATIENT¿S PARENT MONITORED BLOOD PRESSURE, SPEECH PATTERN, AND PUPIL RESPONSE DURING RECOVERY. THE REPORT NOTED THAT THE BG METER READING DURING THE EVENT WAS WITHIN AN ¿EXPECTED RANGE¿ THAT WOULD NOT TYPICALLY TRIGGER A SEIZURE. AS A RESULT, THE FAMILY IS STILL TRYING TO DETERMINE WHETHER THE PRIOR CGM INACCURACIES MAY HAVE CONTRIBUTED TO THE EVENT. AT THE TIME OF THE REPORTING, THE PATIENT WAS STILL RECOVERING. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #134 - 3004753838-2025-236716 CRITICAL
View on MAUDE
Date of Event 2025-08-08
Patient Gender Male
Patient Age 34 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON THE SAME DAY, IT WAS REPORTED THAT THE PATIENT WAS FOUND IN HIS YARD UNCONSCIOUS. THE PATIENT¿S PARENT RECEIVED A PHONE CALL FROM THE FIRE CHIEF NOTIFYING HER THAT THE PATIENT HAD BEEN TAKEN BY AMBULANCE TO THE EMERGENCY ROOM (ER). AT THE ER, THE PATIENT¿S CGM SHOWED A SENSOR FAILURE (BIG RED "X" ON THE PATIENT'S TANDEM INSULIN PUMP) AND HIS BG LEVEL WAS 1400 MG/DL. SINCE THE PATIENT WAS UNCONSCIOUS AND THE PATIENT¿S PARENT WAS NOT WITH THE PATIENT DURING THE EVENT, IT IS NOT KNOWN HOW LONG THE WEARABLE WAS IN A FAILURE STATE OR WHAT THE PATIENT¿S LAST KNOWN CGM VALUE WAS PRIOR TO THE WEARABLE FAILURE. THE WEARABLE WAS REMOVED AND THE PATIENT WAS TREATED WITH IV FLUIDS, IV INSULIN, POTASSIUM, MAGNESIUM, AND ANTI-NAUSEA MEDICATION. THE PATIENT WAS STILL IN THE ICU AT THE TIME OF REPORT. PERFORMANCE DATA WAS REVIEWED. THE ALLEGATION WAS CONFIRMED DUE TO FINDINGS OF WEARABLE FAILURE. THE PROBABLE CAUSE WAS DETERMINED TO BE HIGH COUNTS ABERRATION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. | (B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #135 - 3004753838-2025-233523 CRITICAL
View on MAUDE
Date of Event 2025-08-08
Patient Gender Female
Patient Age 17 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT A SIGNAL LOSS OCCURRED. THE WEARABLE WAS INSERTED INTO THE ABDOMEN WHICH IS AN OFF-LABEL USAGE OF THE DEVICE ON (B)(6) 2025. ON (B)(6) 2025, THE REPORTER HEARD SCRATCHING IN THE HOUSE. WHEN SHE CHECKED ON THE PATIENT, THE PATIENT WAS LYING UNRESPONSIVE, SWEATING PROFUSELY, AND HER EYES ROLLED BACK. THE PATIENT¿S CGM WAS IN A SIGNAL LOSS STATE ON THE DEXCOM MOBILE APP. THE REPORTER CALLED EMERGENCY MEDICAL SERVICES. ONCE EMS ARRIVED, THE PATIENT¿S BG METER READING WAS 40 MG/DL AND THE CGM WAS STILL IN A SIGNAL LOSS STATE. EMS TREATED THE PATIENT WITH A GLUCAGON INJECTION AND TRANSPORTED THE PATIENT TO THE EMERGENCY ROOM. AT THE ER, UNSPECIFIED BLOOD WORK AND A URINALYSIS WAS DONE. HER BG METER READING WAS 123 MG/DL AND THE CGM WAS STILL IN SIGNAL LOSS. THE PATIENT WAS DIAGNOSED WITH A URINARY TRACT INFECTION AND WAS TREATED WITH CEFALEXIN. AROUND 11AM, THE PATIENT¿S BG METER READING WAS 130 MG/DL WITH THE CGM STILL IN SIGNAL LOSS. THE PATIENT WAS DISCHARGED HOME LATER THE SAME DAY. THE FAMILY ALSO BOUGHT A BG METER TO USE DUE TO THE PATIENT¿S FLUCTUATING BG LEVELS. THE PATIENT WAS ¿STABLE¿ AND UNDER CLOSE OBSERVATION BY THE REPORTER AT THE TIME OF REPORT. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Report #136 - 3004753838-2025-233620 CRITICAL
View on MAUDE
Date of Event 2025-08-08
Patient Gender Female
Patient Age NA
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON APPROXIMATELY (B)(6) 2025, THE PATIENT EXPERIENCED HYPOGLYCEMIA WITH LOSS OF CONSCIOUSNESS. THE HUSBAND CALLED THE AMBULANCE. AT THE TIME OF THE REPORT THE PATIENT WAS FINE. AT AN UNSPECIFIED TIME OF THE EVENT THE CGM READING WAS 100 MG/DL AND THE BG READING WAS 45 MG/DL. THERE WAS NO INFORMATION ABOUT THE TREATMENT PROVIDED. AT THE TIME OF THE REPORT, THE PATIENT WAS DOING FINE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #137 - 3004753838-2025-257115 CRITICAL
View on MAUDE
Date of Event 2025-08-07
Patient Gender Male
Patient Age 75 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. IT WAS INDICATED THAT THE PATIENT RUBBED/BUMPED/LAID ON THE TRANSMITTER, WHICH IS MISUSE OF THE DEVICE. DATE OF EVENT IS AN APPROXIMATION. ON (B)(6) 2025, THE PATIENT WOKE UP DUE TO A LOW ALERT WITH A CGM READING OF 57 MG/DL AND EVENTUALLY LOST CONSCIOUSNESS. NO FINGERSTICKS OR CALIBRATIONS WERE REPORTED BEFORE THE PATIENT PASSED OUT. WHEN THE PATIENT REGAINED CONSCIOUSNESS, HE NOTICED THAT THE CGM SENSOR HAD COME OFF. PARAMEDICS WERE CALLED AND A FINGERSTICK OF 55 MG/DL WAS MEASURED. THE PATIENT WAS GIVEN SOME PEANUT BUTTER, CRACKERS AND ORANGE JUICE TO RAISE HIS BLOOD GLUCOSE LEVEL. WHEN A FINGERSTICK WAS TAKEN AFTER TREATMENT THE BLOOD GLUCOSE READING WAS 80 MG/DL. THE PATIENT WAS NOT BROUGHT TO THE HOSPITAL. NO OTHER MEDICATION/TREATMENT WAS GIVEN TO THE PATIENT. THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #138 - 3004753838-2025-237352 CRITICAL
View on MAUDE
Date of Event 2025-08-07
Patient Gender Female
Patient Age 40 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. SOMETIME AFTER INSERTION, THE MOBILE DEVICE DISPLAYED AN ESTIMATED GLUCOSE VALUE (EGV) OF 250 MG/DL. HOWEVER, THE PATIENT¿S ACTUAL BG WAS 20 MG/DL, RESULTING IN LOSS OF CONSCIOUSNESS. THE PATIENT¿S HUSBAND CALLED 911, AND PARAMEDICS ARRIVED SHORTLY THEREAFTER. AT THAT TIME, THE BG WAS 30 MG/DL, WHILE THE MOBILE DEVICE SHOWED AN EGV OF 300 MG/DL. THE PATIENT WAS ADMINISTERED 3 MG OF BAQSIMI BY PARAMEDICS. ALTHOUGH PARAMEDICS RECOMMENDED HOSPITAL TRANSPORT FOR FURTHER EVALUATION, THE PATIENT DECLINED. PARAMEDICS REMAINED ON-SITE FOR APPROXIMATELY 30 MINUTES TO MONITOR THE PATIENT¿S CONDITION. A FINAL FINGERSTICK READING BEFORE THEIR DEPARTURE SHOWED A BG OF 120 MG/DL. THE PATIENT USES AN INSULET OMNIPOD 5 IN A MODIFIED CLOSED-LOOP SYSTEM. AT THE TIME OF THIS REPORT, THE PATIENT IS REPORTED TO BE DOING FINE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE E ZONE OF THE PARKES ERROR GRID WERE TAKEN BEFORE AND WHEN THE PARAMEDICS ARRIVED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR BEFORE THE PARAMEDICS LEFT. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #139 - 3004753838-2025-235045 CRITICAL
View on MAUDE
Date of Event 2025-08-07
Patient Gender N/A
Patient Age N/A
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITORSTP-GT-002)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). | SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION IS PROVIDED. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS BUT HE MANAGED TO CALL HIS WIFE PRIOR TO LOSING CONSCIOUSNESS. AT SOME POINT THE PATIENT REGAINED CONSCIOUSNESS AND SELF-TREATED WITH SWEETS. A DOCTOR WAS CALLED AND WHEN HE ARRIVED THE DOCTOR THE PATIENT WAS ALREADY RECOVERED. AT AN UNSPECIFIED TIME OF THE REPORT THE CGM READING WAS 82 MG/DL AND THE CGM READING WAS 210 MG/DL (NOT CONFIRMED IF THIS WAS AFTER THE TREATMENT). DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALL WITHIN THE A ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #140 - 3004753838-2025-235971 CRITICAL
View on MAUDE
Date of Event 2025-08-06
Patient Gender Female
Patient Age 76 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. | IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. ON (B)(6) 2025, THE PATIENT REPORTED THAT SHE DID NOT RECEIVE AN ALERT FROM HER CGM MOBILE APP. SHE AWOKE TO FIND HER CGM DISPLAYING A GLUCOSE READING OF 40 MG/DL. APPROXIMATELY ONE MINUTE LATER, SHE LOST CONSCIOUSNESS. A CAREGIVER CONTACTED EMERGENCY SERVICES, AND PARAMEDICS TRANSPORTED HER TO THE HOSPITAL. THE PATIENT COULD NOT RECALL WHETHER HER BLOOD GLUCOSE WAS CHECKED BY PARAMEDICS ON-SITE; HOWEVER, UPON ARRIVAL AT THE HOSPITAL, HER BLOOD GLUCOSE WAS CONFIRMED TO BE 40 MG/DL. SHE WAS TREATED WITH IV FLUIDS AND REMAINED HOSPITALIZED FOR TWO DAYS. THE PATIENT USES A TANDEM T:SLIM INSULIN PUMP BUT WAS UNSURE WHETHER IT WAS OPERATING IN MODIFIED CLOSED-LOOP MODE AT THE TIME OF THE INCIDENT. AT THE TIME OF THE REPORT, THE PATIENT STATED SHE WAS FEELING BETTER. DATA HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #141 - 3004753838-2025-232275 CRITICAL
View on MAUDE
Date of Event 2025-08-06
Patient Gender Female
Patient Age 52 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT'S CGM STOPPED WORKING DURING THE NIGHT, AND AS A RESULT SHE DID NOT RECEIVE NOTIFICATION HER BG LEVEL WAS LOW. SHE DID NOT REMEMBER EVENT DETAILS INCLUDING THE TIME THE FAILURE OCCURRED. SHE LOST CONSCIOUSNESS AND HAD A SEIZURE. EMERGENCY MEDICAL SERVICES (EMS) WAS CALLED AND THE BG FINGER STICK VALUE BY PARAMEDICS WAS 20 MG/DL. SHE REGAINED CONSCIOUSNESS AFTER GLUCOSE ADMINISTRATION (UNSPECIFIED FORM). THE BG FS VALUE INCREASED TO APPROXIMATELY 30 MG/DL AND SHE ALSO WAS GIVEN FOOD. SHE WAS TRANSPORTED TO THE HOSPITAL FOR FURTHER EVALUATION AND UNSPECIFIED TREATMENT. AFTER THE EVENT SHE RECOVERED. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. PROBLEM COULD NOT BE CONFIRMED AND PROBABLE CAUSE CANNOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #142 - 3004753838-2025-229887 CRITICAL
View on MAUDE
Date of Event 2025-08-06
Patient Gender N/A
Patient Age N/A
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT NOTICED SHE WAS EXPERIENCING LOW GLUCOSE READING, SINCE HER DEXCOM READING WAS SHOWING 66MG/DL. AT AROUND 10:00 PM, SHE DECIDED TO EAT SOME PEANUT BUTTER BEFORE GOING TO BED. HER GLUCOSE READING THEN INCREASED TO 99 MG/DL. SHE DID NOT EXPERIENCE ANY SYMPTOMS AT THAT TIME. AT APPROXIMATELY 2:00 AM ON (B)(6) 2025, HER HUSBAND NOTICED THAT HER DEXCOM WAS SHOWING A READING OF 56 MG/DL, AND THE PATIENT APPEARED UNCONSCIOUS, AS IF EXPERIENCING A DIABETIC SHOCK. HER HUSBAND IMMEDIATELY CALLED 911, AND EMERGENCY RESPONDERS ARRIVED WITHIN 5 MINUTES. UPON ARRIVAL, THE PARAMEDICS TESTED THE PATIENT'S BLOOD GLUCOSE, WHICH SHOWED 32 MG/DL, WHILE THE DEXCOM DEVICE WAS STILL DISPLAYING 56 MG/DL. THE PATIENT REGAINED CONSCIOUSNESS AROUND 3:00 AM. SHE REPORTED FEELING HEAVY AND FATIGUED. THE PARAMEDICS ADMINISTERED A GLUCOSE DRIP. ONCE THE PATIENT WAS STABLE, THE PARAMEDICS TESTED HER BLOOD GLUCOSE AGAIN, WHICH SHOWED 250 MG/DL, WHILE THE DEXCOM DEVICE WAS EXPERIENCING SIGNAL LOSS. AFTER APPROXIMATELY 10 MINUTES OF SIGNAL LOSS, THE DEXCOM READINGS RESUMED AND SHOWED 89 MG/DL. THE PATIENT PERFORMED A MANUAL BLOOD GLUCOSE TEST, WHICH SHOWED 147 MG/DL. DESPITE MULTIPLE CALIBRATION ATTEMPTS, THE DEXCOM CONTINUED TO SHOW INCONSISTENT READINGS. AS A RESULT, THE PATIENT DECIDED TO REMOVE THE SENSOR. AT THE TIME OF THE REPORT, THE PATIENT WAS IN STABLE CONDITION. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID WAS TAKEN WHEN THE PARAMEDICS ARRIVED AND AFTER THE PARAMEDICS LEFT. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #143 - 3004753838-2025-255754 CRITICAL
View on MAUDE
Date of Event 2025-08-05
Patient Gender N/A
Patient Age N/A
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE EVENT DATE IS AN APPROXIMATION. ON 08/05/2025, IT WAS REPORTED BY EMAIL FROM ELI LILY THAT THE PATIENT STATED HE WAS SLEEPING, THEN CGM ALARM WOKE HIM UP AROUND 3:30 PM. THE ALARM WAS NOT SPECIFIED. THE PATIENT GOT UP TOO FAST, FELL, GOT DIZZY, LOST CONSCIOUSNESS (LOC) AND HIT THE FACE. THE CGM WAS REPORTEDLY IN THE 60'S FOR SIX HOURS UNTIL AROUND 3:30. COMPRESSION LOW WAS QUESTIONED. THE PHYSICIAN WAS NOT SURE IT WAS SEVERE HYPOGLYCEMIA. BLOOD GLUCOSE METER (BGM) WAS NOT PERFORMED DUE TO LOSS OF CONSCIOUSNESS. THE PATIENT SELF-TREATED WITH ORANGE JUICE, HE REQUIRED ASSISTANCE OF ANOTHER PERSON TO TREAT THE EVENT AND THEN, AND HE RECOVERED. PER DOCUMENTATION, IT WAS UNCLEAR WHICH BRAND CGM THE PATIENT WAS USING AND FOLLOW UP ATTEMPTS WERE REPORTEDLY UNSUCCESSFUL IN ATTEMPT TO CLARIFY. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.
Report #144 - 3004753838-2025-232440 CRITICAL
View on MAUDE
Date of Event 2025-08-05
Patient Gender Male
Patient Age 66 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON (B)(6) 2025, IT WAS REPORTED THAT AT APPROXIMATELY 6:00 PM, THE PATIENT¿S WIFE CHECKED THE PATIENT¿S BLOOD GLUCOSE USING A BLOOD GLUCOSE METER (BGM), WHICH YIELDED AN EXTREMELY HIGH RESULT (EXACT VALUE NOT PROVIDED). HOWEVER, THE PATIENT'S DEXCOM G7 CONTINUOUS GLUCOSE MONITOR (CGM) INDICATED A CRITICALLY LOW GLUCOSE LEVEL AT THE SAME TIME. THE PATIENT DID NOT TAKE ANY TREATMENT AND WENT TO BED WEARING THE DEXCOM G7 DEVICE, THOUGH THE INSERTION DATE WAS UNKNOWN. AT APPROXIMATELY 2:00 AM ON (B)(6) 2025, THE PATIENT RECEIVED A LOW GLUCOSE ALERT FROM THE CGM. IN RESPONSE, HE CONSUMED ORANGE JUICE AND COOKIES. THE PATIENT REPORTED EXPERIENCING FREQUENT LOW GLUCOSE ALERTS DURING THIS PERIOD, WHICH HE MANAGED WITH ORAL INTAKE OF ORANGE JUICE. THE PATIENT AWOKE AT 10:00 AM FEELING EXTREMELY THIRSTY AND CONTACTED A NEIGHBOR FOR ASSISTANCE, AS HE HAS RHEUMATOID ARTHRITIS AND WAS UNABLE TO RETRIEVE ORANGE JUICE ON HIS OWN. AT 3:00 PM, THE PATIENT¿S WIFE RETURNED HOME FROM WORK AND FOUND HIM UNRESPONSIVE. EMERGENCY SERVICES WERE CONTACTED, AND THE PATIENT WAS TRANSPORTED TO VERNON JUBILEE HOSPITAL. UPON ARRIVAL, HIS BLOOD GLUCOSE WAS MEASURED AT 70 MMOL/L AND CGM WAS "LOW". THE PATIENT WAS IN COMA FOR 5 DAYS AND REMAINED HOSPITALIZED AS OF THE FOLLOW-UP CALL ON (B)(6) 2025. DURING HOSPITALIZATION, THE PATIENT WAS ADMINISTERED INSULIN VIA INTRAVENOUS INFUSION. AT THE TIME OF THE REPORT THE PATIENT WAS FINE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #145 - 3004753838-2025-231223 CRITICAL
View on MAUDE
Date of Event 2025-08-05
Patient Gender Male
Patient Age 73 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT NO READINGS/BRIEF SENSOR ISSUE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ABDOMEN, WHICH IS OFF-LABEL USAGE OF THE DEVICE, ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT EXPERIENCED A SEVERE HYPOGLYCEMIC EVENT THREE DAYS AFTER SENSOR INSERTION INTO THE ABDOMEN. AT THE TIME OF THE INCIDENT, THE PATIENT WAS NOT RECEIVING ANY READINGS ON HIS CONTINUOUS GLUCOSE MONITORING SYSTEM (CGM) MOBILE DEVICE, WHICH WAS DISPLAYING A ¿BRIEF SENSOR ISSUE¿ MESSAGE. THE PATIENT¿S SPOUSE FOUND HIM UNCONSCIOUS WITH SEIZURE-LIKE ACTIVITY AND IMMEDIATELY CALLED 911. UPON ARRIVAL, EMERGENCY MEDICAL TECHNICIANS (EMTS) NOTED THE SAME SENSOR ISSUE ON THE MOBILE DEVICE AND PERFORMED A FINGERSTICK BLOOD GLUCOSE (BG) TEST, WHICH SHOWED A CRITICALLY LOW READING OF APPROXIMATELY 16-20 MG/DL. THE PATIENT WAS TREATED WITH IV FLUIDS AND TRANSPORTED TO THE HOSPITAL. AT THE HOSPITAL, THE SENSOR REMAINED IN PLACE. ONCE THE PATIENT REGAINED CONSCIOUSNESS, CGM READINGS RESUMED. NURSES MONITORED THE CGM ALONGSIDE FINGERSTICK COMPARISONS, WHICH SHOWED A CGM READING OF 281 MG/DL AND A FINGERSTICK READING OF 229 MG/DL. THE PATIENT WAS CLOSELY MONITORED FOR TWO DAYS WITH IV TREATMENT UNTIL STABILIZED. AT THE TIME OF THE REPORT, THE PATIENT WAS DESCRIBED AS ¿FINE.¿ DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS NOT CONFIRMED VIA DATA. HOWEVER, IT WAS FOUND THAT NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE UNDER AN HOUR OCCURRED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA, SEIZURE AND LOSS OF CONSCIOUSNESS.
Report #146 - 3004753838-2025-250276 CRITICAL
View on MAUDE
Date of Event 2025-08-04
Patient Gender Female
Patient Age 61 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON APPROXIMATELY (B)(6) 2025, THE PATIENT REPORTED HAVING ¿UNUSUALLY HIGH AND LOW CGM FLUCTUATIONS¿ AND THEN STARTED EXPERIENCING HAND TREMORS AND EVENTUALLY LOST CONSCIOUSNESS. NO SPECIFIC CGM VALUES WERE REPORTED AT THE TIME THE PATIENT WAS SYMPTOMATIC. PRIOR TO LOSING CONSCIOUSNESS, SHE WAS ABLE TO CALL EMERGENCY MEDICAL SERVICES (EMS). ONCE EMS ARRIVED, THE PATIENT¿S BG METER READING WAS 62 MG/DL WHILE THE CGM WAS READING HIGH. EMS TREATED THE PATIENT WITH TWO GLASSES OF ORANGE JUICE AND WITH OXYGEN. THE PATIENT DECLINED TRANSPORT TO THE EMERGENCY ROOM. THE PATIENT ¿FELT BETTER¿ AFTER TREATMENT AND WAS ¿FINE¿ AT THE TIME OF REPORT. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR WHEN THE EMT ARRIVED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #147 - 3004753838-2025-239832 CRITICAL
View on MAUDE
Date of Event 2025-08-04
Patient Gender Male
Patient Age 59 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. DATE OF EVENT IS AN APPROXIMATION. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED INACCURATE CGM READINGS AND WAS UNABLE TO RECALL ACTUAL CGM READINGS BUT THEY WERE IN NORMAL VALUES. THIS REPORT IS 3 OF 3 ALLEGATIONS OF CGM ACCURACY THAT HAD SIMILAR EVENT DETAILS. THE PATIENT PASSED OUT BUT WAS ABLE TO REGAIN CONSCIOUSNESS. THE PATIENT WASN'T FEELING GOOD AND CALLED 911 THEN AMBULANCE TOOK THE PT TO THE HOSPITAL. THE BG READING AT THE HOSPITAL WAS OVER 600 MG/DL. PT UNABLE TO REMEMBER MEDICATIONS THAT WERE ADMINISTERED AT THE HOSPITAL. THE PATIENT WAS ADMITTED TO THE ICU FOR 5 DAYS AND WAS DISCHARGED ON (B)(6) 2025. AT THE TIME OF THE REPORT THE PATIENT WAS FINE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA AND LOSS OF CONSCIOUSNESS. THIS REPORT IS 3 OF 3 ALLEGATIONS OF CGM ACCURACY THAT HAD SIMILAR EVENT DETAILS. RELATED RECORDS: (B)(4).
Report #148 - 3004753838-2025-234762 CRITICAL
View on MAUDE
Date of Event 2025-08-04
Patient Gender Male
Patient Age 14 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. AT APPROXIMATELY 5:00PM, THE PEDIATRIC PATIENT HAD CRAMP ATTACKS [PRESUMED TO MEAN SEIZURES] AND FELL DOWN FROM HIS BED. THE PATIENT'S PARENT FOUND THE PATIENT ON THE FLOOR UNCONSCIOUS WITH FOAM IN HIS MOUTH AND CALLED AN AMBULANCE. PRIOR TO THE AMBULANCE ARRIVING, THE PATIENT'S PARENT GAVE THE PATIENT GRAPE SUGAR AND THE PATIENT REGAINED CONSCIOUSNESS. AFTER AMBULANCE ARRIVED 20 MINUTES LATER, A BLOOD GLUCOSE WAS CHECKED AND IT SHOWED AN UNDETERMINED LOW BLOOD SUGAR LEVEL. THEY TRANSPORTED THE PATIENT TO THE HOSPITAL AND THE PATIENT WAS TREATED WITH IV GLUCOSE AND FOOD. AT 9:30PM, THE PATIENT FELT GOOD AND WENT HOME. DATA WAS PROVIDED FOR EVALUATION. A REVIEW OF PERFORMANCE DATA FOUND THAT THE PATIENT'S LOW ALERT WAS NEVER BREACHED AT THE ALLEGED TIME OF THE INCIDENT ON (B)(6) 2025. DATA INVESTIGATION FOUND THAT THE PATIENT'S ESTIMATED GLUCOSE VALUES WERE AROUND 140 MG/DL AT 5:00 AM WHEN THE HYPOGLYCEMIC EVENT REPORTEDLY OCCURRED. THUS, INACCURATE ESTIMATED GLUCOSE VALUES HAVE BEEN DETERMINED TO BE THE MOST LIKELY THE PROBABLE CAUSE OF THE HYPOGLYCEMIC EVENT. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #149 - 3004753838-2025-228268 CRITICAL
View on MAUDE
Date of Event 2025-08-04
Patient Gender Male
Patient Age 72 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN UNSPECIFIED MALFUNCTION OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA PRIOR TO PASSING OUT. AT THE TIME OF THE EVENT, THE PATIENT WAS UNABLE TO RECALL THEIR CGM AND BLOOD GLUCOSE READINGS AND REFUSED TO PROVIDE FURTHER EVENT DETAILS. NO DATA OR PRODUCT WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED.
Report #150 - 3004753838-2025-246406 CRITICAL
View on MAUDE
Date of Event 2025-08-03
Patient Gender Male
Patient Age 68 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ACCORDING TO THE PATIENT, ON (B)(6) 2025, WHILE THE PATIENT WAS ON HOLIDAY IN TURKEY, HIS BG DECREASED TO 18 MG/DL WHILE THE CGM READING WAS 78 MG/DL. IT WAS REPORTED THAT THE PATIENT ¿ALMOST DIED¿ BUT NO SPECIFIC SYMPTOMS WERE DOCUMENTED. HIS DAUGHTER ADMINISTERED A GLUCOSE INJECTION (MEANT TO BE GLUCAGON) AND CALLED AN AMBULANCE AND WAS TAKEN TO A PRIVATE HOSPITAL. THE PATIENT WAS DISCHARGED THE SAME DAY LATER THAT EVENING WHEN HIS BG ROSE TO 300 MG/DL. AT THE TIME OF THE REPORT THE PATIENT WAS WELL. THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.
Report #151 - 3004753838-2025-240773 CRITICAL
View on MAUDE
Date of Event 2025-08-02
Patient Gender Female
Patient Age 79 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ACCORDING TO THE PATIENT, ON APPROXIMATELY (B)(6) 2025, THE CGM READING WAS 212 MG/DL, AND THE PATIENT SELF-TREATED WITH INSULIN. NO FINGERSTICK WAS TAKEN AT THAT TIME, BUT AFTER SELF-TREATMENT THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS. NO TREATMENT WAS REPORTED, BUT AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #152 - 3004753838-2025-230301 CRITICAL
View on MAUDE
Date of Event 2025-08-02
Patient Gender Female
Patient Age NA
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). | THE COMPLAINT STATES THAT "CGM ACCURACY" WAS REPORTED. ON (B)(6) 2025, IT WAS REPORTED VIA SPRINKLR THAT THE PATIENT EXPERIENCED A CGM ACCURACY ISSUE WHERE THEY REPORTED THAT THE ¿FALSE READINGS¿ FROM THE CGM DEVICE ¿ALMOST PUT HER IN A COMA¿. NO OTHER EVENT DETAILS WERE REPORTED, INCLUDING MEDICATION OR TREATMENT DETAILS. NO OTHER PATIENT OR EVENT DETAILS WERE AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. PROBLEM COULD NOT BE CONFIRMED AND PROBABLE CAUSE CANNOT BE DETERMINED. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | . DIABETES MELLITUS IS A KNOWN CAUSE OF LOSS OF CONSCIOUSNESS. | SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION BECAME AVAILABLE.
Report #153 - 3004753838-2025-231218 CRITICAL
View on MAUDE
Date of Event 2025-08-02
Patient Gender Female
Patient Age 62 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE DATE OF EVENT IS AN APPROXIMATION. ON 08/02/2025, THE PATIENT EXPERIENCED A SEVERE HYPOGLYCEMIC EVENT WHILE ALONE AT HOME. SHE MEASURED HER BG USING A METER, WHICH SHOWED A READING OF 50 MG/DL, WHILE BOTH HER CGM RECEIVER AND MOBILE DEVICE DISPLAYED AN ESTIMATED GLUCOSE VALUE (EGV) OF 400 MG/DL. DURING THIS TIME, THE PATIENT BECAME INCOHERENT AND SUBSEQUENTLY LOST CONSCIOUSNESS. HER HUSBAND WAS ALERTED AND CALLED 911. PARAMEDICS ARRIVED AND ADMINISTERED D50 TREATMENT. THE PATIENT WAS NOT TRANSPORTED TO A HOSPITAL AND REMAINED AT HOME. AT THE TIME OF THE REPORT, SHE WAS RECOVERING. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #154 - 3004753838-2025-255176 CRITICAL
View on MAUDE
Date of Event 2025-08-01
Patient Gender Female
Patient Age 42 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. ON (B)(6) 2025, THE PATIENT WAS FOUND LYING IN BED, UNRESPONSIVE, WHILE HER CHILDREN TRIED TO WAKE HER. THEY QUICKLY CALLED FOR EMERGENCY ASSISTANCE. THE PARAMEDICS ARRIVED AND DISCOVERED SHE WAS EXPERIENCING HYPOGLYCEMIA. HER BLOOD SUGAR WAS MEASURED AT 28 MG/DL. SHE WAS TAKEN TO THE HOSPITAL, WHERE SHE WAS PROVIDED IV GLUCOSE AND FOOD, WITH NO MEDICATIONS GIVEN. SHE DID NOT REMEMBER HEARING ANY ALERTS FROM THE CGM DURING THIS INCIDENT. THE PATIENT COULD NOT REMEMBER THE CGM VALUE BEFORE AND WHILE SHE WAS AT THE HOSPITAL OR HOW LONG SHE WAS UNCONSCIOUS. THE PATIENT STATED THAT THE RECEIVER'S SPEAKER WORKED FINE; HOWEVER, SHE WAS UNCERTAIN IF THE RECEIVER ALERTED AND RANG DURING THE EVENT. AT THE TIME OF THE REPORT, THE PATIENT WAS DOING BETTER. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION AND PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.
Report #155 - 3004753838-2025-239038 CRITICAL
View on MAUDE
Date of Event 2025-08-01
Patient Gender Male
Patient Age 47 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA AND LOSS OF CONSCIOUSNESS. H6 CODES: HEALTH EFFECT - CLINICAL CODE PROBLEM CODE: E1907 VIRAL INFECTION/ CODE NOT AVAILABLE. H6 CODES: HEALTH EFFECT - CLINICAL CODE PROBLEM CODE : CORRECTION TO DISREGARD 4581 APPROPRIATE TERM/CODE NOT AVAILABLE. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT BEGAN EXPERIENCING SYMPTOMS CONSISTENT WITH SEVERE FLU, INCLUDING VOMITING, WHICH MAY HAVE CONTRIBUTED TO ELEVATED GLUCOSE READINGS. AT APPROXIMATELY 10:00 A.M., THE PATIENT LOST CONSCIOUSNESS. HE WAS UNABLE TO RECALL THE CGM (G6) READINGS AT THE TIME, AND NO FINGERSTICK TEST WAS PERFORMED. THE PATIENT ALLEGED RECEIVING ONLY A ¿HIGH¿ ALERT FROM THE CGM DEVICE AND EXPRESSED UNCERTAINTY ABOUT THE ACCURACY OF THE READING, NOTING HE WAS UNABLE TO VERIFY IT MANUALLY DUE TO HAVING PASSED OUT. THE PATIENT¿S PARENTS CALLED EMERGENCY SERVICES. NO BLOOD GLUCOSE READINGS WERE REPORTED BY EMS. UPON ARRIVAL AT THE HOSPITAL, THE PATIENT REGAINED CONSCIOUSNESS. THE ATTENDING PHYSICIAN REMOVED THE PATIENT¿S SENSOR AND TRANSMITTER. THE PATIENT SUSTAINED A KNEE INJURY FROM THE FALL AND UNDERWENT AN MRI ON THE SAME DAY. HE WAS TREATED WITH INSULIN AND ADMITTED TO THE HOSPITAL FOR SIX DAYS. THE PATIENT WAS DISCHARGED ON (B)(6) 2025, AROUND 12:00 P.M., AND REPORTED FEELING BETTER AT THE TIME OF THE FOLLOW-UP. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #156 - 3004753838-2025-232730 CRITICAL
View on MAUDE
Date of Event 2025-08-01
Patient Gender Male
Patient Age 41 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4) DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA, SEIZURE AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON (B)(6) 2025, THE PATIENT WAS FOUND UNRESPONSIVE AND EXPERIENCING A SEIZURE ON THE BEDROOM FLOOR BY HIS FATHER, WHO IMMEDIATELY CONTACTED EMERGENCY SERVICES. THE PATIENT WAS TRANSPORTED TO THE INTENSIVE CARE UNIT (ICU), WHERE HE REMAINED FOR FOUR DAYS. PRIOR TO THE SEIZURE, THE PATIENT RECALLED THAT HIS DEXCOM CGM DISPLAYED A GLUCOSE READING OF 90 MG/DL, WHILE HIS BG METER SHOWED A VALUE OF 50 MG/DL. THE PATIENT WAS UNABLE TO CONFIRM WHETHER PARAMEDICS OR HOSPITAL STAFF CONDUCTED A COMPARISON BETWEEN THE DEXCOM AND BG METER READINGS DURING OR AFTER THE INCIDENT. ACCORDING TO THE ATTENDING PHYSICIAN, THE SEIZURE WAS ATTRIBUTED TO HYPOGLYCEMIA. THE PATIENT DID NOT RECALL RECEIVING ANY SPECIFIC MEDICATIONS DURING HIS HOSPITALIZATION. HE WAS DISCHARGED ON (B)(6) 2025, AND AT THE TIME OF REPORTING, THE PATIENT WAS OKAY. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #157 - 3004753838-2025-230150 CRITICAL
View on MAUDE
Date of Event 2025-07-30
Patient Gender Male
Patient Age 58 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM. ACCORDING TO THE PATIENT, ON (B)(6) , 2025, THE PATIENT EXPERIENCED A HEADACHE, LOSS OF CONSCIOUSNESS AND FELL. AN AMBULANCE WAS CALLED AND WHEN A FINGERSTICK WAS TAKEN THE BLOOD GLUCOSE READING WAS 19 MG/DL. NO CGM READING WAS REPORTED, BUT IT WAS UNDERSTOOD THAT THE PATIENT ALLEGED THIS WAS INACCURATE AT THE TIME OF THE EVENT. THE PATIENT REGAINED CONSCIOUSNESS AT THE HOSPITAL AND COULD NOT REMEMBER ANY MEDICATION GIVEN. IT WAS NOT KNOWN HOW LONG THE PATIENT WAS AT THE HOSPITAL FOR, BUT IT WAS STATED THAT THE PATIENT WAS ¿HOSPITALIZED¿ FOR STABILIZE BLOOD SUGAR LEVELS. THE PATIENT EXPERIENCED A BLACK EYE DUE TO THE FALL. THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #158 - 3004753838-2025-255148 CRITICAL
View on MAUDE
Date of Event 2025-07-28
Patient Gender Female
Patient Age 42 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. ON APPROXIMATELY (B)(6) 2025, THE PATIENT WAS LYING IN BED AT HOME WHEN HER CHILDREN NOTICED SOMETHING WAS WRONG BECAUSE SHE WASN¿T RESPONDING TO THEM. CONCERNED, THEY CALLED FOR HELP. PARAMEDICS ARRIVED AND FOUND HER UNCONSCIOUS, SUFFERING FROM SEVERE HYPOGLYCEMIA. HER BLOOD SUGAR LEVEL WAS CRITICALLY LOW AT 28 MG/DL. SHE DIDN¿T RECALL HEARING ANY ALERTS FROM HER CGM AT THE TIME AND A BLOOD GLUCOSE METER READING WAS NOT CHECKED. SHE WAS TAKEN TO THE HOSPITAL WHERE SHE WAS TREATED WITH INTRAVENOUS GLUCOSE AND GIVEN FOOD TO HELP STABILIZE HER CONDITION. NO MEDICATIONS WERE ADMINISTERED DURING THIS EVENT. THE PATIENT COULD NOT REMEMBER THE CGM VALUE PRIOR TO LOSING CONSCIOUSNESS AND SHE COULD NOT REMEMBER HOW LONG SHE REMAINED UNCONSCIOUS. THE PATIENT MENTIONED THAT THE RECEIVER'S SPEAKER WORKED FINE HOWEVER SHE WAS UNCERTAIN IF THE RECEIVER ALERTED AND RANG AS SHE DID NOT HEAR ANYTHING. THE PATIENT STAYED IN THE HOSPITAL FOR 24 HOURS. AT THE TIME OF THE REPORT, THE PATIENT WAS DOING BETTER. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION AND PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.
Report #159 - MW5175607 CRITICAL
View on MAUDE
Date of Event 2025-07-28
Patient Gender Female
Patient Age 78 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITOR (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
I USE A TANDEM T-SLIM INSULIN PUMP AND FOR SEVERAL YEARS USED A DEXCOM G6 CONTINUOUS GLUCOSE MONITOR (CGM). I AM ON (B)(6) AND KEPT GETTING NOTICES THE G6 WOULD BE PHASED OUT AND I SHOULD USE THE NEW G7. I SWITCHED TO THE G7 AND BEGAN HAVING PROBLEMS WITH THE CGM LOSING BLUETOOTH CONNECTION WITH MY PUMP. AFTER MONTHS OF PROBLEMS, MY ENDOCRINOLOGIST SWITCHED ME TO ABBOTT FREESTYLE LIBRE 2+. THIS CGM AS WORSE THAN THE G7. IT WAS "OUT OF RANGE" 30-40% OF THE TIME. THIS OCCURRED REPEATEDLY OVERNIGHT. WHEN OUT OF RANGE OCCURS, THE CONTROL IQ SOFTWARE IN THE TANDEM PUMP DOESN'T WORK. CONTROL IQ RAISES OR LOWERS THE BASAL RATE OF INSULIN DELIVERED BY THE PUMP. THIS KEEPS THE USER FROM HAVING BLOOD GLUCOSE LEVELS THAT ARE TOO HIGH OR TOO LOW -- THIS SITUATION IS BAD FOR A DIABETIC. I MADE REPEATED CALLS TO DEXCOM ABOUT THEIR CGM AND TO TANDEM ABOUT MY PUMP. TANDEM SENT ME A REPLACEMENT PUMP ON (B)(6) 2025. WITHIN 30 MINS. OF THE STARTUP OF THE NEW PUMP, THE OUT OF RANGE OCCURRED WITH THE ABBOTT CGM. THE TANDEM REP FOR SAN ANTONIO CAME TO MY HOME THE FOLLOWING WEEK AND INTERVIEWED ME FOR 1.5 HOURS. HE WAS EXTREMELY HELPFUL IN TRYING TO RESOLVE MY ISSUES, BUT HIS SUGGESTIONS DID NOT WORK. ON (B)(6) 2025, I INSERTED A DEXCOM G6 CGM GIVEN TO ME BY MY DIABETES CLINIC. IT LASTS FOR 10 DAYS. IT WORKED FOR SEVERAL CONSECUTIVE DAYS WITHOUT A BREAK, BUT THEN BEGAN TO HAVE DISCONNECTION PROBLEMS. I WILL STICK WITH THE G6 AS LONG AS DEXCOM PRODUCES IT BECAUSE THE TRANSMITTER IS STRONGER AND MORE RELIABLE. DEXCOM MAY HAVE OPTED FOR A CHEAPER, POORER QUALITY FILAMENT/NEEDLE THAT RESIDES IN YOUR ARM. I DON'T KNOW. BUT, AS A TYPE 1 DIABETIC FOR 20 YEARS (WITH MOST OF THEM ON A PUMP), AND A SON WITH DIABETES (T1D) FOR 39 YEARS, I KNOW DIABETES AND I KNOW PUMPS. IN (B)(6) 2020, I PARTICIPATED IN AN ENDEAVOR CLINICAL TRIAL FOR DEXCOM. I WORE 5 CGM SENSORS IN MY BODY FOR OVER 3 WEEKS. NONE OF THEM LOST CONNECTION -- NOT ONCE. I KNOW DEXCOM CAN DO BETTER. I AM 78 YEARS OLD AND KNOW I AM CLOSER TO THE END OF MY LIFE THAN MANY FOLKS; HOWEVER, THERE ARE PARENTS WITH INFANTS AND YOUNG CHILDREN WHO ARE STRUGGLING EVERY DAY TRYING TO KEEP THEIR DIABETIC CHILD ALIVE AND MINIMIZE THE HORRIFIC SIDE EFFECTS OF BLOOD GLUCOSE LEVELS THAT ARE OUT OF RANGE. YOU ONLY HAVE TO READ A FEW OF THE COMMENTS ON THE FACEBOOK PAGE OF DEXCOM G7 COMPLAINTS TO SEE THE NIGHTMARE SCENARIOS THESE PEOPLE ARE EXPERIENCING. A PRODUCT SHOULD WORK AS ADVERTISED -- ESPECIALLY WHEN SAID PRODUCT IS PRODUCED/SOLD TO HELP A SERIOUS, POSSIBLY LIFE-THREATENING DISEASE. I WOULD NOT LIKE TO THINK THAT THESE COMPANIES ARE MAKING DECISIONS THAT SEEK TO ENHANCE THEIR FINANCIAL BOTTOM LINES, BUT ONE WONDERS. IF EARLIER GENERATIONS OF A PRODUCT WORKED BETTER, WHAT HAS HAPPENED? I WORE THE FIRST GENERATION OF THE DEXCOM CGM. IT WAS NOT VERY ACCURATE, BUT IT WAS A STEP IN THE RIGHT DIRECTION. DEXCOM HAS TAKEN MANY STEPS BACKWARD. THIS IS A SERIOUS ISSUE FOR DIABETICS WHO WEAR PUMPS AND/OR USE CONTINUOUS GLUCOSE MONITORS. WHEN YOU CALL DEXCOM OR ABBOTT FOR TECHNICAL ASSISTANCE, YOU SPEAK TO A PERSON WHO IS READING FROM A SCRIPT AND YOU DON'T GET THE SAME ANSWER TWICE. A REP AT ABBOTT TOLD ME THE PROBLEM WAS WITH THE CURRENT IOS VERSION ON MY IPHONE, WHERE I HAVE AN APP THAT CONNECTS TO MY PUMP AND CGM. SHE OBVIOUSLY DOES NOT KNOW HER PRODUCT. THE ONLY TIME THE IPHONE IS USED IS WHEN YOU INSERT A NEW ABBOTT CGM AND YOU SCAN THE DEVICE WITH THE IPHONE TO PAIR IT WITH YOUR PUMP. THEN, THE IPHONE IS OUT OF THE EQUATION -- COMMUNICATION IS BETWEEN THE PUMP AND CGM. NOT VERY HELPFUL. I FEEL I HAVE A LOT OF EXPERIENCE WITH PUMPS AND CGMS, BUT THIS ISSUE HAS BECOME EXTREMELY FRUSTRATING FOR ME. DIABETES REQUIRES A LOT OF ATTENTION, BUT I FEEL LIKE THESE PROBLEMS HAVE TAKEN OVER MY WHOLE LIFE AND HAVE CERTAINLY AFFECTED THE QUALITY OF LIFE FOR ME. PLEASE LET ME KNOW WHAT IS BEING DONE TO INVESTIGATE AND CORRECT THESE PROBLEMS THAT MANY CGM USERS ARE EXPERIENCING. THANK YOU FOR YOUR TIME. DEVICE CODES: 3283, 2880, 1506. PATIENT CODES: 4580. REFERENCE REPORT MW5175608.
Report #160 - 3004753838-2025-244407 CRITICAL
View on MAUDE
Date of Event 2025-07-28
Patient Gender Female
Patient Age 60 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. | IT WAS REPORTED THAT AN UNSPECIFIED MALFUNCTION OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON APPROXIMATELY (B)(6) 2025, THE PATIENT WAS FOUND UNCONSCIOUS ON THE FLOOR AFTER PASSING OUT AT HOME. SOMEONE WHO KNEW THE PATIENT HEARD HER GROANING AND CALLED 911. SHE WAS TRANSPORTED BY EMERGENCY MEDICAL SERVICES (EMS) TO THE HOSPITAL AND ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT REPORTED THAT SHE WAS UNSURE IF HER DEXCOM DEVICE WAS FUNCTIONING OR RECORDING AT THE TIME OF THE EVENT AND DID NOT KNOW WHAT HER BLOOD GLUCOSE LEVEL WAS WHEN SHE LOST CONSCIOUSNESS. SHE ALSO WAS UNSURE IF HER BLOOD GLUCOSE WAS TESTED AND WHAT THE RESULT WAS WHEN EMS ARRIVED. ADDITIONALLY, SHE COULD NOT RECALL THE LAST DEXCOM READING PRIOR TO THE EVENT. AT THE TIME OF THE REPORT, THE PATIENT REMAINED ADMITTED TO THE HOSPITAL. SHE STATED THAT SHE WAS GIVEN MEDICATION DURING HER HOSPITALIZATION BUT DID NOT KNOW WHAT SPECIFIC MEDICATION WAS ADMINISTERED. THERE WAS NO MENTION OF WHETHER THE INCIDENT WAS DUE TO A DEXCOM MALFUNCTION OR ANOTHER CAUSE. AT THE TIME OF THE REPORT, THE PATIENT WAS DOING OKAY. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. PROBLEM COULD NOT BE CONFIRMED AND PROBABLE CAUSE CANNOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #161 - 3004753838-2025-237178 CRITICAL
View on MAUDE
Date of Event 2025-07-28
Patient Gender Male
Patient Age 22 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA, SEIZURE AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM, WHICH IS OFF-LABEL USAGE OF THE DEVICE. ON (B)(6) 2025, THE PATIENT EXPERIENCED A SEIZURE AND BECAME UNRESPONSIVE AT HOME SHORTLY AFTER A CGM SENSOR WAS PLACED ON THE ARM. THE PATIENT'S GIRLFRIEND CHECKED THE DEXCOM MOBILE DEVICE, WHICH SHOWED A READING OF 80 MG/DL. A FINGERSTICK (FS) TEST WAS PERFORMED, SHOWING THE BLOOD GLUCOSE LEVEL OF 30 MG/DL. EMERGENCY SERVICES WERE CONTACTED, AND UPON ARRIVAL, PARAMEDICS CONFIRMED A BLOOD GLUCOSE LEVEL OF 44 MG/DL VIA THEIR OWN TESTING. NO CGM READINGS WERE MENTIONED OR VERIFIED BY THE PARAMEDICS FOR COMPARISON. THE PATIENT RECEIVED INTRAVENOUS TREATMENT (SPECIFIC MEDICATION NOT REPORTED) TO STABILIZE BLOOD GLUCOSE LEVELS. AT SOME POINT THE PATIENT REGAINED CONSCIOUSNESS AND WAS STABILIZED. THE FOLLOWING DAY, THE PATIENT FOLLOWED UP WITH THEIR DIABETES CARE PROVIDER TO DISCUSS THE EVENT. AT THE TIME OF THIS REPORT, THE PATIENT IS REPORTED TO BE DOING WELL. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #162 - 3004753838-2025-235803 CRITICAL
View on MAUDE
Date of Event 2025-07-28
Patient Gender Male
Patient Age 78 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM, WHICH IS OFF-LABEL USAGE OF THE DEVICE, ON (B)(6) 2025. THE DATE OF EVENT IS AN APPROXIMATION. ON (B)(6) 2025, THE PATIENT HAD STOKE-LIKE SYMPTOMS. THE PATIENT REPORTED A CGM DISCREPANCY WHERE THE DEVICE INDICATED A LEVEL OF APPROXIMATELY 170 MG/DL, WHILE A FINGERSTICK READING SHOWED 39 MG/DL. THE PATIENT STATED HE ENDED UP IN THE EMERGENCY ROOM (ER) DUE TO THIS EVENT. WHILE HOSPITALIZED, THE CGM AGAIN DISPLAYED A READING OF 198 MG/DL, WHILE A BLOOD DRAW CONFIRMED A BG LEVEL OF 39 MG/DL. THE PATIENT FURTHER SHARED AT AN UNSPECIFIED TIME THAT HIS PUMP SHOWED 188 MG/DL, BUT HE BELIEVED HIS ACTUAL BG WAS IN THE 20S, DESCRIBING THE EVENT AS NEARLY RESULTING IN A COMA. HE CONFIRMED THAT HE WENT TO THE ER ON (B)(6) 2025. THE PATIENT WENT TO THE ER BECAUSE HE WAS EXPERIENCING LOW BG AND WANTED TO UNDERSTAND WHAT WAS HAPPENING. NO SYMPTOMS WERE REPORTED BY THE PATIENT, BUT THE SPOUSE MENTIONED HE HAD EXPERIENCED A TRANSIENT ISCHEMIC ATTACK (TIA). THIS WAS ALSO THE TIME WHEN THE BG WAS CONFIRMED AT 39 MG/DL VIA BLOOD DRAW, WHILE THE PUMP SHOWED 198 MG/DL. TREATMENT ADMINISTERED IN THE ER INCLUDED AN IV WITH SUGAR WATER, AND THE PATIENT WAS DISCHARGED THE SAME DAY. HE WAS THEN SENT HOME IN THE AFTERNOON WHEN HIS BLOOD SUGAR LEVELED, AND HE CHANGED THE SENSOR WHEN HE GOT HOME. AT THE TIME OF THE REPORT, THE PATIENT WAS OKAY. ALTHOUGH ADDITIONAL ATTEMPTS WERE MADE TO OBTAIN CLARIFICATION OF EVENT DETAILS, NO REPLY HAS BEEN RECEIVED. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D AND E ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #163 - 3004753838-2025-232892 CRITICAL
View on MAUDE
Date of Event 2025-07-28
Patient Gender N/A
Patient Age N/A
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON (B)(6) 2025, THE PATIENT CHECKED HIS CGM, WHICH APPEARED TO SHOW NORMAL READINGS. HOWEVER, SHORTLY AFTER CONSUMING A ROUTINE MEAL, THE PATIENT LOST CONSCIOUSNESS. EMERGENCY MEDICAL SERVICES (EMS) ARRIVED WHILE THE PATIENT REMAINED UNCONSCIOUS FOR APPROXIMATELY ONE HOUR. AT THAT TIME, THE CGM WAS DISPLAYING ¿LOW¿ AND NOT RETURNING NUMERIC DATA. EMS PERFORMED A MANUAL BG TEST, WHICH REVEALED A LOW GLUCOSE LEVEL OF 25 MG/DL. THE PATIENT WAS TREATED WITH INTRAVENOUS GLUCOSE SOLUTION. THE PATIENT WAS ADMITTED TO THE HOSPITAL AT APPROXIMATELY 3:00 PM AND DISCHARGED AROUND 9:00 PM THE SAME DAY. AT THE TIME OF REPORTING, THE PATIENT WAS FEELING OKAY AND HAD HIRED A PRIVATE NURSE TO MONITOR HIS HEALTH DAILY AND ENSURE PROPER PLACEMENT AND USE OF THE CGM DEVICE. PRIOR TO REPLACING THE SENSOR, THE PATIENT CONTINUED TO EXPERIENCE INACCURATE READINGS. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). | SUBSEQUENT TO THE INITIAL MDR, A CORRECTION WAS UPDATED ON 08/21/2025. IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #164 - 3004753838-2025-242855 CRITICAL
View on MAUDE
Date of Event 2025-07-27
Patient Gender Female
Patient Age 71 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ABDOMEN, WHICH IS OFF-LABEL USAGE OF THE DEVICE. ON APPROXIMATELY (B)(6) 2025, AROUND 4AM, THE PATIENT WAS AWAKENED BY A LOW ALERT ON HER CGM AND A VALUE OF 80 MG/DL. NO BG METER COMPARISON VALUE WAS REPORTED. THE PATIENT WAS WEARING A TANDEM INSULIN PUMP. THE PATIENT WENT DOWNSTAIRS TO GET SOME APPLE OR ORANGE JUICE FOR TREATMENT. THE NEXT THINGS THAT HAPPENED WAS THE PATIENT FELL, HIT HER HEAD ON THE COUNTER, AND LOST CONSCIOUSNESS FOR APPROXIMATELY 45 MINUTES. ONCE THE PATIENT REGAINED CONSCIOUSNESS ON HER OWN, THE PATIENT FOUND HER HUSBAND AND HE TOOK HER TO THE EMERGENCY ROOM. AT THE ER, THE PATIENT¿S BG METER READING WAS 60 MG/DL. NO CGM COMPARISON VALUE WAS REPORTED AT THIS TIME. THE PATIENT WAS TREATED WITH IV GLUCOSE. SHE ALSO HAD STAPLES PUT ON HER HEAD LACERATION. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY (SPECIFIC HOURS IN THE ER WERE NOT REPORTED). THE PATIENT WAS "STABLE" AT THE TIME OF REPORT. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #165 - 3004753838-2025-233826 CRITICAL
View on MAUDE
Date of Event 2025-07-26
Patient Gender Female
Patient Age 66 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON APPROXIMATELY 07/26/2025, THE CGM WAS SHOWING APPROXIMATELY 300 MG/DL. BASED ON THE CGM READING, THE PATIENT ADMINISTERED 2 UNITS OF NOVOLOG. SHORTLY AFTER, SHE BEGAN TO SHAKE. A MANUAL BG WAS CHECKED AND IT WAS AROUND 55 MG/DL. SHE ATE CARBOHYDRATES AND DRANK ORANGE JUICE TO ATTEMPT TO INCREASE HER BG BUT THERE WAS NO IMPROVEMENT AND SHE EVENTUALLY PASSED OUT. HER HUSBAND CALLED 911 AND WHEN AMBULANCE ARRIVED, THEY "REVIVED" HER AND SHE REGAINED CONSCIOUSNESS (NO INFORMATION ABOUT TREATMENT PROVIDED TO "REVIVE" THE PATIENT). SHE WAS TRANSPORTED TO THE EMERGENCY ROOM. THERE WAS NO FURTHER INFORMATION PROVIDED ABOUT THE ER VISIT. AT THE TIME OF THE REPORT, THE PATIENT WAS FEELING FINE. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #166 - 3004753838-2025-232598 CRITICAL
View on MAUDE
Date of Event 2025-07-26
Patient Gender N/A
Patient Age N/A
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). | SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION HAS BEEN PROVIDED. DATA WAS PROVIDED FOR INVESTIGATION. THE PATIENT BEGAN TO DECREASE IN EGV'S FROM NOON TO 1 PM WITH EGVS FROM 128 - 72 MG/DL. FROM 1:05 - 1:15 PM THE PATIENT WAS NEAR THEIR LOW THRESHOLD BETWEEN 66 - 61 MG/DL. AT 1:20 PM THE PATIENT GOT A LOW ALERT TO THEIR BLUETOOTH DEVICE AT 35 % VOLUME. THE LOW ALERT CLEARED AT THE FOLLOWING EGV SINCE THEY CLEARED THEIR LOW THRESHOLD WITH A VALUE OF 61 MG/DL. AFTER 1:30 PM, THE PATIENT'S EGVS BEGAN TO RISE. THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. | IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. ACCORDING TO THE PATIENT, ON APPROXIMATELY (B)(6) 2025, WHILE AT WORK, THE PATIENT BECAME UNABLE TO RESPOND TO OTHER¿S QUESTIONS AND EVENTUALLY LOST CONSCIOUSNESS. THE PATIENT¿S CGM WAS READING 45 MG/DL, HOWEVER, THE PATIENT REPORTED NOT RECEIVING AN ALERT FROM HIS MOBILE APP TO NOTIFY HIM OF HIS HYPOGLYCEMIC STATE. NO BG METER READING WAS REPORTED. A CO-WORKER RECOGNIZED SOMETHING WAS WRONG WITH THE PATIENT AND CALLED EMERGENCY MEDICAL SERVICES (EMS). ONCE EMS ARRIVED, THE PATIENT WAS TREATED WITH AN UNSPECIFIED INJECTION AND WAS TRANSPORTED TO THE EMERGENCY ROOM (ER). AT SOME POINT AT THE ER, THE PATIENT REGAINED CONSCIOUSNESS AND RECALLED HIS BG METER READING DROPPED TO 40 MG/DL. THE PATIENT WAS TREATED WITH AN UNSPECIFIED IV, GUM, CRACKERS, AND JUICE. THE PATIENT WAS DISCHARGED HOME AFTER APPROXIMATELY 2 HOURS ONCE HIS BG LEVEL INCREASED TO 100 MG/DL. THE PATIENT WAS ¿OKAY¿ AT THE TIME OF REPORT. DATA HAS BEEN REQUESTED BUT IS PENDING EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #167 - 3004753838-2025-232242 CRITICAL
View on MAUDE
Date of Event 2025-07-25
Patient Gender Male
Patient Age 22 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT'S G7 APP WAS SHOWING 385 MG/DL (NO BG WAS NOT CHECKED) AND THE PATIENT PASSED OUT. BYSTANDERS GAVE GLUCOSE GEL AND HE STILL WASN'T ABLE TO REGAIN CONSCIOUSNESS. SO THE CO WORKERS CALLED 911 AND THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM. WHILE IN THE AMBULANCE, THE PARAMEDICS AT THE AMBULANCE GOT A BG METER READING OF 55 MG/DL (THE CGM WAS UNKNOWN AT THIS TIME). IN THE EMERGENCY DEPARTMENT (ED), THE BG WAS 120 MG/DL. THE PARAMEDICS AT EMERGENCY ROOM GAVE HIM SOME DEXTROSE THROUGH IV AND EVENTUALLY HE WAS ABLE TO REGAIN CONSCIOUSNESS. HE WAS AT THE EMERGENCY ROOM FOR ABOUT 2 HOURS. HE ATE AND THE BG WAS 180 MG/DL. HE WAS DISCHARGED ABOUT 5:00. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #168 - 3004753838-2025-228194 CRITICAL
View on MAUDE
Date of Event 2025-07-25
Patient Gender Female
Patient Age 88 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. ACCORDING TO THE PATIENT, ON APPROXIMATELY (B)(6) 2025, THE PATIENT DID NOT RECEIVE ANY ALERT LETTING HER KNOW THAT HER BLOOD GLUCOSE (BG) WAS DROPPING PAST HER ALERT THRESHOLD. THE PATIENT WAS SITTING ON HER COUCH WHEN SUDDENLY SHE HEARD AN ALERT FROM HER CONTINUOUS GLUCOSE MONITOR (CGM), LETTING HER KNOW THAT SHE'S GETTING A LOW READING OF 40 MG/DL. THE PATIENT DIDN'T EXPERIENCE ANY SYMPTOMS OF LOW PRIOR TO OR AFTER GETTING THIS READING OF 40 MG/DL. THE PATIENT DID NOT PERFORM A FINGERSTICK TO CHECK HER BG. IN AN ATTEMPT TO SELF-TREAT, THE PATIENT STOOD UP TO GRAB A CUP OF CHOCOLATE MILK AND SUDDENLY PASSED OUT AND HIT HERSELF ON THE DRESSER. THE PATIENT HAD A CUT AND BRUISE ON HER ARM AS WELL AS A BRUISE ON HER BACK FROM THE FALL. A VISITOR HAPPENED TO COME BY HER HOME AND SAW HER LYING ON THE FLOOR AND HELPED HER GET UP. THE PATIENT STATED THAT SHE WAS NOT UNCONSCIOUS FOR VERY LONG AND DID NOT SEEK ANY MEDICAL ATTENTION. THE PATIENT DID NOT TAKE ANY MEDICATION AS WELL. SHE TOOK HONEY, WARM WATER, AND ONE CUP OF CHOCOLATE MILK, AND WAS FEELING BETTER AFTER. AT THE TIME OF THE REPORT, THE PATIENT WAS FEELING FINE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.
Report #169 - 3004753838-2025-228295 CRITICAL
View on MAUDE
Date of Event 2025-07-25
Patient Gender Female
Patient Age 62 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ACCORDING TO THE PATIENT, (B)(6) 2025, SHE FELT DIZZY WHILE THE CGM DISPLAYED 92MG/DL, NO FINGERSTICK WAS DONE AT THAT TIME. THE PATIENT HAD AN APPLE SAUCE TO BRING HER SUGAR UP AND LOSS CONSCIOUSNESS. THE PATIENT¿S SON FOUND HER UNCONSCIOUS AND CALLED FOR AN AMBULANCE. THE PATIENT REGAINED CONSCIOUSNESS AFTER ARRIVING AT THE HOSPITAL. PRIOR TO ARRIVAL TO THE HOSPITAL THE SENSOR WAS REMOVED. THE PATIENT WAS TREATED WITH SUGAR WATER THROUGH DEXTROSE AND GLUCAGON WHILE IN THE HOSPITAL. THE PATIENT IS UNABLE TO RECALL HER BG VALUES TAKEN BY THE HOSPITAL PERSONNEL, BUT SHE SAID AT ONE POINT HER BG WAS 33 MG/DL. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2025 AND THE BG WAS 112MG/DL. NO FURTHER MEDICATION OR INTERVENTION WAS REQUIRED. AT THE TIME OF THE REPORT, THE PATIENT WAS FEELING FINE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #170 - 3004753838-2025-240803 CRITICAL
View on MAUDE
Date of Event 2025-07-22
Patient Gender Female
Patient Age 64 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON APPROXIMATELY (B)(6) 2025, THE PATIENT WAS GETTING LOW CGM READINGS AROUND 07:00PM. WHEN THE PATIENT TOOK A FINGERSTICK THE CGM READING WAS 54 MG/DL, AND THE BLOOD GLUCOSE READING WAS 73 MG/DL. AN UNKNOWN TIME AFTER THIS, THE PATIENT BLACKED OUT AND FELL ON THE FLOOR. THE PATIENT DID NOT SUSTAIN ANY INJURIES, AND SELF-TREATED WITH A GLUCOSE TABLET AND SOME FOOD 15 MINUTES AFTER BLACKING OUT. NO FURTHER TREATMENT WAS REPORTED TO BE NEEDED, AND THE PATIENT DID NOT VISIT THE HOSPITAL. THE PATIENT COULD NOT REMEMBER IF THEY TOOK A FINGERSTICK AFTER THEY REGAINED CONSCIOUSNESS. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE A ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #171 - 3004753838-2025-256909 CRITICAL
View on MAUDE
Date of Event 2025-07-21
Patient Gender Male
Patient Age 15 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. ON (B)(6) 2025, THE BG WAS LOW (NO VALUE REPORTED) BUT THE CGM READING WAS SHOWING A NORMAL VALUE. THE PATIENT WAS UNCONSCIOUS AT THAT TIME AND HIS CO-WORKERS ASSISTED. WHEN THE PATIENT REGAINED CONSCIOUSNESS, HE SELF-TREATED WITH GLUCOSE TABLETS. AT THE TIME OF THE REPORT THE PATIENT WAS FINE. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #172 - 3004753838-2025-228742 CRITICAL
View on MAUDE
Date of Event 2025-07-21
Patient Gender Female
Patient Age 65 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. DATE OF EVENT IS AN APPROXIMATION. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT MENTIONED A COUPLE OF WEEKS AGO THAT SHE HAD A LOW READING AND PASSED OUT. HER SIBLING FOUND HER AND CALLED THE PARAMEDICS. THE PARAMEDICS CHECKED HER, AND GOT A METER READING OF 14 MG/DL. THE PATIENT SAID THE RECEIVER DIDN¿T ALERT HER, AND SHE COULDN¿T REMEMBER WHAT IT WAS SHOWING ON HER DEVICE AT THE TIME. PARAMEDICS GAVE HER A GLUCOSE INJECTION, AND SHE WAS FEELING BETTER AT THE TIME OF THE CALL. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #173 - 3004753838-2025-236010 CRITICAL
View on MAUDE
Date of Event 2025-07-20
Patient Gender Male
Patient Age 17 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT A SIGNAL LOSS OCCURRED. ON (B)(6) 2025, IT WAS REPORTED THAT AT AROUND 6:30-7PM EST, THE STARTED FEELING NAUSEATED AND LIGHT-HEADED. DEXCOM RECEIVER AND MOBILE WERE SHOWING SIGNAL LOSS AND IT HAD BEEN SHOWING THE ERROR SINCE 2PM WHEN THEY CHANGED THE SENSOR. THEY DID NOT DO A FINGERSTICK AT THE TIME BECAUSE THEY LEFT IT AT HOME. THE PATIENT USES INSULET OMNIPOD5 WHICH WOULD NOT HAVE BEEN IN MODIFIED CLOSED LOOP WITHOUT CGM. THE PARENT GAVE DIET PEPSI, GATORADE, AND WATER. THE PATIENT WAS VOMITING. THE DEXCOM WASN'T READING THE ENTIRE TIME BECAUSE OF SIGNAL LOSS. THE PATIENT WAS TAKEN TO THE EMERGENCY DEPARTMENT (ED), UNRESPONSIVE. THEY DID SOME TESTS, CHECKED HIS KETONES, AND SAID THAT HE WAS ON DKA WITH BLOOD GLUCOSE 898 MGDL. THEY GAVE HIM INSULIN THRU IV DRIP AND ZOFRAN FOR NAUSEA. AT AROUND 2AM ON (B)(6), HE WAS TRANSFERRED TO A DIFFERENT FACILITY. THE GLUCOSE GOT STABILIZED AT 120 MGDL AND HE GOT OUT OF THE HOSPITAL ON (B)(6) AND 6:24PM EST. THE PATIENT IS OKAY NOW. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #174 - 3004753838-2025-232976 CRITICAL
View on MAUDE
Date of Event 2025-07-15
Patient Gender Female
Patient Age 63 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN. ON (B)(6) 2025, THE PATIENT THAT THEY EXPERIENCED INACCURATE READINGS WITH THE CGM. THEY COULD NOT REMEMBER ANY VALUES FROM THE EVENT. THE PATIENT FAINTED AND HER DAUGHTER CALLED EMERGENCY MEDICAL SERVICES. PRIOR TO FAINTING, THE PATIENT DID NOT HAVE ANY SYMPTOMS. SHE WAS UNCONSCIOUS FOR 15-20 MINUTES. WHEN EMS ARRIVED, SHE WAS CONSCIOUS AND THEY TESTED HER BG AND IT WAS 25 MG/DL. THE CGM READING AT THE TIME WAS UNKNOWN. THE PATIENT WAS TREATED WITH IV GLUCOSE. ANOTHER BG WAS TAKEN BUT THE VALUE WAS NOT KNOWN. THE PATIENT TOLD EMS SHE DIDN'T NEED TO BE TAKEN TO THE HOSPITAL BECAUSE SHE FELT FINE. AT THE TIME OF THE REPORT, THE PATIENT WAS IN STABLE CONDITION. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR WITH 25 MG/DL BG METER READING. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #175 - 3004753838-2025-240396 CRITICAL
View on MAUDE
Date of Event 2025-07-13
Patient Gender Male
Patient Age 26 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON APPROXIMATELY (B)(6) 2025, THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM DUE TO A PAINFUL FOOT. UPON ARRIVAL TO THE ER, THE PATIENT WAS SWEATING AND ¿NEAR UNCONSCIOUSNESS¿. THE PATIENT¿S CGM WAS READING 77 MG/DL AND THE BG METER WAS READING 38 MG/DL. THE PATIENT WAS WEARING THE OMNIPOD DASH INSULIN PUMP (NON-INTEGRATED). THE PATIENT WAS TREATED WITH IV GLUCOSE. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY (SPECIFIC HOURS IN THE ER WAS NOT REPORTED) AND WAS ¿DOING FINE¿ AT THE TIME OF REPORT. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #176 - 3004753838-2025-245580 CRITICAL
View on MAUDE
Date of Event 2025-07-12
Patient Gender Male
Patient Age 55 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025 EVENT THE PATIENT EXPERIENCED WEAKNESS, COLLAPSED AND WAS UNCONSCIOUS. THE CGM READING WAS 88 MG/DL. NO FINGERSTICK WAS TAKEN BUT AN AMBULANCE WAS CALLED. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL, WHERE LAB TESTS REVEALED A CRITICALLY HIGH BLOOD GLUCOSE LEVEL OF 1078 MG/DL. THE PATIENT WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS AND WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT RECEIVED TREATMENT WITH INTRAVENOUS FLUIDS. THE PATIENT WAS DISCHARGED AFTER THREE DAYS. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4).
Report #177 - MW5176418 CRITICAL
View on MAUDE
Date of Event 2025-07-11
Patient Gender Female
Patient Age 24 YR
Device DEXCOM G7 (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
I HAVE BEEN USING THE DEXCOM G7 CONTINUOUS GLUCOSE MONITOR (CGM) FOR ABOUT A YEAR AFTER UPGRADING FROM THE G6 MODEL, AND IN THE PAST SEVERAL MONTHS, HAVE HAD EXTREME ISSUES WITH IT BEING INACCURATE AND THE INACCURACIES CAUSING ME HARM. MY INSULIN PUMP DELIVERY SYSTEM RELIES ON THE READINGS FROM THE CGM TO INFORM AUTOMATED DECISION-MAKING ON HOW MUCH INSULIN I RECEIVE AND, ON MANY INSTANCES, I HAVE RECEIVED TOO MUCH OR TOO LITTLE INSULIN BASED ON THE INACCURATE READINGS. AS PER MY DOCTOR, IF I HAVE A DISCREPANCY BETWEEN THE READING ON MY CGM AND A READING PROCURED MANUALLY FROM MY BLOOD GLUCOSE MONITOR, I AM TO TAKE THE MANUAL READING AS THE "CORRECT" VALUE. AS SUCH, THERE HAVE BEEN SEVERAL TIMES IN WHICH I PHYSICALLY FELT UNWELL IN A WAY THAT PROMPTED ME TO MANUALLY CHECK MY BLOOD SUGAR AS INSTRUCTED BY MY CARE TEAM AND FOUND THE READING TO BE INCREDIBLY OFF FROM THE CGM READING. ON THE MOST SEVERE OCCASION, (B)(6) 2025, MY CGM WAS DISPLAYING A VALUE WITHIN RANGE FOR SEVERAL HOURS, WHICH CAUSED MY INSULIN PUMP TO NOT GIVE ANY CORRECTIVE INSULIN TO REGULATE MY BLOOD SUGAR. I STARTED FEELING SYMPTOMS OF A HYPERGLYCEMIC EPISODE WHICH PROMPTED ME TO CHECK MY BLOOD SUGAR MANUALLY. THE MANUAL READING WAS 336, WHICH IS A LEVEL THAT IS INCREDIBLY HIGH AND DANGEROUS FOR MY HEALTH. HIGH BLOOD SUGAR CAN QUICKLY BECOME SEVERE AND CAUSE SERIOUS HEALTH PROBLEMS THAT REQUIRE EMERGENCY CARE, INCLUDING A DIABETIC COMA OR DEATH. HYPERGLYCEMIA, EVEN IF NOT SEVERE, CAN LEAD TO HEALTH PROBLEMS THAT CAN PERMANENTLY AFFECT THE EYES, KIDNEYS, NERVES, HEART, AND MORE. AS A RESULT OF THE CGM INACCURACIES, I HAD UNKNOWINGLY HAD HIGH BLOOD SUGAR FOR SEVERAL HOURS WITHOUT CORRECTION; I WAS LEFT FEELING SO UNWELL FROM THIS THAT I NEEDED TO LEAVE WORK. I AM ATTACHING PHOTOS BELOW OF THE INCIDENT, IN WHICH YOU CAN SEE THAT THE CGM READING AND THE GLUCOSE MONITOR READING ARE 3 MINUTES AND 237MG/DL APART. I HAVE ALSO HAD THE CONVERSE ISSUE SEVERAL TIMES, IN WHICH MY MONITOR READING WAS SIGNIFICANTLY LOWER THAN MY CGM READING, WHICH IS EQUALLY DANGEROUS AND TAKES FAR LESS TIME TO BECOME DEADLY. WHEN BLOOD SUGAR FALLS BELOW NORMAL LEVELS, IT MUST BE QUICKLY CORRECTED WITH FAST-ACTING CARBOHYDRATES. IF LEFT UNTREATED, HYPOGLYCEMIA CAN RAPIDLY BECOME DANGEROUS, WITH MILDER SYMPTOMS INCLUDING SHAKINESS, SWEATING, DIZZINESS, AND DISORIENTATION AND MORE SEVERE SYMPTOMS INCLUDING LOSS OF CONSCIOUSNESS, SEIZURES, AND DEATH. WHEN MY CGM WAS INDICATING A HIGHER-THAN-CORRECT BLOOD SUGAR LEVEL, NOT ONLY WAS I NOT ABLE TO PROPERLY TREAT THE HYPOGLYCEMIC EPISODE AS EARLY AS POSSIBLE WHICH LED TO WORSE SYMPTOMS, MY INSULIN PUMP WAS ALSO GIVING ME MORE INSULIN TO CORRECT THE "HIGH" BLOOD SUGAR READING IT GOT FROM MY CGM, ONLY EXACERBATING THE ISSUE. UNFORTUNATELY, THIS HAS NOT BEEN AN ISOLATED OR RARE ISSUE; IN THE PAST MONTHS, I HAVE EXPERIENCED COUNTLESS EXAMPLES OF THIS ERROR IN VARYING DEGREES OF SEVERITY IN BOTH DIRECTIONS. DESPITE REACHING OUT TO DEXCOM SUPPORT SEVERAL TIMES REGARDING THIS ISSUE, THE ONLY SOLUTION I HAVE BEEN OFFERED IS A REPLACEMENT SENSOR, WITH THE EXPLANATION THAT THE ONE I WAS USING MAY HAVE BEEN FAULTY. HOWEVER, THE REPLACEMENTS I RECEIVED WERE ALSO GIVING ME INCORRECT READINGS ON A REGULAR BASIS, THUS NOT SOLVING THE ISSUE.
Report #178 - 3004753838-2025-270901 CRITICAL
View on MAUDE
Date of Event 2025-07-05
Patient Gender Male
Patient Age 19 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SENSOR ERROR AFTER WHICH THEY EXPERIENCED A HYPOGLYCEMIC EVENT. AT AROUND 12:00 AM THE PATIENT WAS SLEEPING, WHEN THE PARENT, WHO IS ALSO A FOLLOWER WAS ALERTED ON THE FOLLOW APP THAT THAT THE PATIENT HAD NO READINGS. THE PARENT CHECKED ON THE PATIENT AND CONFIRMED THAT THE CGM APP WAS SHOWING "BRIEF SENSOR ISSUE". A FINGERSTICK WAS TAKEN AND THE BLOOD GLUCOSE READING WAS 70 MG/DL. NO ACTION WAS TAKEN AND THEY WENT BACK TO SLEEP. AT AROUND 3:00 AM, THE PARENT WAS ALERTED FOR THE SAME ERROR, AND WENT BACK TO CHECK ON THE PATIENT AGAIN, BUT THIS TIME, THE PATIENT WAS UNRESPONSIVE, THEIR EYES WERE DILATED, AND THEY WERE SWEATING. THE PARENT CALLED AN AMBULANCE AND WHEN THE PARAMEDICS TOOK A FINGERSTICK THE BLOOD GLUCOSE READING WAS 20 MG/DL. THE PARAMEDICS ADMINISTERED GLUCAGON THROUGH IV (MOST LIKELY PER INJECTION). NO FURTHER TREATMENT WAS REPORTED TO BE NEEDED AND THE PARAMEDICS STAYED UNTIL PATIENT BECAME STABLE. THE PARAMEDICS LEFT WHEN THE BLOOD GLUCOSE READING WAS 200 MG/DL. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS NOT CONFIRMED VIA DATA. HOWEVER, IT WAS FOUND THAT NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE UNDER AN HOUR OCCURRED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #179 - MW5175653 CRITICAL
View on MAUDE
Date of Event 2025-07-05
Patient Gender Male
Patient Age 25 YR
Device DEXCOM G7 (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
DEXCOM G7 HAD BEEN READING OFF FOR MONTHS. RANGING FROM 20 TO 100 IT'S OFF ON MY SON'S GLUCOSE. ON (B)(6) 2025, I WAS OUT OF TOWN AND HE DID NOT ANSWER THE PHONE SO I SENT FAMILY TO CHECK ON HIM. HE WAS UNRESPONSIVE WHEN POLICE AND PARAMEDICS ARRIVED HIS GLUCOSE WAS IN THE 20S. HOWEVER, HIS DEXCOM G7 WAS READING FROM ROUGHLY AROUND 80-90. HE CONSISTENTLY RECALIBRATES IT, SOMETIMES UP TO 4 OR 5 TIMES A DAY. THIS IS NOW BECOME MORE THAN A NUISANCE BUT A DANGEROUS SITUATION FOR HIM. DEXCOM JUST TELLS HIM TO RECALIBRATE IT. THE LAST FEW DAYS IT DID NOT WORK AT ALL. AFTER SEVERAL CALLS HE WAS TOLD THE APP WAS MESSED UP.
Report #180 - 3004753838-2025-275371 CRITICAL
View on MAUDE
Date of Event 2025-07-01
Patient Gender Male
Patient Age NA
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. THE DATE OF THE EVENT IS AN APPROXIMATION. ACCORDING TO AN INVESTIGATIVE REPORT VIA ONLINE PUBLISHED BY HUNTERBROOK MEDIA, A PATIENT EXPERIENCED STROKE-LIKE SYMPTOMS AROUND OR ON (B)(6) 2025 AND AN EVENT ALLEGEDLY LINKED TO A FAILURE OF AN UNSPECIFIED CONTINUOUS GLUCOSE MONITORING (CGM) DEVICE AND INSULIN PUMP USED IN A MODIFIED CLOSED-LOOP SYSTEM. THE REPORT, BASED ON A STATEMENT FROM THE PATIENT¿S SPOUSE, CLAIMS THAT THE DEVICE FAILED TO ALERT THE PATIENT TO DANGEROUSLY LOW BLOOD GLUCOSE LEVELS. AS A RESULT, THE PUMP CONTINUED TO DELIVER INSULIN WHEN IT WAS NOT NEEDED, LEADING TO THE PATIENT BECOMING COMATOSE. THE PATIENT¿S IDENTITY WAS NOT DISCLOSED IN THE ARTICLE, AND NO FOLLOW-UP INFORMATION WAS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Report #181 - 3004753838-2025-234121 CRITICAL
View on MAUDE
Date of Event 2025-07-01
Patient Gender Male
Patient Age 80 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. THE DATE OF THE EVENT IS AN APPROXIMATION. ON APPROXIMATELY (B)(6) /2025, THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT WHILE SLEEPING. HIS WIFE WAS UNABLE TO WAKE HIM AND REPORTED HIS CONDITION AS A ¿COMATOSE-LIKE STATE.¿ THE PATIENT REPORTED THAT HIS DEXCOM RECEIVER DID NOT ALERT HIM TO THE LOW GLUCOSE LEVEL. EMERGENCY MEDICAL SERVICES (EMS) WERE CONTACTED, AND THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM. HE RECALLED THAT HIS BLOOD GLUCOSE METER READING WAS APPROXIMATELY 32 MG/DL. THE PATIENT STATED HE WAS TREATED FOR HYPOGLYCEMIA; HOWEVER, NO SPECIFIC TREATMENT DETAILS WERE PROVIDED. HE WAS HOSPITALIZED OVERNIGHT AND DISCHARGED THE FOLLOWING DAY. ALTHOUGH THE REPORT STATES THE PATIENT WAS DISCHARGED THE NEXT/FOLLOWING DAY, THE LENGTH OF TIME IN THE HOSPITAL (LESS THAN OR MORE THAN 24 HOURS) IS UNKNOWN. THE PATIENT DECLINED TO SHARE ANY ADDITIONAL DETAILS REGARDING THE EVENT WITH DEXCOM. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION AND PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. | (B)(4).DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.
Report #182 - 3004753838-2025-243746 CRITICAL
View on MAUDE
Date of Event 2025-06-29
Patient Gender Female
Patient Age 36 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. THIS IS 1 OF 5 ALLEGATIONS OF INACCURACIES. THE PATIENT REPORTED 6 INSTANCES IN WHICH EACH EVENT HAS SIMILAR DETAILS BUT OCCURRED ON DIFFERENT EVENT DATES. PLEASE SEE RELATED RECORDS (B)(4). | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. THIS IS 1 OF 5 ALLEGATIONS OF INACCURACIES. THE PATIENT REPORTED 5 INSTANCES IN WHICH EACH EVENT HAS SIMILAR DETAILS BUT OCCURRED ON DIFFERENT EVENT DATES. ON (B)(6) 2025, THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS AND WAS DESCRIBED AS BEING ¿COMPLETELY BRUISED UP.¿ A NEIGHBOR CALLED EMERGENCY SERVICES, AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. UPON ARRIVAL, A FINGERSTICK BLOOD GLUCOSE READING WAS 46 MG/DL, WHILE THE CGM READING SHOWED 150 MG/DL, INDICATING A SIGNIFICANT DISCREPANCY. THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS, A ¿BIG DOSE OF GLUCOSE,¿ AND NAUSEA MEDICATION. BASED ON THE TREATMENT PROVIDED, THE EVENT WAS DETERMINED TO BE A HYPOGLYCEMIC EPISODE. THE PATIENT WAS DISCHARGED THE SAME DAY, AND NO FURTHER MEDICAL EVALUATION OR INTERVENTION WAS DOCUMENTED. AT THE TIME OF REPORTING, THE PATIENT WAS STABLE. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID WAS TAKEN IN THE ER. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #183 - 3004753838-2025-275294 CRITICAL
View on MAUDE
Date of Event 2025-06-27
Patient Gender Female
Patient Age 38 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. DATE OF EVENT IS AN APPROXIMATION. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED INACCURATE CGM VALUES READING 200 MG/DL, AND THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS. AN UNKNOWN TIME AFTER ON THE SAME DAY, THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS AND WAS FOUND BY THEIR MOTHER. NO FINGERSTICK WAS TAKEN AND AN AMBULANCE WAS CALLED. THE PATIENT WAS TREATED WITH INTRAVENOUS GLUCOSE AND WAS BROUGHT TO THE HOSPITAL. THE PATIENT COULD NOT REMEMBER HOW LONG SHE WAS UNCONSCIOUS FOR, AND WHAT THE CGM AND BLOOD GLUCOSE READINGS WERE AT THAT MOMENT. THE PATIENT WAS DISCHARGED THE DAY AFTER THE EVENT. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. NO OTHER DETAILS WERE DOCUMENTED. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #184 - 3004753838-2025-237529 CRITICAL
View on MAUDE
Date of Event 2025-06-22
Patient Gender Male
Patient Age 65 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ACCORDING TO THE PATIENT¿S SPOUSE, ON APPROXIMATELY 06/22/2025, WHILE AT CHURCH, THE PATIENT¿S SENSOR FAILED AND THE PATIENT¿S SPOUSE REMOVED IT. A NEW SENSOR WAS NOT PUT ON AT THIS TIME. SHORTLY AFTER SENSOR REMOVAL, THE PATIENT BECAME UNRESPONSIVE. THE PATIENT¿S SPOUSE CALLED EMERGENCY MEDICAL SERVICES (EMS) AND ATTEMPTED TO TREAT THE PATIENT WITH GLUCOSE TABLETS. HOWEVER, THE PATIENT HAD DIFFICULTY SWALLOWING AND WAS DROOLING. ONCE THE PATIENT WAS AT THE EMERGENCY ROOM (ER), THE PATIENT¿S BG METER READING WAS 44 MG/DL. THE PATIENT WAS TREATED WITH (2) GLUCAGON INJECTIONS AND (2) IV GLUCOSE DOSES. AFTER TREATMENT, THE PATIENT¿S BG LEVEL INCREASED TO 50 MG/DL BUT THE PATIENT WAS STILL UNSTABLE. THEREFORE, LATER THE SAME DAY, THE PATIENT WAS TRANSFERRED TO A SECOND MEDICAL FACILITY. AT THE SECOND FACILITY, THE PATIENT WAS GIVEN ANOTHER GLUCAGON INJECTION AND FURTHER UNSPECIFIED TREATMENT. AFTER SEVERAL HOURS, THE PATIENT REGAINED CONSCIOUSNESS. THE PATIENT WAS DISCHARGED ON 6/23/25. THE PATIENT WAS ¿FEELING FINE¿ AT THE TIME OF REPORT. PERFORMANCE DATA WAS REVIEWED. THE ALLEGATION WAS CONFIRMED DUE TO FINDINGS OF WEARABLE FAILURE. THE PROBABLE CAUSE WAS DETERMINED TO BE LOW COUNT ABERRATION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED.
Report #185 - 3004753838-2025-257604 CRITICAL
View on MAUDE
Date of Event 2025-06-17
Patient Gender Male
Patient Age 86 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4) DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA, SEIZURE AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE DATE OF THE EVENT IS AN APPROXIMATION. ON APPROXIMATELY (B)(6) 2025, THE PATIENT REPORTED THAT THEIR CGM SENSOR DISPLAYED A GLUCOSE VALUE OF 75 MG/DL, WHICH THEY CONSIDERED LOW. BASED ON THIS READING, THE PATIENT CONSUMED CARBOHYDRATES. NO SYMPTOMS WERE SPECIFIED AT THE TIME. FOLLOWING FOOD INTAKE, THE PATIENT NOTED THAT ¿THE CGM VALUES DID NOT MOVE UP THE WAY I WOULD HAVE EXPECTED.¿ NO ADDITIONAL CGM READINGS WERE PROVIDED. THE PATIENT THEN CHECKED THEIR BLOOD GLUCOSE USING A GLUCOMETER, WHICH SHOWED A VALUE OF 55 MG/DL. THE TIME INTERVAL BETWEEN THE CGM READING AND THE FINGERSTICK (FS) BGM VALUE WAS NOT DISCLOSED. A FEW MINUTES AFTER OBTAINING THE FS READING, THE PATIENT REPORTEDLY EXPERIENCED CONVULSIONS. EMERGENCY MEDICAL SERVICES (EMS) WERE CALLED BY THE PATIENT¿S SPOUSE. NO TREATMENT DETAILS OR BG VALUES OBTAINED BY PARAMEDICS WERE PROVIDED. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL, REMAINED OVERNIGHT, AND WAS DISCHARGED THE FOLLOWING DAY. ALTHOUGH THE REPORT STATES THE PATIENT WAS DISCHARGED THE NEXT/FOLLOWING DAY, THE LENGTH OF TIME IN THE HOSPITAL (LESS THAN OR MORE THAN 24 HOURS) IS UNKNOWN. NO FURTHER PATIENT, EVENT, OR TREATMENT DETAILS WERE AVAILABLE. DESPITE REQUESTS, NO ADDITIONAL INFORMATION COULD BE OBTAINED. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #186 - 3004753838-2025-234161 CRITICAL
View on MAUDE
Date of Event 2025-06-16
Patient Gender Female
Patient Age 25 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. | IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ACCORDING TO THE PATIENT, ON (B)(6) 2025, THE PATIENT WAS TAKEN TO THE HOSPITAL. THE PATIENT¿S FRIEND NOTICED THAT HER TANDEM MOBI WAS NOT COMMUNICATING WITH THE G7 SENSOR, AND IT SHOWED THE SENSOR FAILED. SHE WAS UNCONSCIOUS WHEN SHE WAS TAKEN TO THE HOSPITAL AND REGAINED CONSCIOUSNESS IN THE AMBULANCE. THE PATIENT AND HER FRIEND CANNOT RECALL HOW LONG SHE WAS OUT OF ACTIVE SENSOR SESSION WHEN HER FRIEND FOUND HER UNCONSCIOUS. SHE DID NOT DO ANY FINGER PRICK PRIOR AND AFTER THE FAILED SENSOR. THE PARAMEDICS TOOK A BG READING WHICH WAS ABOVE 20 MG/DL AND WHILE BEING TRANSPORTED TO ER, THE READING WAS 45 MG/DL. THE PATIENT WAS TREATED WITH INTRAVENOUS MEDICATION AND FOOD. THEY REMOVED THE INSULIN PUMP FROM HER BODY INCLUDING THE G7 SENSOR. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. AT THE TIME OF THE REPORT THE PATIENT WAS FINE. DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS CONFIRMED VIA DATA. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #187 - 3004753838-2025-237459 CRITICAL
View on MAUDE
Date of Event 2025-06-15
Patient Gender Male
Patient Age 59 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED ON (B)(6) 2025. ACCORDING TO THE PATIENT, ON APPROXIMATELY 06/15/2025, THE PATIENT EXPERIENCED INACCURATE VALUES ON THE CGM. ALTHOUGH NO SPECIFIC BG AND CGM VALUES WERE PROVIDED, THE CGM VALUE WAS HIGHER THAN THE BG, AND APPROXIMATELY 50-100 MG/DL DIFFERENT FROM THE BG VALUES. THE PATIENT HAD ATTEMPTED TO CALIBRATE THE SENSOR; HOWEVER, VALUES WERE STILL INACCURATE. AT THE TIME OF THE EVENT, HE LOST CONSCIOUSNESS AND FELL. HE ALSO HAD A SENSOR ERROR AND PAIN. THE PATIENT WAS BROUGHT TO AN URGENT CARE FACILITY FOR EVALUATION, AND A DIAGNOSTIC X-RAY WAS COMPLETED TO CHECK FOR AN ARM FRACTURE. THE ARM WAS NOT BROKEN HE ¿HAD A BONE BRUISE FROM THE ELBOW DOWN THE FOREARM.¿ THE PATIENT UTILIZED INSULIN PENS FOR DIABETES MANAGEMENT. ALTHOUGH CLARIFICATION AND ADDITIONAL EVENT DETAILS WERE REQUESTED, THE PATIENT DECLINED THE REQUEST TO PROVIDE ADDITIONAL INFORMATION ABOUT THE EVENT. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. IT HAS BEEN REPORTED THAT THERE WAS A DIFFERENCE IN READINGS O 50-100 POINTS. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #188 - 3004753838-2025-273582 CRITICAL
View on MAUDE
Date of Event 2025-06-11
Patient Gender Female
Patient Age 41 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON THE NIGHT OF JUNE 11TH (EXACT TIME NOT SPECIFIED), THE PATIENT¿S INSULIN PUMP WAS IN SLEEP MODE. AT THAT TIME, THE DEXCOM APP INDICATED THAT THE PATIENT¿S GLUCOSE LEVEL WAS HIGH; HOWEVER, THE PATIENT¿S ACTUAL BG WAS LOW. THERE IS NO DOCUMENTATION REGARDING WHEN THE BG MEASUREMENT WAS TAKEN OR WHO PERFORMED IT. THE PATIENT LOST CONSCIOUSNESS. HER HUSBAND RESUSCITATED HER AND CONTACTED EMERGENCY MEDICAL SERVICES (EMS). NO INFORMATION IS AVAILABLE REGARDING ANY MEDICATIONS ADMINISTERED DURING THE INCIDENT. AT THE TIME OF THE REPORT, THE PATIENT WAS DOING WELL. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #189 - 3004753838-2025-246392 CRITICAL
View on MAUDE
Date of Event 2025-06-01
Patient Gender Female
Patient Age 72 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT A TRANSMITTER BATTERY ISSUE OCCURRED. DATE OF EVENT IS AN APPROXIMATION. ON APPROXIMATELY (B)(6) 2025, PATIENT WAS NOT IN AN ACTIVE SENSOR SESSION AS THEY EXPERIENCED A ¿PAIR NEW TRANSMITTER¿ MESSAGE WHEN THEY TRIED TO CONNECT THEIR SENSOR. THE CURRENT TRANSMITTER THEY WERE USING, WAS BEING USED FOR AROUND 30 DAYS. AN UNKNOWN TIME AFTER THIS, THE PATIENT BEGAN FEELING NAUSEOUS AND PASSED OUT AT HOME. HER DAUGHTER FOUND HER UNRESPONSIVE AND CALLED 911. EMERGENCY SERVICES ARRIVED AND TRANSPORTED PATIENT TO THE HOSPITAL. IN THE EMERGENCY DEPARTMENT, PATIENT¿S BLOOD GLUCOSE WAS MEASURED AT 800 MG/DL. INSULIN ADMINISTERED (TYPE AND DOSE NOT DOCUMENTED AT THE TIME). THE PATIENT WAS ADMITTED AND RECEIVED ONGOING INSULIN THERAPY AND SUPPORTIVE CARE. THE PATIENT WAS DISCHARGED AFTER 5 DAYS AT THE HOSPITAL AND WHEN A FINGERSTICK WAS TAKEN THE BLOOD GLUCOSE READING WAS 125 MG/DL. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA.
Report #190 - 3004753838-2025-248859 CRITICAL
View on MAUDE
Date of Event 2025-05-30
Patient Gender Female
Patient Age 26 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. ON APPROXIMATELY (B)(6) 2025, THE PATIENT WAS ASLEEP UPSTAIRS WHILE HER HUSBAND WAS DOWNSTAIRS. AT AROUND 1:00 AM, THE HUSBAND HEARD THE PATIENT SCREAMING AND IMMEDIATELY WENT TO CHECK ON HER. THE PATIENT WAS UNABLE TO SPEAK AND APPEARED UNRESPONSIVE. THEY TOOK A BLOOD GLUCOSE LEVEL WHICH WAS 1.3 MMOL/L, WHICH WAS FLAGGED AS CRITICALLY LOW ON THE MONITORING APP. THE PATIENT DID NOT RECEIVE AN ALERT DESPITE HAVING LOW READING. EARLIER THAT AFTERNOON, PRIOR TO GOING TO BED, THE PATIENT'S GLUCOSE READING WAS 15 MMOL/L. PARAMEDICS ARRIVED AND APPLIED GLUCOSE GEL TO THE PATIENT'S GUMS DUE TO HER INABILITY TO SPEAK. AND ADMINISTERED A GLUCAGON INJECTION INTO THE PATIENT'S THIGH. THE PATIENT RECOVERED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #191 - 3004753838-2025-272190 CRITICAL
View on MAUDE
Date of Event 2025-05-28
Patient Gender Female
Patient Age NA
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM. IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED SINCE ON (B)(6) 2025 (REASON FOR HOSPITALIZATION WAS NOT REPORTED). ON APPROXIMATELY ON (B)(6) 2025, THE PATIENT REPORTEDLY WAS HYPOGLYCEMIC, HAD CONVULSION AND WAS IN A COMA. THE PATIENT WAS TREATED WITH IV GLUCOSE. IT COULD NOT BE DETERMINED WHEN THE VALUES WERE TAKEN (POST OR PRE-TREATMENT) THE CGM WAS READING 48 MG/DL AND THE BLOOD GLUCOSE READING WAS 70 MG/DL. AT THE TIME OF THE REPORT THE PATIENT WAS DOING GOOD. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.
Report #192 - 3004753838-2025-254002 CRITICAL
View on MAUDE
Date of Event 2025-05-25
Patient Gender Female
Patient Age 55 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT'S DEXCOM RECEIVER SHOWED LOW AFTER THE SENSOR WAS PUT ON THE ARM. NO MENTION IF THE PATIENT HAD SYMPTOMS. SHE DOESN'T HAVE A TESTER AND SHE JUST TOOK SUGAR TABLETS AND ATE; HOWEVER, THE CGM DID NOT CHANGE. SHE SAID HER SUGAR LEVEL WENT UP TO 2000 MG/DL. SHE WAS DIZZY, VOMITED AND PASSED OUT. AN AMBULANCE WAS CALLED AND SHE WAS REPORTEDLY COMATOSE IN DKA. THE PATIENT WAS INPATIENT FOR 8 DAYS AND TREATED WITH UNREMEMBERED IV BEFORE BEING RELEASED. NO OTHER DETAILS WERE DOCUMENTED. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS.
Report #193 - 3004753838-2025-255192 CRITICAL
View on MAUDE
Date of Event 2025-05-12
Patient Gender N/A
Patient Age N/A
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). | SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION WAS RECEIVED ON 09/15/2025. DATA WAS FURTHER REVIEWED. IT WAS INDICATED THAT THE PATIENT WAS USING AN UNSUPPORTED OPERATING SYSTEM, WHICH IS MISUSE OF THE DEVICE. DATA INVESTIGATION COULD NOT CONFIRM AN ALERT/NOTIFICATION SETTINGS ISSUE. CONFIRMATION OF THE COMPLAINT WAS UNDETERMINED VIA DATA. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). H6: MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. THE DATE OF THE EVENT IS AN APPROXIMATION. ON (B)(6) 2025, THE PATIENT REPORTED EXPERIENCING A LOW CONTINUOUS GLUCOSE MONITORING (CGM) VALUE IN THE LATE MORNING, APPROXIMATELY BETWEEN 11:00 A.M. AND NOON. NO SPECIFIC CGM VALUE WAS PROVIDED. THE PATIENT WAS SELF-TREATED BY EATING AND ADMINISTERING INSULIN, THEN PROCEEDED TO TAKE A NAP AROUND 1:00 P.M. THE PATIENT STATED THAT SHE RECEIVED HER FIRST LOW GLUCOSE ALERT AT 97 MG/DL; HOWEVER, SHE NOTED THAT THE ALERT WAS NOT AS LONG OR LOUD AS EXPECTED FROM THE MOBILE DEVICE. FOLLOWING THE ALERT, HER CGM VALUES REPORTEDLY DROPPED RAPIDLY, THOUGH NO SPECIFIC VALUES WERE DOCUMENTED. EVENTUALLY, THE PATIENT EXPERIENCED DISORIENTATION AND FELL TO THE FLOOR, RESULTING IN BRUISING ON HER LEG AND A BUMP ON HER HEAD. SHE REPORTED BEING UNCONSCIOUS FOR APPROXIMATELY TWO HOURS. THE PATIENT WAS AWAKENED BY HER DOG BARKING AND A NEIGHBOR KNOCKING AT HER DOOR. APPROXIMATELY 15 MINUTES AFTER REGAINING CONSCIOUSNESS, SHE SELF-TREATED WITH SODA FROM HER NIGHTSTAND. THE PATIENT DID NOT SEEK MEDICAL ATTENTION OR HIGHER-LEVEL CARE, AND THERE WAS NO DOCUMENTATION OF MEDICAL INTERVENTION. AT THE TIME OF THE REPORT, THE PATIENT WAS DESCRIBED AS ¿STABLE.¿ DATA HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #194 - 3004753838-2025-245118 CRITICAL
View on MAUDE
Date of Event 2025-05-01
Patient Gender Male
Patient Age 85 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). LABELING INDICATES: INSERTING THE SENSOR AND WEARING THE ADHESIVE PATCH MIGHT CAUSE INFECTION, BLEEDING, PAIN OR SKIN IRRITATIONS (E.G. REDNESS, SWELLING, BRUISING, ITCHING, SCARRING OR SKIN DISCOLORATION). | IT WAS REPORTED THAT A SKIN REACTION ISSUE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. PRIOR TO SENSOR INSERTION THE AREA WAS PREPPED WITH ALCOHOL. ON APPROXIMATELY (B)(6) 2025, THE PATIENT DEVELOPED A RASH AND REDNESS AT THE INSERTION SITE AND OVER TIME, THE RASH SPREAD ACROSS HIS BODY. THE SPOUSE STATED IT WAS AN ALLERGIC REACTION TO THE ADHESIVE OR MATERIAL IN THE SENSOR. ON AN UNSPECIFIED DATE, THE PATIENT CONSULTED A DERMATOLOGIST, WHO PRESCRIBED CAVILON CREAM TO HELP MINIMIZE THE REACTION. THE REPORTER DID NOT MENTION HOW LONG HE USED THE CREAM OR WHETHER HE IS STILL USING IT. THE SPOUSE DID NOT REPORT ANY OTHER HEALTH CONDITIONS OR SERIOUS MEDICAL ISSUES, AND THE SENSOR CONTINUED TO PROVIDE ACCURATE READINGS THROUGHOUT THE REACTION. THE SPOUSE CONFIRMED THAT THE REACTION WAS LIMITED TO THE SKIN, AND HE DID NOT EXPERIENCE LIFE THREATENING SYMPTOMS. AT THE TIME OF THE REPORT, THE PATIENT WAS DOING WELL. NO DATA OR PRODUCT WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Report #195 - 3004753838-2025-271383 CRITICAL
View on MAUDE
Date of Event 2025-04-09
Patient Gender Male
Patient Age 68 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. ON 04/09/2025, THE PATIENT RECEIVED AN ALERT FROM THEIR RECEIVER INDICATING THAT THE SENSOR HAD FAILED. THIS CAUSED SIGNIFICANT DISTRESS. THE LAST KNOWN ESTIMATED GLUCOSE VALUE (EGV) PRIOR TO THE FAILURE WAS NOT DOCUMENTED. AT THE TIME OF THE ALERT, THE PATIENT HAD NO MEANS TO CHECK OR TRACK THEIR GLYCEMIC STATUS, AS THEY DID NOT HAVE ACCESS TO FINGERSTICK (FS) TESTING SUPPLIES. THE PATIENT REPORTED FEELING WEAK AND SUBSEQUENTLY DIALED 911. UPON EMS ARRIVAL, THE PATIENT WAS FOUND UNCONSCIOUS, HAVING COLLAPSED. HE REGAINED CONSCIOUSNESS IN THE EMERGENCY DEPARTMENT (ED), WHERE HIS BLOOD GLUCOSE (BG) WAS MEASURED AT 400 MG/DL. DESPITE REGAINING CONSCIOUSNESS, THE PATIENT CONTINUED TO FEEL UNWELL, EXPERIENCING MOBILITY ISSUES AND DIFFICULTY SPEAKING. HE WAS ADMINISTERED INTRAVENOUS (IV) FLUIDS. AN MRI WAS PERFORMED, WHICH REVEALED EVIDENCE OF A STROKE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND REMAINED INPATIENT FOR THREE DAYS. AT THE TIME OF THE REPORT, THE PATIENT WAS OKAY BUT SLIGHTLY TIRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Report #196 - 3004753838-2025-235570 CRITICAL
View on MAUDE
Date of Event 2025-04-04
Patient Gender Male
Patient Age 54 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. ON (B)(6) 2025, AROUND 9AM, THE PATIENT WAS DRIVING TO WORK AND PASSED OUT WHILE DRIVING. THE PATIENT REPORTED NEVER RECEIVING AN ALERT FROM HIS MOBILE APP TO NOTIFY HIM OF HIS HYPOGLYCEMIC STATE, NOR DID HE FEEL ANY SYMPTOMS PRIOR TO LOSING CONSCIOUSNESS. WHEN THE PATIENT WOKE UP, HE WAS BEING TREATED WITH IV GLUCOSE BY EMERGENCY MEDICAL SERVICES. HIS CGM VALUE NOR HIS BG METER READING WERE NOT REPORTED AT THIS TIME. WHILE THE PATIENT WAS IN TRANSPORT TO THE EMERGENCY ROOM (AFTER TREATMENT WITH IV GLUCOSE) THE PATIENT¿S BG METER READING WAS 200 MG/DL. THE PATIENT¿S WRIST WAS ALSO HURTING BECAUSE OF THE ACCIDENT. AT THE ER, THE PATIENT COULD NOT RECALL HIS CGM OR BG METER VALUES. HOWEVER, HE WAS TOLD HIS BG LEVEL WAS ¿NORMAL¿, THEREFORE, NO FURTHER MEDICATION WAS PROVIDED TO THE PATIENT. THE PATIENT ALSO UNDERWENT AN EKG (ELECTROCARDIOGRAM). THE PATIENT WAS DISCHARGED FROM THE ER AFTER APPROXIMATELY 2 HOURS. THE PATIENT CONTINUED TO WEAR THE SAME SENSOR FOR THE FULL 10-DAY SESSION. THE PATIENT WAS ¿OKAY¿ AT THE TIME OF REPORT. DATA HAS BEEN REQUESTED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #197 - 3004753838-2025-243333 CRITICAL
View on MAUDE
Date of Event 2025-04-01
Patient Gender Female
Patient Age 72 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. THE DATE OF THE EVENT IS AN APPROXIMATION. ON (B)(6) 2025, THE PATIENT REPORTED DIFFICULTY RETAINING FOOD AND CONTACTED HER PHYSICIAN. ONDANSETRON WAS PRESCRIBED; HOWEVER, THE PATIENT STATED THAT THE INTERVENTION CAME ¿TOO LATE.¿ AT AN UNSPECIFIED TIME ON FRIDAY, THE PATIENT LOST CONSCIOUSNESS. THERE IS NO DOCUMENTATION REGARDING THE CGM (CONTINUOUS GLUCOSE MONITOR) READINGS PRIOR TO THE LOSS OF CONSCIOUSNESS. THE PATIENT WAS NOT DISCOVERED UNTIL MONDAY, WHEN HER SISTER FOUND HER AND TRANSPORTED HER TO THE EMERGENCY ROOM. AT THAT TIME, THE PATIENT WAS DIAGNOSED AS BEING IN A ¿DIABETIC COMA.¿ NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE PATIENT¿S HOSPITALIZATION, TREATMENT, OR RECOVERY. IT IS ALSO UNKNOWN WHEN THE PATIENT REGAINED CONSCIOUSNESS. THE PATIENT LATER RECALLED THAT HER SON INFORMED HER SHE HAD BEEN HOSPITALIZED FOR THREE DAYS. AT THE TIME OF THE REPORT, THE PATIENT¿S CGM READING WAS 302 MG/DL, ALTHOUGH SHE NOTED THAT IT HAD BEEN 104 MG/DL AT LUNCHTIME. DATA HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #198 - 3004753838-2025-239055 CRITICAL
View on MAUDE
Date of Event 2025-03-29
Patient Gender Female
Patient Age 70 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. THE DATE OF THE EVENT IS AN APPROXIMATION. ON (B)(6) 2025, THE PATIENT CONTACTED SUPPORT FOR ASSISTANCE SETTING AN ALARM ON THE G7 DEVICE. DURING THE CONVERSATION, THE PATIENT VOLUNTARILY SHARED A PRIOR INCIDENT THAT OCCURRED ON (B)(6) 2025 WHILE USING THE G6 SYSTEM. THE PATIENT REPORTED FEELING EXTREMELY HOT AND DIZZY BEFORE LOSING CONSCIOUSNESS. SHE WAS UNABLE TO RECALL SPECIFIC CONTINUOUS GLUCOSE MONITOR (CGM) READINGS OR OTHER DETAILS RELATED TO THE EVENT. AT THE TIME OF THE REPORT, THE PATIENT HAD RECOVERED AND WAS STABLE. NO ADDITIONAL INFORMATION REGARDING MEDICAL INTERVENTION OR OUTCOMES WAS PROVIDED. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. PROBLEM COULD NOT BE CONFIRMED AND PROBABLE CAUSE CANNOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. | (B)(4). H6: MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #199 - 3004753838-2025-265403 CRITICAL
View on MAUDE
Date of Event 2025-03-01
Patient Gender Male
Patient Age 75 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ACCORDING TO THE PATIENT¿S SPOUSE, ON APPROXIMATELY (B)(6) 2025, THE PATIENT GOT AN INACCURATE READING, THE CGM WAS REALLY LOW. THE REPORTER IS UNABLE TO RECALL THE CGM OR BG VALUE. THE PATIENT SUDDENLY PASSED OUT AND WAS UNCONSCIOUS. WITHOUT GIVING ANY MEDICATION, THEY CALLED 911. THE PARAMEDICS ARRIVED AND TREATED THE PATIENT WITH INTRAVENOUS (IV) GLUCOSE. WHEN THE PATIENT WOKE UP, HE WAS UNABLE TO RECOGNIZE ANYONE, EVEN HIS SPOUSE, SO THEY SENT THE PATIENT TO THE HOSPITAL TO GET FURTHER MEDICAL TREATMENT. AT THE HOSPITAL, THEY CHECKED HIS BG READING, THE SPOUSE IS UNABLE TO RECALL THE VALUE. THE PATIENT WAS TREATED WITH ORAL AND IV MEDICATION FOR DIABETES, BLOOD PRESSURE, AND FOR HIS CANCER. THE PATIENT STAYED AT THE HOSPITAL FOR 3 DAYS AND WHEN THE DOCTORS MADE SURE HE WAS OKAY, HE WAS SENT HOME. THERE WERE NO CGM AND BG VALUES AND SPECIFIC MEDICATION PROVIDED DURING THE CALL AS THE SPOUSE AND THE PATIENT SAID THAT THEY NO LONGER RECALL THE INFORMATION. AT THE TIME OF THE REPORT THE PATIENT WAS OK. NO OTHER DETAILS WERE DOCUMENTED. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #200 - 3004753838-2025-255774 CRITICAL
View on MAUDE
Date of Event 2025-03-01
Patient Gender Male
Patient Age 46 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE EVENT DATE IS AN APPROXIMATION. ACCORDING TO A REPORT RECEIVED BY CANADA CONSULTANT THAT ON APPROXIMATELY ON (B)(6) 2025, THE PATIENT¿S DEXCOM DEVICE WAS DISPLAYING A ¿HIGH¿ GLUCOSE READING, ALTHOUGH THE PATIENT WAS ASYMPTOMATIC AT THE TIME. AT SOME POINT, THE PATIENT LOST CONSCIOUSNESS. AN UNIDENTIFIED INDIVIDUAL PROVIDED JUICE AND TRANSPORTED THE PATIENT TO THE HOSPITAL. UPON ARRIVAL, THE PATIENT REGAINED CONSCIOUSNESS. A PHYSICIAN EVALUATED THE PATIENT IN THE VEHICLE, CHECKED VITAL SIGNS, AND PERFORMED A BLOOD GLUCOSE TEST (NO VALUE DOCUMENTED). THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL AND WAS DISCHARGED SHORTLY THEREAFTER. NO FURTHER TREATMENT WAS DOCUMENTED, AND THE PATIENT WAS UNABLE TO RECALL ADDITIONAL DETAILS. AT THE TIME OF REPORTING, THE PATIENT WAS FEELING FINE. ALTHOUGH ADDITIONAL ATTEMPTS WERE MADE TO OBTAIN CLARIFICATION OF EVENT DETAILS, NO REPLY HAS BEEN RECEIVED. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #201 - 3004753838-2025-273276 CRITICAL
View on MAUDE
Date of Event 2025-02-07
Patient Gender Female
Patient Age 65 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. H6: HEALTH EFFECT - IMPACT CODE - 4623 - REHABILITATION. | IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. ACCORDING TO THE PATIENT, ON (B)(6) 2025, IT WAS AROUND 24 HOURS FROM THE SENSOR FAILURE BEFORE THE EVENT HAPPENED. THE PATIENT CALLED HER BROTHER; HE AND HIS AND HIS WIFE ARRIVED 3 HOURS LATER BECAUSE THEY LIVE FAR FROM THE PATIENT. WHEN THEY ARRIVED, THEY FOUND THE PATIENT IN THE BATHTUB UNCONSCIOUS AND CALLED 911. PARAMEDICS ARRIVED AND THEY TOOK HER TO THE HOSPITAL. THE PATIENT IS UNABLE TO RECALL DETAILS OF THE EVENT, BUT SHE SAID HER BLOOD GLUCOSE READING AT THE HOSPITAL WAS APPROXIMATELY 900 MG/DL. THE PATIENT WAS ALSO DIAGNOSED WITH FLU AND PNEUMONIA APART FROM HYPERGLYCEMIA. THE PATIENT STAYED AT THE ICU FOR 2 WEEKS FOLLOWED BY REHAB FOR THERAPY BECAUSE SHE WAS UNABLE TO WALK. THE PATIENT WAS RELEASED FROM REHAB APPROXIMATELY THE LAST WEEK OF APRIL. THE PATIENT IS UNSURE WHY SHE WAS NOT ABLE TO WALK OR WHAT MEDICATION SHE WAS GIVEN. AT THE TIME OF THE REPORT THE PATIENT FELT OKAY. NO DATA OR PRODUCT WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #202 - 3004753838-2025-267310 CRITICAL
View on MAUDE
Date of Event 2025-02-07
Patient Gender Female
Patient Age 65 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. ON (B)(6) 2025, THE PATIENT STATED THAT THE CGM FAILED TO FUNCTION PROPERLY. THE PATIENT'S BLOOD SUGAR REPORTEDLY SPIKED HIGH TO 1000 MG/DL. THE PATIENT HAD PNEUMONIA AND THE FLU DURING THIS TIME. THE PATIENT PASSED OUT IN HE BATHTUB AND WAS FOUND BY THEIR BROTHER. THE BROTHER TRIED TO HELP THE PATIENT FOR 2 HOURS PRIOR TO CALLING 911. WHEN PARAMEDICS ARRIVED, THEY TRANSPORTED THE PATIENT TO THE TRAUMA CENTER WHERE THEY WERE REPORTEDLY IN CARDIAC ARREST. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THERE WAS NO INFORMATION ABOUT TREATMENT WHILE IN THE ICU. THE PATIENT WAS IN THE ICU FOR 2 WEEKS. AFTER THIS THEY WERE TRANSFERRED TO A REGULAR UNIT FOR 1 WEEK AND THEN TO A REHABILITATION CENTER. AT THE REHABILITATION CENTER, THE PATIENT HAD PHYSICAL THERAPY. AT THE TIME OF THE REPORT, THE PATIENT WAS FEELING BETTER. NO DATA OR PRODUCT WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. H6 HEALTH EFFECT - IMPACT CODE F18 REHABILITATION. H6 HEALTH EFFECT - IMPACT CODE F14 PROLONGED EPISODE OF CARE.
Report #203 - 3004753838-2025-245557 CRITICAL
View on MAUDE
Date of Event 2025-01-31
Patient Gender Male
Patient Age 53 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA, DIABETIC KETOACIDOSIS AND LOSS OF CONSCIOUSNESS | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. ON 01/31/2025, THE PATIENT EXPERIENCED SIGNIFICANT PHYSICAL DISTRESS, INCLUDING DIFFICULTY STANDING AND WALKING, DISORIENTATION, DIZZINESS, AND ELEVATED BLOOD PRESSURE. THE PATIENT LOST CONSCIOUSNESS, AS IT WAS REPORTED THAT HE ¿WOKE UP¿ IN THE HOSPITAL. UPON ARRIVAL AT THE HOSPITAL, A FINGERSTICK BLOOD GLUCOSE READING WAS TAKEN, SHOWING A LEVEL CLOSE TO 500 MG/DL. THE PATIENT¿S CGM RECEIVER WAS NOT BROUGHT TO THE HOSPITAL, SO CGM DATA COULD NOT BE VERIFIED. HOWEVER, PRIOR TO THE EVENT, CGM READINGS WERE REPORTEDLY BETWEEN 140¿160 MG/DL. THE PATIENT WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA) AND ADMITTED TO THE INTENSIVE CARE UNIT (ICU). TREATMENT INCLUDED INTRAVENOUS INSULIN AND FLUIDS. THE PATIENT WAS DISCHARGED AFTER A THREE-DAY HOSPITAL STAY. THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR FOLLOW-UP INTERVENTION. WHEN ASKED ABOUT HIS CURRENT CONDITION, THE PATIENT STATED, ¿I'M HAVING KIDNEY ISSUES,¿ THOUGH IT IS UNCLEAR WHETHER THIS IS RELATED TO THE DKA EPISODE. IT WAS UNDERSTOOD THAT THE PATIENT RECOVERED FROM THE DKA. NO ADDITIONAL DETAILS WERE DOCUMENTED. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #204 - 3004753838-2025-274595 CRITICAL
View on MAUDE
Date of Event 2024-12-17
Patient Gender Female
Patient Age 67 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. | IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. ON (B)(6) 2024, THE PATIENT WAS UNAWARE HOW THE DEXCOM DEVICE WAS FUNCTIONING AT THE TIME OF THE EVENT BUT STATED THAT A POSSIBLE MALFUNCTION COULD HAVE BEEN THE REASON WHY SHE HAD TO GO TO THE HOSPITAL. IT WAS REPORTED THAT IT COULD BE THAT THE CGM DEVICE DID NOT ALERT HER, BUT THE PATIENT WAS UNSURE. THE PATIENT STATED THAT SHE HAD BEEN EXPERIENCING ISSUES WITH THE RECEIVER ALERTS, AND THAT MOST OF THE TIME THE RECEIVER WOULD NOT ALERT HER WHEN IT WAS SUPPOSED TO. HOWEVER, NO SPECIFIC MALFUNCTION WAS REPORTED FOR THIS EVENT. ON THE DAY OF THE EVENT THE PATIENT WENT INTO A ¿COMA¿ DUE TO DIABETIC KETOACIDOSIS. WHEN THE PATIENT REGAINED CONSCIOUSNESS SHE WAS AT THE HOSPITAL AND THE BLOOD GLUCOSE READING WAS OVER 1200 MG/DL. THE PATIENT WAS NOT WEARING A DEXCOM SENSOR ANYMORE WHEN SHE REGAINED CONSCIOUSNESS. THE PATIENT DID NOT REMEMBER ANY FURTHER DETAILS REGARDING THE EVENT. AT THE TIME OF THE REPORT THE PATIENT WAS STILL NOT FEELING OKAY, AND EXPERIENCED SHAKING. HOWEVER, IT WAS UNDERSTOOD THAT THE PATIENT RECOVERED FROM THE DIABETIC KETOACIDOSIS. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION AND PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.
Report #205 - 3004753838-2025-240971 CRITICAL
View on MAUDE
Date of Event 2024-12-04
Patient Gender Male
Patient Age 83 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED BECAUSE OF INACCURATE READINGS. THE CGM WAS AT 197 MG/DL AND RISING SO HE TOOK 6 UNITS OF INSULIN (NOVOLOG), WENT TO BED AT MIDNIGHT. PT DIDN¿T DO A FINGER PRICK. AROUND 4AM, HE WAS SWEATING AND PASSED OUT. HIS WIFE FOUND HIM AND CALLED 911. PATIENT DOESN¿T KNOW WHAT HIS BG AND CGM READINGS WERE ONSET OF HIS SYMPTOMS. AN AMBULANCE CAME, TOOK A FINGER STICK AND HIS BG READING WAS 42 MG/DL. HE DOESN'T KNOW WHAT HIS CGM READING WAS WHEN THE AMBULANCE ARRIVED BECAUSE HE ALREADY PASSED OUT. WHILE IN THE AMBULANCE, THEY TREATED THE PATIENT WITH GLUCOSE IV DRIP. HE WAS ON THE DRIP FROM 4AM TO 3PM. THE PATIENT WAS DIAGNOSED WITH HYPOGLYCEMIA AND MIGHT HAVE A HEART ENZYME PROBLEM SO THEY HAD A CARDIOLOGIST CHECKED HIM AND SAID HE WAS FINE THAT IT DIDN'T AFFECT HIS HEART. HE STAYED AT THE HOSPITAL FOR 6 DAYS. HE WAS DISCHARGED ON (B)(6) 2024 (TUESDAY) AT 4:45PM. AT THE TIME OF THE REPORT HE WAS PERFECTLY FINE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #206 - 3004753838-2025-240916 CRITICAL
View on MAUDE
Date of Event 2024-11-24
Patient Gender Male
Patient Age 77 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. ON APPROXIMATELY (B)(6) 2025, THE PATIENT PASSED OUT DUE TO HYPOGLYCEMIA WHEN THE CGM WAS READING LOW BUT THE RECEIVER DID NOT PROVIDE AN ALERT SOUND. THE PATIENT COULD NOT RECALL THE VALUE ON THE CGM AND DID NOT CHECK A MANUAL BLOOD GLUCOSE FINGER STICK. THE PATIENT'S SON CALLED AN AMBULANCE BUT CANCELLED THE CALL BECAUSE THE PATIENT HAD RECOVERED AFTER THE SON PROVIDED HIM SODA. AS A RESULT OF PASSING OUT, THE PATIENT STATED HE BROKE THE BRIDGE ON HIS TEETH. AT THE TIME OF THE REPORT, THE PATIENT WAS DOING OKAY. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION AND PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.
Report #207 - 3004753838-2025-239064 CRITICAL
View on MAUDE
Date of Event 2024-10-17
Patient Gender Female
Patient Age 70 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. THE DATE OF THE EVENT IS AN APPROXIMATION. ON (B)(6) 2024, THE PATIENT WAS FOUND UNCONSCIOUS AND LYING ON THE FLOOR BY HER GRANDDAUGHTER, WHO IMMEDIATELY CALLED 911. THE PATIENT RECALLED HAVING DINNER THE NIGHT BEFORE AND GOING TO BED BUT HAD NO MEMORY OF THE INCIDENT UNTIL SHE WOKE UP IN THE HOSPITAL THE FOLLOWING DAY. THERE WAS NO DOCUMENTATION FOR CONTINUOUS GLUCOSE MONITOR (CGM) READINGS DURING THE EVENT. EMERGENCY MEDICAL SERVICES (EMS) INFORMED THE PATIENT THAT HER BLOOD GLUCOSE LEVEL WAS ¿VERY LOW,¿ AND SHE WAS TREATED WITH INTRAVENOUS GLUCOSE (¿IV SUGAR¿). THE PATIENT WAS HOSPITALIZED FOR APPROXIMATELY 2¿3 DAYS BEFORE BEING DISCHARGED. AT THE TIME OF THE REPORT, THE PATIENT WAS STABLE AND STATED SHE WAS ¿OKAY.¿ NO ADDITIONAL DETAILS WERE AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. PROBLEM COULD NOT BE CONFIRMED AND PROBABLE CAUSE CANNOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. | (B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #208 - 3004753838-2025-249711 CRITICAL
View on MAUDE
Date of Event 2024-08-25
Patient Gender Female
Patient Age 81 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. ON (B)(6) 2025, THE PATIENT LOST CONSCIOUSNESS WHILE DRIVING THE CAR. THE LAST CGM READING THE PATIENT REMEMBER WAS 55 MG/DL. ACCORDING TO THE PATIENT THE ALERT WOULD HAVE BEEN DELAYED BY 5 MINUTES. AN AMBULANCE WAS CALLED BY A LADY THAT WAS PASSING BY. THE PATIENT REGAINED CONSCIOUSNESS IN THE AMBULANCE. THE PATIENT DID NOT REMEMBER IF, AND WHAT TYPE OF TREATMENT, WAS GIVEN. THE PATIENT RECOVERED AND WAS NOT BROUGHT TO THE HOSPITAL. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #209 - 3004753838-2025-240894 CRITICAL
View on MAUDE
Date of Event 2024-03-31
Patient Gender Male
Patient Age 75 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT WAS AWAKENED BY HIS SPOUSE DUE TO A CGM ALERT INDICATING A LOW GLUCOSE READING OF 45 MG/DL. THE PATIENT WAS SWEATING, BUT A CONFIRMATORY FINGERSTICK SHOWED A READING OF APPROXIMATELY 80 MG/DL. NO CALIBRATION WAS PERFORMED. THE PATIENT CONSUMED ORANGE JUICE, AND THE CGM READINGS BEGAN TO RISE. HE THEN RETURNED TO SLEEP. BETWEEN 2:00¿3:00 AM, ANOTHER LOW GLUCOSE ALERT OCCURRED, SHOWING A CGM READING OF 51 MG/DL. NO FINGERSTICK WAS TAKEN AT THIS TIME, AS THE PATIENT HAD LOST CONSCIOUSNESS. EMERGENCY SERVICES (911) WERE CALLED, AND PARAMEDICS ARRIVED WITHIN FIVE MINUTES. THE PATIENT RECEIVED AN INTRAVENOUS GLUCOSE INJECTION. APPROXIMATELY 30 MINUTES LATER, THE PATIENT REGAINED CONSCIOUSNESS. THE CGM READING HAD RISEN TO 200 MG/DL. A FINGERSTICK WAS PERFORMED, BUT THE PATIENT COULD NOT RECALL THE EXACT VALUE, THOUGH IT WAS REPORTEDLY SIMILAR. THE PARAMEDICS DID NOT TRANSPORT THE PATIENT TO THE HOSPITAL, AS HIS CONDITION HAD STABILIZED. NO CALIBRATION WAS PERFORMED THROUGHOUT THE INCIDENT. AT THE TIME OF THE REPORT THE PATIENT WAS FEELING GOOD. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #210 - 3004753838-2025-275124 CRITICAL
View on MAUDE
Date of Event 2024-03-01
Patient Gender Male
Patient Age 83 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2024, WHICH IS OFF-LABEL USAGE OF THE DEVICE. DATE OF EVENT IS AN APPROXIMATION. ON THE SAME DAY, IT WAS REPORTED THAT THE PATIENT WAS RUSHED TO THE HOSPITAL AFTER GETTING LOW READING ON THE MOBILE DEVICE. THE ALLEGATION AGAINST THE DEVICE WAS NOT SPECIFIED IN THIS DOCUMENTATION. AROUND 03/01/2024, THE PATIENT INSERTED A NEW G7 SENSOR. UPON COMPLETING THE WARMUP, THE G7 MOBILE APP GAVE HIM AN ALERT AT AROUND 3:00 PM, SAYING THAT HE HAD A CGM OF ABOUT 40 MGDL. HE DID NOT TAKE A FINGERSTICK READING OR DID ANY CALIBRATIONS. HE THEN WENT TO THE KITCHEN TO GET SOME GLUCOSE TABLETS HOWEVER ON THE WAY, HE VOMITED AND PASSED OUT. HIS WIFE FOUND HIM UNCONSCIOUS AND IMMEDIATELY CALLED 911. WHEN THE PARAMEDICS ARRIVED, THEY DID A FINGERSTICK WHICH SHOWED THAT HE HAD A BG READING OF ABOUT 40 MGDL. HE COULD NOT RECALL WHAT WAS THE CGM READING AT THAT TIME OF THE FINGER STICK READING. THE PATIENT COULD NOT RECALL HOW LONG HE WAS UNCONSCIOUS. BUT WHEN HE DID GAIN CONSCIOUSNESS, THE PARAMEDICS GAVE HIM IV GLUCOSE AND SWEETS TO BRING UP HIS GLUCOSE. THE PATIENT WAS THEN BROUGHT BY THE PARAMEDICS TO THE HOSPITAL BY THE PARAMEDICS (CANNOT RECALL THE TIME OF ARRIVAL). THE HOSPITAL STAFF THEN TOOK A FINGER STICK AND IT SHOWED THAT HE HAD A LOW READING (CANNOT RECALL THE VALUE). HE COULD NOT REMEMBER WHAT HIS CGM READING WAS WHEN HE ARRIVED AT THE HOSPITAL. HE COULD NOT ALSO RECALL WHAT MEDICATIONS/TREATMENTS WERE GIVEN AT THE HOSPITAL. HE HAD TO BE CONFINED BECAUSE HE HAD ASPIRATION PNEUMONIA DUE TO SOME OF THE VOMIT GOING INTO HIS LUNGS. HE COULD NOT RECALL HOW LONG HE STAYED AT THE HOSPITAL BUT HE STAYED THERE FOR MORE THAN 24 HOURS. HE IS FEELING FINE AFTER HIS DISCHARGE AND DURING THE CALL. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #211 - 3004753838-2025-236835 CRITICAL
View on MAUDE
Date of Event 2024-02-01
Patient Gender Male
Patient Age 74 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. | IT WAS REPORTED THAT ALERT/NOTIFICATION SETTINGS OCCURRED. THE DATE OF THE EVENT IS AN APPROXIMATION. IN (B)(6) 2024, THE PATIENT WAS TAKEN TO THE HOSPITAL BY PARAMEDICS DUE TO HYPOGLYCEMIA. THE PATIENT REPORTED THAT HE DID NOT HEAR THE ALARM FROM HIS TANDEM PUMP, STATING IT WAS NOT LOUD ENOUGH, ESPECIALLY COMPARED TO THE PHONE ALARM. HE CONFIRMED THAT THIS WAS THE REASON FOR THE HOSPITAL VISIT. AT THE TIME, HE WAS WORKING AND HAD GONE TO THE RESTROOM, WHERE HE MISSED THE ALARM. HE EXPERIENCED COLD SWEATS, FOLLOWED BY LOSS OF CONSCIOUSNESS, DURING WHICH HE HIT HIS HEAD. HIS DAUGHTER CALLED 911, AND PARAMEDICS TRANSPORTED HIM TO THE HOSPITAL. THE PATIENT STATED THAT THE CGM READINGS WERE LOW AND REITERATED THAT THE ISSUE WAS NOT WITH THE ACCURACY OF THE READINGS, BUT WITH THE VOLUME OF THE PUMP AND PHONE ALARMS, WHICH HE DID NOT HEAR. HE WAS HOSPITALIZED FOR 3-4 DAYS. DURING HIS STAY, THE CGM SENSOR WAS REMOVED, AND BG LEVELS WERE MONITORED MANUALLY. THE PATIENT RECALLED THAT BG VALUES RANGED FROM 429 MG/DL TO VERY HIGH LEVELS, THOUGH HE COULD NOT PROVIDE SPECIFIC READINGS OR RECALL THE MEDICATION ADMINISTERED DURING THE VISIT. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. PROBLEM COULD NOT BE CONFIRMED AND PROBABLE CAUSE CANNOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #212 - 3004753838-2025-265006 CRITICAL
View on MAUDE
Date of Event 2023-01-31
Patient Gender Male
Patient Age 63 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2023. ON (B)(6) 2023, WHILE AT THE GYM AND ENGAGING IN PHYSICAL ACTIVITY, THE PATIENT LOST CONSCIOUSNESS. A GYM EMPLOYEE CONTACTED EMERGENCY MEDICAL SERVICES (EMS), AND THE PATIENT WAS SUBSEQUENTLY TRANSPORTED TO THE HOSPITAL. AT THE TIME OF REPORTING, THE PATIENT WAS STABLE. DURING THE EVENT, THE CGM DISPLAYED A VALUE OF 70 MG/DL, WHILE A BG READING SHOWED 29 MG/DL, INDICATING THE DISCREPANCY. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4) DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.
Report #213 - MW5175742 CRITICAL
View on MAUDE
Date of Event 2023-01-10
Patient Gender N/A
Patient Age N/A
Device DEXCOM G7 RECIEVER (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
MY DEXCOM G7 RECEIVER US PART NUMBER MT26403-0 AND THE SKUS STK-AT-013 DID NOT ALERT ME WITH ANY KIND OF SOUND OR ALARM WHEN MY BLOOD SUGAR WENT SO LOW THAT I STARTED TO THROW UP, STARTED SHAKING AND PASSED OUT. I COULD HAVE GONE INTO A COMA.
Report #214 - MW5175908 CRITICAL
View on MAUDE
Date of Event N/A
Patient Gender Unknown
Patient Age NA
Device DEXCOM G7 SENSOR (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
I AM A TYPE 1 DIABETIC AND HAVE BEEN A USER OF YOUR DEXCOM G7 SINCE (B)(6), 2023. PRIOR TO THAT TIME, I RELIED ON A LIBRAVIEW SENSOR BUT SWITCHED ON A RECOMMENDATION FROM MY DOCTOR. FROM TIME-TO-TIME, I HAVE HAD SOME PROBLEMS WITH THE DEXCOM G7 SENSOR: "FAILURE TO PAIR'', "BRIEF SENSOR ISSUE", AND DISCREPANCIES BETWEEN SENSOR READINGS AND A FINGER STICK VALUE. I REPORTED THESE TO YOUR CUSTOMER SERVICE PEOPLE AND USUALLY RECEIVED REPLACEMENT SENSORS. HOWEVER, RECENTLY I HAVE HAD THREE SERIOUS INCIDENTS THAT HAVE DESTROYED MY TRUST IN THE RELIABILITY OF THE G7 SENSORS. THE MOST SERIOUS INCIDENT OCCURRED ON (B)(6) THIS YEAR. THE G7 SENSOR ALERTED ME TO A LOW VALUE OF 75 MG/DI. I STARTED TO INGEST CARBS, BUT THE VALUE REPORTED BY G7 DID NOT MOVE UP THE WAY I WOULD HAVE EXPECTED. WHEN I USED A "FINGER STICK' TO CROSS CHECK, THE VALUE WAS ACTUALLY 55, 20 POINTS LOWER. A FEW MINUTES LATER, I WENT INTO CONVULSIONS AND MY WIFE HAD TO CALL THE (B)(6) EMS. I WAS TAKEN TO (B)(6) HOSPITAL AND SPENT OVERNIGHT THERE. THE SECOND INCIDENT OCCURRED ABOUT TWO WEEKS AFTER I TRIED USING AN INSULIN PUMP WITH A G7 AS THE SENSOR. FOR UNKNOWN REASONS, WITH NO ALERT FROM THE SENSOR, I WOKE UP ABOUT 1 AM. I WAS SUSPICIOUS AND TOOK A "FINGER STICK" READING. IT WAS 68. NOT KNOWING WHAT THE PUMP WAS DOING (FEEDING ME INSULIN??), I DISCONNECTED THE PUMP AND STOPPED USING IT BECAUSE I COULD NOT TRUST THE SENSOR INPUT. THEN, YESTERDAY, SUNDAY, (B)(6), I HAD A SERIOUS OF READINGS ABOVE 350 AND TRENDING HIGHER. THE G7 KEPT RISING, PEAKING SOMEWHERE ABOVE 619, WHICH WAS ABSURD! THE "FINGER STICK" VALUE WAS IN THE LOW 300'S. WHEN I TRIED TO ENTER THE DATA INTO THE G7 TO "CALIBRATE " THE DEVICE, IT REFUSED THE ENTRY. A HIGH READING FROM THE SENSOR INVALIDATES THE "LOW ALERT" FUNCTION OF THE SENSOR! I HAVE 8 SENSORS ON HAND INCLUDING THE ONE I'M WEARING. I INTEND TO SWITCH TO LIBRAVIEW AS SOON I CAN GET AN RX AND INSURANCE PERMISSION TO MAKE THE SWITCH. I AM SENDING A COPY OF THIS LETTER TO THE FDA TO ALERT THEM TO WHAT I CONSIDER A SERIOUS SAFETY PROBLEM. DEVICE CODES: 1535, 3283, 2339, 2890, 1506. PATIENT CODES: 4406, 1912. REFERENCE REPORTS MW5175907, MW5175909.
Report #215 - 3004753838-2025-271927 CRITICAL
View on MAUDE
Date of Event 2025-09-16
Patient Gender Male
Patient Age 80 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. H6: HEALTH EFFECT CLINICAL CODE - MOVEMENT DISORDER. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN. ON (B)(6) 2025, IT WAS REPORTED THAT AT AROUND 4:30 PM, THE PATIENT WAS AT HOME WITH HIS WIFE WHEN HE HAD DIFFICULTY WALKING BECAUSE OF LEG PAIN. THE DEXCOM READINGS WAS "HIGH" AND THE BG FS WAS 30 MG/DL. THE WIFE ASSISTED THE PATIENT TO WALK AND SIT ON A CHAIR AND PROVIDED A COKE BUT BY THE TIME SHE WENT BACK TO HAND HIM THE COKE, THE PT WAS ALREADY HAVING A SEIZURE. THE WIFE ADMINISTERED GLUCAGON SHOT AND THE PATIENT'S SEIZURE LASTED FOR 20 MINUTES. HE WOKE UP CONFUSED AND THE WIFE TOOK A BG READING WHICH WAS 104 MG/DL WHILE THE CGM WAS READING 368 MG/DL. THEY DID NOT SEEK MEDICAL ASSISTANCE AND SAID THE PATIENT IS FEELING FINE. NO OTHER DETAILS WERE DOCUMENTED. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. WHEN THE PATIENT HAD LEG PAIN, THE REPORTED GLUCOSE VALUES FALL WITHIN THE E ZONE OF THE PARKES ERROR GRID. WHEN THE PATIENT WOKE UP, THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #216 - 3004753838-2025-272396 CRITICAL
View on MAUDE
Date of Event 2025-09-13
Patient Gender Male
Patient Age 42 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT STATED THAT THE DAY OF THE EVENT THE CGM READING WAS INACCURATE AND WAS ¿ON AND OFF¿ WHILE HE WAS ASLEEP. THE PATIENT WOKE UP DISORIENTED AND WOULD HAVE EXPERIENCED CONVULSIONS. NO SPECIFIC CGM READING WAS REPORTED, AND NO BLOOD GLUCOSE READING WAS TAKEN. NO TREATMENT WAS REPORTED BY THE PATIENT WHO REFUSED TO PROVIDE ANY FURTHER TREATMENT REGARDING THE EVENT. NO OTHER DETAILS WERE DOCUMENTED. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4).
Report #217 - 3004753838-2025-271403 CRITICAL
View on MAUDE
Date of Event 2025-09-12
Patient Gender Male
Patient Age 48 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. THE PATIENT REPORTED THAT THE WEARABLE DEVICE FAILED A FEW HOURS AFTER PLACEMENT ON THE ARM ON (B)(6) 2025. DUE TO THE FAILURE, THE PATIENT REMOVED HIS INSULET OMNIPOD5, STATING THAT IT COULD NOT OPERATE IN MODIFIED CLOSED LOOP MODE WITHOUT AN ACTIVE SENSOR SESSION. IT WAS NOT CONFIRMED WHETHER THE PATIENT WAS MONITORING BLOOD GLUCOSE VIA FINGERSTICK DURING THE INACTIVE SESSION. ON (B)(6) 2025, THE PATIENT STATED HE WAS HOSPITALIZED FOLLOWING A STROKE, WHICH HE ATTRIBUTED TO HYPERTENSION. HE EXPRESSED THAT THE STRESS CAUSED BY THE SENSOR MALFUNCTION AND INABILITY TO REGULATE HIS BLOOD GLUCOSE CONTRIBUTED TO HIS CONDITION. THE PATIENT BELIEVES THE WEARABLE FAILURE DIRECTLY IMPACTED HIS HEALTH. HE INITIALLY PRESENTED AT ONE HOSPITAL BUT WAS TRANSFERRED TO ANOTHER FACILITY DUE TO THE LACK OF MRI CAPABILITIES. SPECIFIC DETAILS REGARDING HIS SYMPTOMS, MEDICATIONS ADMINISTERED, AND THE NAMES OF THE HOSPITALS WERE NOT CAPTURED, AS THE PATIENT DISCONNECTED BEFORE THE CALL CONCLUDED. DUE DILIGENCE ATTEMPTS TO CONTACT THE REPORTER FOR MORE INFORMATION WERE ATTEMPTED BUT NOT SUCCESSFUL. DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS CONFIRMED VIA DATA. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. | (B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED.
Report #218 - 3004753838-2025-264583 CRITICAL
View on MAUDE
Date of Event 2025-09-07
Patient Gender Female
Patient Age 49 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT REPORTED SHE WAS GETTING LOW READINGS THEN SAID THE READINGS WERE NO LONGER REGISTERING. INITIALLY, THE SENSOR WAS READING LOW AND THE PATIENT DID NOT HAVE ACCESS TO FINGERSTICKS FOR VERIFICATION. NO CALIBRATION WAS DONE. THE PATIENT ATE A HANDFUL OF POPCORN. AT 3:00 AM AND 4:00 AM ON (B)(6) 2025, HER DEXCOM MOBILE APP SHOWED GLUCOSE LEVEL OF 280 MG/DL (PATIENT CANNOT RECALL EXACT TIME WHEN READINGS CAME BACK AFTER THE SENSOR ERROR). THE PATIENT WOKE UP FEELING UNWELL, EXPERIENCED VOMITING AND INTENSE CHEST PAIN, AND BELIEVED SHE MIGHT BE HAVING A HEART ATTACK. AT 6:00 AM, SHE CALLED 911 AND HER PARENTS ACCOMPANIED HER TO THE HOSPITAL. WHEN THE PARAMEDICS ARRIVED, SHE WAS BELIEVED TO BE EXPERIENCING DKA. NO FINGERSTICKS WERE TAKEN WHEN THE PARAMEDICS ARRIVED. ON THE WAY TO THE HOSPITAL, THE PARAMEDICS GAVE THE PATIENT SOME FLUIDS. UPON ARRIVAL AT THE HOSPITAL, DEXCOM CONTINUED TO SHOW 280 MG/DL, BUT A BLOOD GLUCOSE TEST REVEALED A LEVEL OF 540 MG/DL. SOME TESTS WERE DONE AND IT WAS CONFIRMED THAT THE PATIENT WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA). SHE WAS ADMINISTERED MORPHINE FOR THE CHEST PAIN, WHICH WAS LATER IDENTIFIED AS SORENESS. SHE ALSO SAID THAT SHE GIVEN AN INSULIN DRIP, AND WAS ADMITTED TO THE ICU FOR APPROXIMATELY 9¿10 HOURS UNTIL HER BLOOD GLUCOSE LEVEL STABILIZED AT 130 MG/DL. THE PATIENT WAS CONFINED FOR ABOUT 24 HOURS AND WAS DISCHARGED ON (B)(6). AT THE TIME OF THE CALL, SHE WAS FEELING BETTER. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS.
Report #219 - 3004753838-2025-266973 CRITICAL
View on MAUDE
Date of Event 2025-09-06
Patient Gender Male
Patient Age 68 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. PLEASE DISREGARD H6 HEALTH EFFECT CLINICAL CODE - 4582 NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AS THIS CODES ARE NOT APPLICABLE FOR THIS REPORT. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. THE DATE OF THE EVENT IS AN APPROXIMATION. THE PATIENT'S SPOUSE REPORTED RECEIVING A TEXT MESSAGE FROM THE PATIENT INDICATING AN ESTIMATED GLUCOSE VALUE (EGV) OF 71 MG/DL, AND THAT HE PLANNED TO EAT. THIS OCCURRED FOUR DAYS AFTER THE SENSOR WAS PLACED ON THE PATIENT'S ARM. ACCORDING TO THE SPOUSE, ALTHOUGH THE EGV WAS 71 MG/DL AT THE TIME, SHE BELIEVED THE ACTUAL GLUCOSE LEVEL WAS LOWER, ESPECIALLY CONSIDERING THE PATIENT EXHIBITED NO SYMPTOMS PRIOR TO LOSING CONSCIOUSNESS. IT IS UNKNOWN WHETHER A FINGERSTICK READING WAS TAKEN FOR COMPARISON. BOTH OF THE PATIENT¿S PRIMARY DISPLAY DEVICES SHOWED THE SAME EGV, AND THE SPOUSE WAS ABLE TO VIEW THE PATIENT¿S DATA VIA THE DEXCOM FOLLOW APP. NO FURTHER UPDATES WERE RECEIVED AFTER THE INITIAL TEXT MESSAGE. ON THE MORNING OF SATURDAY, (B)(6) 2025, THE PATIENT CALLED HIS SPOUSE BUT WAS NOT SPEAKING COHERENTLY. THE FOLLOW APP INDICATED AN UNSPECIFIED LOW GLUCOSE READING, AND NO FINGERSTICK WAS TAKEN AT THAT TIME. PER TECHNICAL SUPPORT (TS), THE SPOUSE DID NOT PROVIDE A SPECIFIC GLUCOSE VALUE. THE SPOUSE THEN CONTACTED HER DAUGHTER TO CHECK ON THE PATIENT. UPON ARRIVAL, THE DAUGHTER FOUND THE PATIENT AWAKE BUT NON-VERBAL AND SITTING ON THE FLOOR IN A BLANKED-OUT STATE. A BLOOD GLUCOSE TEST SHOWED A READING OF 42 MG/DL. THE DAUGHTER ADMINISTERED A GLUCAGON INJECTION AND CALLED EMERGENCY SERVICES. THERE WERE NO REPORTED ERROR MESSAGES FROM THE CGM DEVICE PRIOR TO OR DURING THE EVENT. WHEN PARAMEDICS ARRIVED, THEY MEASURED THE PATIENT¿S BLOOD GLUCOSE AT 22 MG/DL. THE CGM READING AT THAT TIME IS UNKNOWN. THE SPOUSE COULD NOT RECALL WHETHER ANY TREATMENTS OR MEDICATIONS WERE ADMINISTERED BY THE PARAMEDICS. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL ON THE SAME DAY. DUE TO CONCERNS OF A POSSIBLE STROKE, MEDICAL TESTS INCLUDING AN EKG AND CT SCAN WERE PERFORMED. ACCORDING TO THE SPOUSE, THE HOSPITAL NOTED DISCREPANCIES BETWEEN THE CGM READINGS AND ACTUAL BLOOD GLUCOSE LEVELS, WITH EGVS REPORTEDLY OFF BY 50¿100 MG/DL. THE HOSPITAL ALSO DIAGNOSED THE PATIENT WITH DEHYDRATION. THE PATIENT WAS DISCHARGED ON 09/09/2025, WITH BLOOD GLUCOSE LEVELS REPORTED AS NORMAL. DURING A FOLLOW-UP CALL, THE PATIENT REPORTED DIFFICULTY PAIRING A NEW G7 SENSOR. AFTER SUCCESSFULLY APPLYING THE NEW SENSOR AND COMPLETING THE WARM-UP PERIOD, THE CGM DISPLAYED A READING OF 176 MG/DL. NO FINGERSTICK COMPARISON WAS PERFORMED AT THAT TIME. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION DURING THE CALL. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. IT HAS BEEN REPORTED THAT THERE WAS A DIFFERENCE IN READINGS OF 50-100 MGDL OFF. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #220 - 3004753838-2025-261948 CRITICAL
View on MAUDE
Date of Event 2025-09-05
Patient Gender N/A
Patient Age N/A
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. ACCORDING TO THE PATIENT¿S SPOUSE, ON (B)(6) 2025 AROUND 1:30 AM, THE PATIENT¿S WIFE WOKE UP AND FOUND THE PATIENT EXPERIENCING A SEIZURE. SHE IMMEDIATELY CHECKED THE G7 APP AND SAW LOW ALERTS BUT NO ALERT SOUND WAS HEARD. SHE DID NOT ADMINISTER ANY TREATMENT AND IMMEDIATELY CALLED FOR AN AMBULANCE. WHILE WAITING FOR THE AMBULANCE TO ARRIVE, THE WIFE PROVIDED PHYSICAL SUPPORT BY HOLDING HIS HEAD AND BODY TO PREVENT THE PATIENT FROM BUMPING INTO OR HITTING ANY OBJECTS DURING THE SEIZURE. THEN AFTER 25 TO 30 MINUTES, PARAMEDICS ARRIVED. THEY PERFORMED A FINGERSTICK BLOOD GLUCOSE TEST, WHICH REVEALED A GLUCOSE LEVEL OF 35 MG/DL, CONSISTENT WITH A LOW (LESS THAN 40 MG/DL) READING ON THE G7 APP. IN RESPONSE, THE PARAMEDICS ADMINISTERED 1½ BAGS OF IV FLUID TO STABILIZE THE PATIENT. WITHIN A FEW MINUTES, THE SEIZURE STOPPED, AND THE PATIENT BEGAN TO STABILIZE. THE PARAMEDICS AND REPORTER THEN PROVIDED A GLASS OF MILK AND A PEANUT BUTTER SANDWICH TO HELP MAINTAIN GLUCOSE LEVELS. THE PATIENT REMAINED STABLE AND FINGERSTICK TESTS WERE CONDUCTED EVERY 10¿15 MINUTES, WITH THE FOLLOWING RESULTS OF 38 MG/DL, 70 MG/DL, 120 MG/DL AND 170 MG/DL WHICH THE G7 APP ALSO SHOWED 168 MG/DL. BASED ON THESE READINGS, PARAMEDICS CONFIRMED THAT THE PATIENT WAS STABLE AND DID NOT REQUIRE HOSPITAL TRANSPORT. THEY ALSO ADVISED THE REPORTER TO CONTINUE MONITORING THE PATIENT¿S GLUCOSE LEVELS CLOSELY TO ENSURE ONGOING STABILITY. AT THE TIME OF THE REPORT THE PATIENT WAS FEELING BETTER. DATA HAS BEEN REQUESTED BUT IS PENDING EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.
Report #221 - 3004753838-2025-256498 CRITICAL
View on MAUDE
Date of Event 2025-09-02
Patient Gender Female
Patient Age 28 MO
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4) DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. | IT WAS REPORTED THAT NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025 AROUND 03:00AM, THE PEDIATRIC PATIENT EXPERIENCED CONVULSIONS. THE REPORTER HEARD THE PATIENT CRYING, AND WHEN THEY CHECKED ON THE BABY, THEY FOUND THEM CONVULSING. THE REPORTER DID NOT HEAR ANY ALERTS AS THEY WERE ASLEEP. THE PATIENT WAS TREATED WITH GLUCOSE SUPPLEMENTS. NO FURTHER TREATMENT WAS REPORTED TO BE NEEDED AND THE PATIENT DID NOT GO TO THE HOSPITAL. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. PROBLEM COULD NOT BE CONFIRMED AND PROBABLE CAUSE CANNOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #222 - 3004753838-2025-262507 CRITICAL
View on MAUDE
Date of Event 2025-08-25
Patient Gender Female
Patient Age 47 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT STATED THE CGM WAS 110 MG/DL AND THE BG WA 36 MG/DL. SHE STATED SHE DID NOT HEAR ANY ALARMS OR ALERTS ON THE CGM (IT IS NOT KNOWN WHAT THE PATIENT'S LOW ALERT SETTING WAS AT). THE PATIENT HAD A SEIZURE AFTER CHECKING THE BG READING. SHE TOOK A GLUCOSE TABLET AFTERWARDS AND FELT OKAY. SHE CALLED HER DOCTOR WAS THE DOCTOR DID NOT ADVERSE HER TO GO TO THE HOSPITAL SINCE SHE HAD ALREADY TREATED HER LOW BLOOD GLUCOSE. AT THE TIME OF THE REPORT, THE PATIENT WAS IN STABLE CONDITION. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #223 - 3004753838-2025-258802 CRITICAL
View on MAUDE
Date of Event 2025-08-24
Patient Gender Female
Patient Age 24 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON APPROXIMATELY (B)(6) 2025, THE PATIENT'S CGM WAS READING 100 MG/DL AND THE PATIENT WAS "FEELING FINE". THE PATIENT WAS WEARING AN OMNIPOD INSULIN PUMP. THE PATIENT TOOK HER SON TO A SCHEDULED DOCTOR¿S APPOINTMENT AND THEN WENT TO THE STORE. AT THE STORE, THE PATIENT FELL AND HAD A SEIZURE. THE PATIENT'S CGM WAS READING 90 MG/DL. NO BG METER COMPARISON VALUE WAS TAKEN AT THIS TIME. EMS WAS CALLED. ONCE EMS ARRIVED, THE PATIENT'S BG METER READING WAS 40 MG/DL WHILE THE CGM WAS STILL READING 90 MG/DL. THE PATIENT WAS TRANSPORTED TO THE ER WHERE SHE WAS TREATED WITH GLUCOSE GEL. SHE REPORTED THAT SHE WAS GIVEN IV FLUIDS FOR 4.5 HOURS. AFTER TREATMENT, THE PATIENT'S BG METER READING INCREASED TO 170 MG/DL AND THE CGM WAS READING 190 MG/DL. THE PATIENT WAS DISCHARGED THE SAME DAY. THE PATIENT WAS "OKAY" AT THE TIME OF REPORT. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID WHEN PARAMEDICS ARRIVED. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #224 - MW5175909 CRITICAL
View on MAUDE
Date of Event 2025-08-24
Patient Gender Unknown
Patient Age NA
Device DEXCOM G7 SENSOR (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
I AM A TYPE 1 DIABETIC AND HAVE BEEN A USER OF YOUR DEXCOM G7 SINCE (B)(6), 2023. PRIOR TO THAT TIME, I RELIED ON A LIBRAVIEW SENSOR BUT SWITCHED ON A RECOMMENDATION FROM MY DOCTOR. FROM TIME-TO-TIME, I HAVE HAD SOME PROBLEMS WITH THE DEXCOM G7 SENSOR: "FAILURE TO PAIR'', "BRIEF SENSOR ISSUE", AND DISCREPANCIES BETWEEN SENSOR READINGS AND A FINGER STICK VALUE. I REPORTED THESE TO YOUR CUSTOMER SERVICE PEOPLE AND USUALLY RECEIVED REPLACEMENT SENSORS. HOWEVER, RECENTLY I HAVE HAD THREE SERIOUS INCIDENTS THAT HAVE DESTROYED MY TRUST IN THE RELIABILITY OF THE G7 SENSORS. THE MOST SERIOUS INCIDENT OCCURRED ON (B)(6) THIS YEAR. THE G7 SENSOR ALERTED ME TO A LOW VALUE OF 75 MG/DI. I STARTED TO INGEST CARBS, BUT THE VALUE REPORTED BY G7 DID NOT MOVE UP THE WAY I WOULD HAVE EXPECTED. WHEN I USED A "FINGER STICK' TO CROSS CHECK, THE VALUE WAS ACTUALLY 55, 20 POINTS LOWER. A FEW MINUTES LATER, I WENT INTO CONVULSIONS AND MY WIFE HAD TO CALL THE (B)(6) EMS. I WAS TAKEN TO (B)(6) HOSPITAL AND SPENT OVERNIGHT THERE. THE SECOND INCIDENT OCCURRED ABOUT TWO WEEKS AFTER I TRIED USING AN INSULIN PUMP WITH A G7 AS THE SENSOR. FOR UNKNOWN REASONS, WITH NO ALERT FROM THE SENSOR, I WOKE UP ABOUT 1 AM. I WAS SUSPICIOUS AND TOOK A "FINGER STICK" READING. IT WAS 68. NOT KNOWING WHAT THE PUMP WAS DOING (FEEDING ME INSULIN??), I DISCONNECTED THE PUMP AND STOPPED USING IT BECAUSE I COULD NOT TRUST THE SENSOR INPUT. THEN, YESTERDAY, SUNDAY, (B)(6), I HAD A SERIOUS OF READINGS ABOVE 350 AND TRENDING HIGHER. THE G7 KEPT RISING, PEAKING SOMEWHERE ABOVE 619, WHICH WAS ABSURD! THE "FINGER STICK" VALUE WAS IN THE LOW 300'S. WHEN I TRIED TO ENTER THE DATA INTO THE G7 TO "CALIBRATE " THE DEVICE, IT REFUSED THE ENTRY. A HIGH READING FROM THE SENSOR INVALIDATES THE "LOW ALERT" FUNCTION OF THE SENSOR! I HAVE 8 SENSORS ON HAND INCLUDING THE ONE I'M WEARING. I INTEND TO SWITCH TO LIBRAVIEW AS SOON I CAN GET AN RX AND INSURANCE PERMISSION TO MAKE THE SWITCH. I AM SENDING A COPY OF THIS LETTER TO THE FDA TO ALERT THEM TO WHAT I CONSIDER A SERIOUS SAFETY PROBLEM. DEVICE CODES: 1535, 3283, 2339, 2890, 1506. PATIENT CODES: 4406, 1912. REFERENCE REPORTS MW5175907, MW5175908.
Report #225 - 3004753838-2025-260395 CRITICAL
View on MAUDE
Date of Event 2025-08-22
Patient Gender Male
Patient Age 59 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM, WHICH IS OFF-LABEL USAGE OF THE DEVICE. ON (B)(6) 2025, THE PATIENT STOOD UP AND SUDDENLY COLLAPSED. AT THE TIME OF THE INCIDENT, BOTH HIS CGM RECEIVER AND MOBILE DEVICE DISPLAYED A BLOOD GLUCOSE READING OF 80 MG/DL, WHILE A FINGERSTICK (FS) TEST SHOWED A LOWER VALUE OF 40 MG/DL. DURING THE FALL, THE PATIENT STRUCK THE CORNER OF A TABLE AND LOST CONSCIOUSNESS FOR APPROXIMATELY FIVE MINUTES. UPON REGAINING CONSCIOUSNESS, THE PATIENT DECLINED TO CALL EMERGENCY SERVICES AND DID NOT TAKE ANY MEDICATION AT THAT TIME. THERE IS NO DOCUMENTATION REGARDING THE TREATMENT OR MANAGEMENT OF HYPOGLYCEMIA IMMEDIATELY FOLLOWING THE EVENT. AFTER A BRIEF PERIOD OF REST, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) AND WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR TWO DAYS, FOLLOWED BY A ONE-DAY STAY IN A REGULAR HOSPITAL ROOM. HE WAS DIAGNOSED WITH FACIAL BONE FRACTURES AND INTRACRANIAL BLEEDING. DURING HOSPITALIZATION, THE PATIENT RECEIVED INTRAVENOUS FLUIDS AND WAS ADMINISTERED KEPPRA AND TYLENOL. BLOOD SAMPLES WERE COLLECTED FOR FURTHER EVALUATION. THE PATIENT HAS SINCE BEEN DISCHARGED AND CONTINUES TO ATTEND FOLLOW-UP APPOINTMENTS. HE IS UNDERGOING A SERIES OF TESTS TO ASSESS THE NEED FOR POTENTIAL SURGERY AND TO FINALIZE A CARE PLAN, WHICH REMAINS CONTINGENT UPON THE TEST RESULTS. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #226 - 3004753838-2025-251820 CRITICAL
View on MAUDE
Date of Event 2025-08-20
Patient Gender Male
Patient Age 74 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON (B)(6) 2025, THE CGM WAS READING 300 MG/DL AND THE PATIENT DID NOT HAVE ANY SYMPTOMS. HE TOOK 12 UNITS OF BASAGLAR (LONG ACTING INSULIN) BUT THE CGM CONTINUED TO SHOW 300 MG/DL. NO FINGER STICK READING WAS TAKEN. AT 7:30AM, THE PATIENT'S WIFE COULD NOT WAKE HIM SO SHE CALLED 911. WHEN PARAMEDICS ARRIVED, THE PATIENT'S BG WAS 24 MG/DL AND THE CGM WAS 400 MG/DL. THE PATIENT WAS TREATED WITH IV THERAPY. ANOTHER FINGER STICK READING WAS 80 MG/DL, THE PATIENT COULD NOT REMEMBER WHAT THE CGM READING WAS. LATER IN THE DAY, THE PATIENT REPLACED THE SENSOR AND THAT SENSOR CONTINUED TO READ 400 MG/DL. AT THE TIME OF THE REPORT, THE PATIENT WAS DOING FINE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE E ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.
Report #227 - 3004753838-2025-249868 CRITICAL
View on MAUDE
Date of Event 2025-08-19
Patient Gender Female
Patient Age 41 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SEIZURE. AN AMBULANCE WAS CALLED BY THE PATIENT´S DAUGHTER. WHEN A FINGERSTICK WAS TAKEN THE BLOOD GLUCOSE READING WAS 33 MG/DL AND THE CGM DEVICE WAS SHOWING A SENSOR FAILURE AT THAT MOMENT. WHEN THE PARAMEDICS ARRIVED, IT WAS CONFIRMED THAT THE PATIENT´S BLOOD GLUCOSE LEVEL WAS CRITICALLY LOW. THE PATIENT WAS TREATED WITH A GLUCAGON INJECTION AND WAS BROUGHT TO THE HOSPITAL. AT THE HOSPITAL THE PATIENT RECEIVED INTRAVENOUS TREATMENT. AFTER TREATMENT THE BLOOD GLUCOSE READING WAS 132 MG/DL. THE PATIENT WAS DISCHARGED THE DAY AFTER, AND THE BLOOD GLUCOSE READING WAS 206 MG/DL. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS CONFIRMED VIA DATA. THE PROBABLE CAUSE WAS DETERMINED TO BE VERY LOW COUNT ABERRATION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.
Report #228 - 3004753838-2025-250211 CRITICAL
View on MAUDE
Date of Event 2025-08-18
Patient Gender Male
Patient Age 16 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE UPPER BUTTOCKS ON (B)(6) 2025. ACCORDING TO THE PATIENT¿S PARENT, ON (B)(6) 2025, AROUND 12:30 AM, THE PATIENT'S NEW SENSOR FINISHED ITS WARM-UP PERIOD AND THE CGM VALUE WAS 200-300 MG/DL. NO BG METER COMPARISON VALUE WAS TAKEN. THE PATIENT WAS WEARING AN OMNIPOD INSULIN PUMP AND THE PUMP ADMINISTERED ADDITIONAL INSULIN FOR THE ELEVATED CGM VALUE. AT AN UNSPECIFIED TIME LATER, THE PATIENT¿S CGM WAS REPORTEDLY READING 30 MG/DL. HOWEVER, THE CGM DEVICE CANNOT PROVIDE A NUMERICAL VALUE BELOW 40 MG/DL. THE PATIENT SELF-TREATED THE 30 MG/DL (SPECIFICS WERE NOT PROVIDED). AT AN UNSPECIFIED TIME LATER, THE PATIENT¿S CGM VALUE WAS ¿HIGH¿ (NO SPECIFIC VALUE WAS REPORTED) AND THIS IS WHEN THE PATIENT EXPERIENCED A SEIZURE. EMERGENCY MEDICAL SERVICES (EMS) WAS CALLED. ONCE EMS ARRIVED, NO CGM OR BG METER READINGS WERE REPORTED. EMS TREATED THE PATIENT WITH NASAL GLUCAGON. AT AN UNSPECIFIED TIME AFTER TREATMENT, THE PATIENT¿S BG METER READING WAS 72 MG/DL WHILE THE CGM WAS READING LOW. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM (ER). AT THE ER, THE PATIENT¿S BG LEVELS WERE MONITORED AND IT WAS FOUND THAT THE CGM WAS ¿60 POINTS OFF¿ FROM THE PATIENT¿S BG METER READINGS. THE PATIENT WAS TREATED WITH TYLENOL DUE TO A HEADACHE POST SEIZURE AND WAS THEN DISCHARGED AFTER APPROXIMATELY THREE HOURS. THE PATIENT WAS STILL ¿NOT FEELING GOOD¿ AT THE TIME OF REPORT. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.
Report #229 - 3004753838-2025-246955 CRITICAL
View on MAUDE
Date of Event 2025-08-18
Patient Gender Female
Patient Age 25 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. ON (B)(6) 2025, WHILE AT WORK, THE PATIENT STARTED TO FEEL LOW (NO SPECIFIC SYMPTOMS WERE REPORTED). THE PATIENT¿S CGM WAS READING 100 MG/DL WHILE THE BG METER WAS READING 50 MG/DL. THE PATIENT WAS WEARING AN OMNIPOD INSULIN PUMP. THE PATIENT STARTED TO HAVE A SEIZURE AND A COWORKER CALLED EMERGENCY MEDICAL SERVICES (EMS). EMS ARRIVED AND TRANSPORTED THE PATIENT TO THE EMERGENCY ROOM. THE PATIENT COULD NOT RECALL IF A BG METER READING WAS TESTED OR WHAT HER CGM VALUE WAS AT THIS TIME. AT THE ER, THE PATIENT¿S BG METER READING WAS TAKEN AND FOUND TO BE LOWER THAN THE PATIENT¿S CGM VALUE, HOWEVER, NO SPECIFIC VALUES WERE REPORTED. THE PATIENT¿S SENSOR AND OMNIPOD WERE REMOVED. THE PATIENT REFUSED TO PROVIDE ANY SPECIFIC DETAILS ABOUT THE MEDICATION OR TREATMENT PROVIDED TO HER. SHE WAS DISCHARGED HOME AFTER 2 DAYS. THE PATIENT WAS ¿FINE¿ AT THE TIME OF REPORT. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.
Report #230 - 3004753838-2025-245395 CRITICAL
View on MAUDE
Date of Event 2025-08-18
Patient Gender Female
Patient Age 50 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ACCORDING TO THE PATIENT, ON (B)(6) 2025, THE PATIENT WAS AT WORK WHEN SHE EXPERIENCED HYPOGLYCEMIA. WHEN SHE CHECKED HER CGM IT WAS 107 MG/DL AND SHE BEGAN TO FEEL WEIRD, SWEATING AND EXPERIENCED A SEIZURE. HER BOSS THEN CALLED THE PARAMEDICS. WHEN PARAMEDICS ARRIVED, THEY TOOK A BG READING, IT WAS 27 MG/DL WHILE THE CGM WAS 104 MG/DL. THE PATIENT WAS TREATED WITH 2 INTRAVENOUS (IV) GLUCOSE AND 1 SUGAR GEL IN HER MOUTH. AFTER A FEW MINUTES, THE PATIENT BEGAN TO FEEL OK. THE PARAMEDICS DID ANOTHER FINGER STICK AND THE BG METER WAS 130 MG/DL. THE PATIENT THEN PUT A NEW SENSOR ON, AND PARAMEDICS TOOK A BG 166 MG/DL AND THE DEXCOM CGM METER 170 MG/DL. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID WAS TAKEN WHEN THE PARAMEDICS ARRIVED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE A ZONE OF THE PARKES ERROR GRID WAS TAKEN WITH THE NEW SENSOR SESSION. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #231 - 3004753838-2025-245636 CRITICAL
View on MAUDE
Date of Event 2025-08-17
Patient Gender Male
Patient Age 21 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. ACCORDING TO THE PATIENT¿S PARENT, ON APPROXIMATELY (B)(6) 2025, THE PATIENT¿S INSULIN PUMP ADMINISTERED 23 UNITS OF INSULIN BASED ON AN INACCURATE HIGH CGM READING, CAUSING THE PATIENT TO EXPERIENCE A SEIZURE. THE EMERGENCIES WERE CALLED, AND THE PATIENT WAS TREATED WITH THE ¿HYPO KIT¿, WHICH WAS UNDERSTOOD AS TREATMENT WITH GLUCAGON. THE BLOOD GLUCOSE READING WAS 4.1 MMOL/L AT AN UNKNOWN TIME. THE PATIENT WAS BROUGHT TO THE HOSPITAL AND WHEN A FINGERSTICK WAS TAKEN THERE THE CGM READING WAS HIGH (MORE THAN 22.2 MMOL/L) WITH 2 ARROWS POINTING UP, AND THE BLOOD GLUCOSE READING WAS 13.5 MMOL/L. NO FURTHER TREATMENT WAS REPORTED TO BE NEEDED, AND IT WAS UNKNOWN HOW MUCH TIME THE PATIENT SPENT AT THE HOSPITAL. THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. DATA WAS EVALUATED, AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #232 - 3004753838-2025-240840 CRITICAL
View on MAUDE
Date of Event 2025-08-17
Patient Gender Male
Patient Age 47 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ACCORDING TO THE PATIENT, ON (B)(6) 2025, THE PATIENT STARTED HIS SESSION EARLY THAT MORNING AT 4:30 AM. AROUND 7:30 AM, HE WENT TO THE BATHROOM, NOT REALIZING THAT HIS BLOOD GLUCOSE WAS LOW. HE DID NOT REMEMBER IF HIS DEXCOM RECEIVER ALERTED HIM AND HE EXPERIENCED A SEIZURE. HIS MOTHER, WHO IS A NURSE BY PROFESSION, WAS ASLEEP UPSTAIRS. SHE WAS SUDDENLY AWAKENED BY A SCREAM OR YELL FROM THE BATHROOM. WHEN SHE GOT TO THE BATHROOM, SHE FOUND HIM IN THE MIDDLE OF A FULL CONVULSION THAT LASTED ABOUT 30 TO 40 MINUTES. HE WAS TRYING TO STAND UP DURING THE SEIZURE, BUT SHE STOPPED HIM BECAUSE SHE KNEW HE COULD HURT HIMSELF. DESPITE HER EFFORTS, HE FELL BACKWARD, HITTING THE BASE OF THE TOILET WITH HIS BACK AND SMACKING HIS HEAD AGAINST THE TOILET ITSELF, CAUSING A BLEEDING INJURY. BEFORE SHE REACHED HIM, HE MUST HAVE ALREADY HIT THE FRONT OF HIS HEAD AS WELL BECAUSE HE WAS BLEEDING FROM THERE TOO. SHE QUICKLY APPLIED A BANDAGE TO HIS HEAD TO STOP THE BLEEDING. AFTER THE SEIZURE, SHE WAS ABLE TO GET HIM TO SIT IN A CHAIR, AND SHE GAVE HIM SOME SUGAR IN THE FORM OF REESE¿S PEANUT BUTTER CUPS. HE THEN FELL ASLEEP, TOO EXHAUSTED FROM THE SEIZURE TO SPEAK OR RESPOND TO HER. THE DEXCOM SENSOR WAS STILL ATTACHED TO HIS ARM BUT WAS ABOUT TO COME OFF, LIKELY BUMPED DURING THE SEIZURE AND IT WAS SHOWING A SENSOR FAILURE. THE PATIENT WAS DIAPHORETIC, BREAKING OUT IN SWEAT, FELT TERRIBLE, HURT ALL OVER, AND HAD A HEADACHE. THERE WAS NO AMBULANCE CALLED. NO OTHER DETAILS WERE DOCUMENTED. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. PROBLEM COULD NOT BE CONFIRMED AND PROBABLE CAUSE CANNOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED.
Report #233 - 3004753838-2025-256886 CRITICAL
View on MAUDE
Date of Event 2025-08-16
Patient Gender Male
Patient Age 28 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. ACCORDING TO THE PATIENT, ON APPROXIMATELY (B)(6) 2025, THE PATIENT EXPERIENCED INACCURATE CGM VALUES, WHICH CAUSED THEIR TANDEM INSULIN PUMP TO DELIVER AN AUTOMATIC CORRECTION BOLUS THAT WAS NOT NEEDED. THIS THEN LED TO THE PATIENT HAVING A HYPOGLYCEMIC SEIZURE WHICH RESULTED IN AN ER VISIT. THERE WAS NO DOCUMENTATION PROVIDED ON WHAT MEDICATION OR TREATMENT THE PATIENT MAY HAVE RECEIVED. IT WAS ALSO NOT SPECIFIED HOW LONG THE PATIENT WAS IN THE ER PRIOR TO BEING DISCHARGED. ATTEMPTS TO REACH THE PATIENT FOR FURTHER EVENT CLARIFICATION WERE UNSUCCESSFUL. NO OTHER PATIENT OR EVENT DETAILS WERE AVAILABLE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.
Report #234 - 3004753838-2025-247379 CRITICAL
View on MAUDE
Date of Event 2025-08-16
Patient Gender Female
Patient Age 88 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ACCORDING TO THE REPORTER, ON APPROXIMATELY (B)(6) 2025, THE CGM WAS DISPLAYING 74 MG/DL WHILE THE BG WAS 40 MG/DL. AT THE TIME THE PATIENT WAS LAYING IN BED WHEN THE PATIENT EXPERIENCED SWEATING AND SEIZURE. WHEN THE CAREGIVER ARRIVED, SHE SAW THE PATIENT HAVING A SEIZURE IN BED AND CALLED EMERGENCY MEDICAL SERVICES (EMS). WHEN EMS ARRIVED, THEY TOOK THE PATIENT¿S BG, WHICH WAS 40 MG/DL AND THE CGM WAS 74 MG/DL. THE CALLER IS UNABLE TO RECALL IF EMS PROVIDED MEDICATION OR FIRST AID TO THE PATIENT. EMS RUSHED THE PATIENT TO THE HOSPITAL. UPON ARRIVAL, THE PATIENT¿S BG WAS CHECKED AND WAS 26 MG/DL, NO CGM VALUE WAS PROVIDED. THE REPORTER IS UNABLE TO PROVIDE ANY ADDITIONAL DETAILS OF WHEN THE PATIENT WAS IN THE HOSPITAL. AT THE TIME OF THE REPORT, THE PATIENT WAS STILL IN THE HOSPITAL. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.
Report #235 - 3004753838-2025-245181 CRITICAL
View on MAUDE
Date of Event 2025-08-15
Patient Gender Female
Patient Age 19 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT BEGAN VOMITING, COULD NOT HOLD ANYTHING DOWN, AND WAS DISORIENTED. THE PATIENT¿S CGM WAS READING 40 MG/DL. NO BG METER COMPARISON VALUE WAS TAKEN AT THIS TIME. THE PATIENT WAS WEARING AN OMNIPOD INSULIN PUMP. THE PATIENT¿S PARENT GAVE HER APPLE JUICE AS TREATMENT. A FEW MINUTES LATER, THE PATIENT DECIDED TO TEST HER BG METER READING, WHICH WAS OVER 600 MG/DL. THE PATIENT THEN COLLAPSED AND THE PATIENT¿S PARENT CALLED 911. EMERGENCY MEDICAL SERVICES ARRIVED AND THE PATIENT¿S BG METER READING WAS TAKEN AND WAS CONFIRMED TO BE HIGH BUT THE SPECIFIC VALUE COULD NOT BE RECALLED. SHE WAS THEN TRANSPORTED TO THE EMERGENCY ROOM. AT THE ER, THE PATIENT WAS TREATED WITH AN IV INSULIN DRIP. SHE WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND RECEIVED HOURLY BG METER TESTS. THE PATIENT¿S BG LEVEL TOOK SEVERAL HOURS TO START DECREASING. THE PATIENT WAS DISCHARGED AFTER TWO DAYS. THE PATIENT WAS ¿DOING WELL¿ AT THE TIME OF REPORT. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #236 - 3004753838-2025-239589 CRITICAL
View on MAUDE
Date of Event 2025-08-15
Patient Gender Male
Patient Age 81 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. IT WAS INDICATED THAT THE PATIENT WAS CRITICALLY ILL WHILE USING THE DEVICE, WHICH IS MISUSE OF THE DEVICE. ON APPROXIMATELY (B)(6) 2025, THE PATIENT EXPERIENCED HYPOGLYCEMIC SEIZURES. WHEN A FINGERSTICK WAS TAKEN THE CGM READING WAS 171 MG/DL, AND THE BLOOD GLUCOSE READING WAS 72 MG/DL. NO FURTHER INFORMATION REGARDING THE EVENT WAS REPORTED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALLS WITHIN THE C ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #237 - 3004753838-2025-239726 CRITICAL
View on MAUDE
Date of Event 2025-08-14
Patient Gender Male
Patient Age 47 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT CONTACTED EMERGENCY SERVICES AFTER EXPERIENCING SEIZURES, WEAKNESS, AND SHAKINESS. THESE SYMPTOMS FOLLOWED AN INACCURATE DEXCOM CGM READING OF 200 MG/DL, WHICH LED TANDEM TO ADMINISTER INSULIN. THE PATIENT PERFORMED A FINGER STICK TEST AND FOUND HER BLOOD GLUCOSE TO BE CRITICALLY LOW AT 44 MG/DL. HE USED AN INSULIN INHALER (NO INFORMATION WHY INSULIN WAS USED DURING A SEVERE HYPOGLYCEMIA) AND CALLED 911. WHEN 911 ARRIVED CGM REMAIN AT 200 MG/DL NO CHANGES AFTER CALIBRATION AND THE BG WAS 44 MG/DL. UPON ARRIVAL AT THE HOSPITAL THE BG WAS 44 MG/DL AND NO CGM READINGS. LABORATORY TESTS WERE CONDUCTED AND IV FLUIDS FOR DEHYDRATION ( SALINE ) WERE ADMINISTERED TO STABILIZE HIS CONDITION. AFTER A 24-HOUR STAY, SHE WAS DISCHARGED WITH INSTRUCTIONS TO CONTINUE USING HER CGM FOR MONITORING. THE PATIENT WAS DOING BETTER AT THE TIME OF THE REPORT. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID CALCULATOR. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR WAS TAKEN IN THE HOSPITAL. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #238 - 3004753838-2025-243684 CRITICAL
View on MAUDE
Date of Event 2025-08-13
Patient Gender Male
Patient Age 25 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND SEIZURE. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT¿S CGM READING WAS 40 MG/DL, PROMPTING THE PATIENT¿S MOTHER TO CONTACT THEIR PHYSICIAN. NO FURTHER INFORMATION WAS AVAILABLE REGARDING THE OUTCOME OF THAT CALL. INITIALLY, CGM READINGS APPEARED TO IMPROVE, BUT ON THE NIGHT OF (B)(6) 2025, THE CGM AGAIN SHOWED 40 MG/DL, WHILE A BLOOD GLUCOSE (BG) READING WAS 100 MG/DL. AT MIDNIGHT (B)(6) 2025), THE CGM READING WAS 70 MG/DL, AND THE BG READING WAS 134 MG/DL. AT APPROXIMATELY 01:30 AM, THE PATIENT EXPERIENCED A SEIZURE WHILE WITH THEIR GIRLFRIEND, WHO RECORDED A VIDEO OF THE EVENT. NO TREATMENT WAS REPORTED AT THAT TIME. A SECOND SEIZURE OCCURRED AT 07:00 AM. THE CGM READINGS DURING THIS TIME WERE NOT DOCUMENTED, THOUGH THE DEVICE WAS REPORTEDLY FUNCTIONING AND PROVIDING DATA THROUGHOUT THE NIGHT. AT AN UNSPECIFIED TIME DURING THE EVENT, THE PATIENT¿S GIRLFRIEND ADMINISTERED GATORADE, CRACKERS, AND A MEAL CONTAINING CARBOHYDRATES AND PROTEIN, WHICH HELPED THE PATIENT RECOVER. ALTHOUGH NOT CONFIRMED, THE SYMPTOMS AND RESPONSE SUGGEST THE PATIENT¿S BG MAY HAVE BEEN IN A HYPOGLYCEMIC RANGE DURING THE SEIZURES. FOLLOWING TREATMENT AND CALIBRATION: AT 10:00 AM, CGM READING WAS 310 MG/DL, BG WAS 250 MG/DL. AT 01:00 PM, CGM READING WAS 165 MG/DL, BG WAS 150 MG/DL. AT 06:00 PM, CGM READING WAS 310 MG/DL, BG WAS 205 MG/DL. THE PATIENT¿S PHYSICIAN INSTRUCTED A CHANGE IN INSULIN SETTINGS ON THE OMNIPOD DEVICE, INCREASING THE DOSAGE FROM 150 TO 200 UNITS VIA PHONE CONSULTATION. NO FURTHER MEDICAL EVALUATION OR INTERVENTION WAS DOCUMENTED. AT THE TIME OF REPORTING, THE PATIENT WAS STABLE, AND NO OTHER HEALTH ISSUES WERE NOTED THAT COULD HAVE CONTRIBUTED TO THE SEIZURES. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR ON (B)(6) 2025. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID ON (B)(6) 2025. THE REPORTED GLUCOSE VALUES FALL WITHIN THE A AND B ZONES OF THE PARKES ERROR GRID ON (B)(6) 2025. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #239 - 3004753838-2025-239071 CRITICAL
View on MAUDE
Date of Event 2025-08-12
Patient Gender Male
Patient Age 66 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE DATE OF EVENT IS AN APPROXIMATION. ON THE NIGHT OF (B)(6) 2025, THE PATIENT EXPERIENCED A SIGNAL LOSS WITH THEIR DEXCOM CONTINUOUS GLUCOSE MONITORING (CGM) DEVICE, RESULTING IN NO GLUCOSE READINGS. UNAWARE OF HIS ACTUAL BLOOD GLUCOSE LEVELS DUE TO THE SIGNAL INTERRUPTION, THE PATIENT CONTINUED EATING AND ADMINISTERED 40 UNITS OF INSULIN. ON THE MORNING OF (B)(6) 2025, ONCE THE CGM SIGNAL WAS RESTORED, THE PATIENT USED A BG METER AND NOTICED A DISCREPANCY OF MORE THAN 20 MG/DL COMPARED TO THE CGM READINGS. EXACT VALUES COULD NOT BE CONFIRMED, AS THE PATIENT WAS UNAVAILABLE DURING THE REPORT AND THE CALLER DID NOT HAVE THE INFORMATION. LATER THAT DAY, THE PATIENT BEGAN EXPERIENCING SEVERE CRAMPING IN HIS LEGS AND ARMS, SUSPECTED TO BE DUE TO LACTIC ACID BUILDUP, AND COLLAPSED. EMERGENCY SERVICES WERE CALLED, AND UPON ARRIVAL AT THE HOSPITAL, THE PATIENT WAS ADMINISTERED FOUR IV SOLUTIONS TO STABILIZE HIS CONDITION. ATTEMPTS TO CONTACT THE PATIENT VIA PHONE AND EMAIL WERE UNSUCCESSFUL. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. IT HAS BEEN REPORTED THAT THERE WAS A DIFFERENCE IN READINGS OF MORE THAN 20 POINTS. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #240 - 3004753838-2025-230735 CRITICAL
View on MAUDE
Date of Event 2025-08-12
Patient Gender Female
Patient Age 59 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. E1: INITIAL REPORTER STATE: (B)(6). | IT WAS REPORTED THAT NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ACCORDING TO THE PATIENT¿S SPOUSE, ON (B)(6) 2025 AT AROUND 1:00 AM, THE PATIENT EXPERIENCED CONVULSIONS WHILE ASLEEP (MEANT TO BE SEIZURES). PRIOR TO SLEEPING, SHE HAD BEEN DOING FINE, AND HER CGM WAS DISPLAYING VALUES WITHIN HER NORMAL RANGE. WHILE ASLEEP, SHE WAS WOKEN UP BY AN ALARM FROM HER DEVICE INDICATING A BRIEF SENSOR ISSUE, WHICH LED HER HUSBAND TO SUSPECT THAT HER BLOOD GLUCOSE HAD DROPPED TO BELOW 2 MMOL/L. CONCERNED ABOUT HER SAFETY, HE IMMEDIATELY CALLED 911, AND PARAMEDICS ARRIVED AT APPROXIMATELY 2:15 AM. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL, WHERE SHE WAS ADMINISTERED IV FLUIDS, GLUCAGON, AND ANOTHER UNSPECIFIED INJECTION. HER BLOOD SUGAR WAS CLOSELY MONITORED, WITH INITIAL READINGS BETWEEN 2¿3 MMOL/L. FOLLOWING TREATMENT, HER GLUCOSE LEVELS ROSE TO APPROXIMATELY 5 MMOL/L. SHE REMAINED IN THE HOSPITAL FROM ABOUT 2:00 AM UNTIL 5:30 AM. AT THE SPOUSE¿S REQUEST, THE PATIENT WAS DISCHARGED TO CONTINUE RESTING AT HOME. DUE TO ONGOING WEAKNESS AND SHAKINESS, SHE REQUIRED THE USE OF A STROLLER FOR ASSISTANCE TO THE CAR. AT THE TIME OF THE REPORT THE PATIENT WAS FINE AND 90% RECOVERED. NO OTHER DETAILS WERE DOCUMENTED. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION AND PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #241 - 3004753838-2025-265409 CRITICAL
View on MAUDE
Date of Event 2025-08-11
Patient Gender Female
Patient Age 16 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON (B)(6) 2025, THE PEDIATRIC PATIENT¿S CGM RECEIVER BEGAN ALERTING WITH ESTIMATED GLUCOSE VALUES (EGV) BETWEEN 50¿65 MG/DL, SOMETIME AFTER THE SENSOR WAS PLACED ON THE ARM. NO FINGERSTICK BG TEST WAS PERFORMED AT THE TIME; INSTEAD, SUGAR WAS ADMINISTERED. THE PARENT BELIEVED THE PATIENT¿S ACTUAL BG LEVEL WAS LOWER THAN THE CGM INDICATED, AS THE PATIENT BEGAN EXPERIENCING SEIZURES. EMERGENCY SERVICES WERE CALLED, AND PARAMEDICS ARRIVED TO ASSIST. THE PARENT COULD NOT RECALL THE BG READINGS TAKEN BY PARAMEDICS OR ANY SPECIFIC TREATMENT ADMINISTERED DURING TRANSPORT. UPON ARRIVAL AT THE HOSPITAL, THE CGM RECEIVER CONTINUED TO DISPLAY EGVS BETWEEN 50¿65 MG/DL. ACCORDING TO THE PARENT, NO MEDICATIONS WERE ADMINISTERED BY MEDICAL PERSONNEL. THE PATIENT REMAINED HOSPITALIZED FOR TWO DAYS, WAS DISCHARGED, AND WAS REPORTEDLY FEELING FINE AT THE TIME OF FOLLOW-UP. THERE WAS NO DOCUMENTATION OF TREATMENT OR MANAGEMENT FOR HYPOGLYCEMIC SHOCK WITH SEIZURE IN THE RECORD. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINE. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4) DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND SEIZURE.
Report #242 - 3004753838-2025-238494 CRITICAL
View on MAUDE
Date of Event 2025-08-10
Patient Gender Male
Patient Age 33 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. | IT WAS REPORTED THAT NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT WAS NOT GETTING READINGS FROM THE CGM DUE TO A SENSOR ERROR. THE PATIENT HAD PAIN IN HIS LEGS, CHEST, IRREGULAR HEARTBEAT, EYE SIGHT WAS "DOWN" AND HE PASSED OUT. THE PATIENT'S AID WORKER CALLED AN AMBULANCE AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. THE PATIENT AS NOT TREATED WITH ANY MEDICATION WHILE IN THE AMBULANCE. AT THE HOSPITAL, VITALS WERE DONE AND A BG CHECKED AND IT WAS 580 MG/DL. THE PATIENT'S DOCTOR NOTED THAT THE PATIENT'S HEART BEAT PER MINUTE WAS IN A STATE OF A "HEART ATTACK" AND WAS ADVISED THAT THE PATIENT WAS IN DIABETIC KETOACIDOSIS (DKA). THE PATIENT WAS TREATED WITH UNSPECIFIED IV THERAPY AND AN INSULIN DRIP AND BLOOD THINNERS. THE PATIENT WAS DISCHARGED ON 08/13/2025. AT THE TIME OF THE REPORT, THE PATIENT FELT BETTER. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION AND PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #243 - 3004753838-2025-243111 CRITICAL
View on MAUDE
Date of Event 2025-08-07
Patient Gender Male
Patient Age 66 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT STATED THEY HAD A BG OF 700 MG/DL AND EXPERIENCED A SEIZURE. IT IS UNKNOWN WHAT THE CGM WAS DISPLAYING DURING THIS TIME. THE PATIENT'S WIFE TOOK THE PATIENT TO THE HOSPITAL AND WAS IN KETOACIDOSIS. THE PATIENT WAS TREATED WITH IV INSULIN. DUE TO HAVING A SEIZURE, THE PATIENT WAS ADVISED TO HAVE AN MRI AND TO GET CHECKED BY A NEUROLOGIST. THE PATIENT WAS IN THE HOSPITAL FOR 3 DAYS AND WAS GIVEN MEDICATION FOR "ANTI-SEIZURE". AT THE TIME OF THE REPORT, THE PATIENT WAS FEELING FINE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #244 - 3004753838-2025-232520 CRITICAL
View on MAUDE
Date of Event 2025-08-06
Patient Gender Female
Patient Age 12 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4) H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. | IT WAS REPORTED THAT AN UNSPECIFIED ALARM ISSUE WITH THE DEVICE OCCURRED. NO INFORMATION WAS PROVIDED ON SENSOR INSERTION DATE OR LOCATION. NO CGM OR BG VALUES WERE SPECIFIED. THE PEDIATRIC PATIENT HAD A SEIZURE AND ¿ENDED UP IN THE HOSPITAL.¿ ALTHOUGH REQUESTED, NO OTHER INFORMATION WAS PROVIDED. IT COULD NOT BE DETERMINED WITH INFORMATION PROVIDED THE DURATION OF THE HOSPITAL STAY. DATA HAS BEEN REQUESTED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #245 - 3004753838-2025-228155 CRITICAL
View on MAUDE
Date of Event 2025-08-05
Patient Gender Male
Patient Age 63 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT SENSOR FAILURE OCCURRED. THE SENSOR WAS INSERTED ON (B)(6) 2025. ON THE SAME DAY, IT WAS REPORTED THAT AT THE TIME OF THE CALL, THE PATIENT WAS NOT IN AN ACTIVE SENSOR SESSION AND WAS IN THE PROCESS OF STARTING A NEW ONE, THE REASON THE PATIENT WAS NOT IN AN ACTIVE SENSOR SESSION WAS DUE TO 2 FAILED SENSORS, WHICH OCCURRED ON THE SAME DAY. BASED ON THE LIMITED INFORMATION AVAILABLE, IT WAS ASSUMED THAT THE SEIZURE WAS CAUSED BY A DIABETIC EVENT. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED.
Report #246 - 3004753838-2025-229755 CRITICAL
View on MAUDE
Date of Event 2025-08-04
Patient Gender Female
Patient Age 26 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. H6: MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. | IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ACCORDING TO THE PATIENT, ON (B)(6) 2025, THE PATIENT¿S WEARABLE FAILED OVERNIGHT WHILE THE PATIENT WAS ASLEEP. UPON WAKING UP AROUND 6:45 AM, THE PATIENT HAD A SEIZURE. THE PATIENT¿S HUSBAND TREATED THE PATIENT WITH CRANBERRY JUICE AND AFTER A FEW MINUTES, THE PATIENT STABILIZED. AFTER SHE STABILIZED, HER BG METER READING WAS TAKEN AND FOUND TO BE 51 MG/DL. THE PATIENT DID NOT SEEK ASSISTANCE FROM A HIGHER LEVEL OF CARE. THE PATIENT WAS ¿FINE¿ AT THE TIME OF THE REPORT. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE PROBLEM COULD NOT BE CONFIRMED, AND PROBABLE CAUSE CANNOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Report #247 - 3004753838-2025-264173 CRITICAL
View on MAUDE
Date of Event 2025-08-02
Patient Gender N/A
Patient Age N/A
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). H6: MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED THAT AN UNSPECIFIED APP ISSUE OCCURRED. ON APPROXIMATELY ON (B)(6) 2025, AROUND 1:00 AM, THE SPOUSE CHECKED ON THE PATIENT AND NOTICED HE APPEARED CONFUSED AND DID NOT RECOGNIZE HER. SHE IMMEDIATELY CALLED EMERGENCY SERVICES (EMT), WHO ARRIVED AROUND 1:10 AM. UPON ARRIVAL, EMT CHECKED THE PATIENT¿S BLOOD GLUCOSE (BG) LEVEL, WHICH WAS 31 MG/DL. THEY ADMINISTERED TREATMENT TO RAISE HIS BLOOD SUGAR, AND THE SPOUSE ALSO GAVE HIM ORANGE JUICE. THE PATIENT WAS THEN TRANSPORTED TO THE EMERGENCY ROOM (ER), WHERE HE REMAINED FOR APPROXIMATELY 5-6 HOURS. THE SPOUSE MENTIONED SHE WAS UNFAMILIAR WITH HOW TO CHECK THE APP AND DECLINED TO PROVIDE FURTHER DETAILS ABOUT THE EVENT, STATING SHE WAS HAVING DIFFICULTY RECALLING SPECIFICS FROM OVER A MONTH AGO. DURING THE FOLLOW-UP CALL ON (B)(6) 2025, IT WAS NOTED THAT THE PATIENT IS CURRENTLY RECOVERING AND UNDERGOING THERAPY FOR A STROKE. DATA HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #248 - 3004753838-2025-230337 CRITICAL
View on MAUDE
Date of Event 2025-08-02
Patient Gender Male
Patient Age 21 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM, WHICH IS OFF-LABEL USAGE OF THE DEVICE ON (B)(6) 2025. ON THE NIGHT OF (B)(6) 2025, THE PATIENT HAD "INSULIN LOW" THAT REQUIRED AN AMBULANCE TO THE EMERGENCY ROOM. THE PATIENT HAD A SEIZURE. THE DOCTOR AT THE HOSPITAL STATED THAT THE CGM WAS OFF FROM THE MANUAL BLOOD SUGAR TEST. DURING THE EVENT, THE PATIENT WAS WITH FRIENDS. THE CGM WAS SHOWING A RAPID DROP BUT THE PATIENT STATED HE HAD BEEN HIGH BEFORE SO HE WASN'T CONCERNED BUT THE DEVICE DID NOT PROVIDE AN ALERT OR PERHAPS HE DID NOT HEAR IT UNTIL AN AMBULANCE WAS CALLED. HE WAS REPORTEDLY REALLY LOW BUT WAS ABLE TO TALK. PRIOR TO AMBULANCE ARRIVING THE PATIENT WAS GIVEN INTRANASAL GLUCAGON. AMBULANCE ARRIVED BEFORE 9:00PM AND THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM. AT THE ER, THE CGM WAS 130 MG/DL WHILE THE BG WAS 59 MG/DL. THE PATIENT WAS TREATED WITH D50 AND AFTER 5 HOURS, THE PATIENT RECOVERED. AFTER THE PATIENT RECOVERED, THEY WANTED TO KEEP THE PATIENT FOR OBSERVATION. AT THAT TIME, THE INSULIN PUMP WAS REMOVED. THE PATIENT WAS RELEASED THE FOLLOWING DAY AT 3:00AM. PRIOR TO DISCHARGE, THE PATIENT'S BG WAS 233 MG/DL AND THE CGM WAS 280 MG/DL. AT THE TIME OF THE REPORT, THE PATIENT WAS DOING OKAY. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR WHEN THE PATIENT HAD A SEIZURE. UPON ARRIVAL AT THE EMERGENCY ROOM, THE PATIENT'S BLOOD GLUCOSE WAS CHECKED AND IT WAS REPORTED TO FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID AND A ZONE AT THE TIME OF DISCHARGE. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #249 - 3004753838-2025-229977 CRITICAL
View on MAUDE
Date of Event 2025-08-01
Patient Gender Male
Patient Age 38 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND SEIZURE. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT EXPERIENCED A SEIZURE ON THE SAME DAY A SENSOR WAS APPLIED TO THE ARM. DURING THE EPISODE, THE PATIENT BIT HIS TONGUE AND LOST CONSCIOUSNESS. EMERGENCY MEDICAL SERVICES WERE CALLED, AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL VIA AMBULANCE. UPON ARRIVAL, THE PATIENT WAS ADMINISTERED SUGAR AND IV GLUCOSE. HE WAS DISCHARGED LATER THAT SAME DAY. AT AN UNSPECIFIED TIME DURING THE INCIDENT, THE CGM WAS RECORDED AT 88 MG/DL, WHILE THE BLOOD GLUCOSE LEVEL WAS MEASURED AT 40 MG/DL. AT THE TIME OF THIS REPORT, THE PATIENT IS STABLE AND IN RECOVERY. ALTHOUGH ADDITIONAL ATTEMPTS WERE MADE TO OBTAIN CLARIFICATION OF EVENT DETAILS, NO REPLY HAS BEEN RECEIVED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALLS WITHIN THE B ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #250 - 3004753838-2025-230093 CRITICAL
View on MAUDE
Date of Event 2025-07-29
Patient Gender Male
Patient Age 47 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
B5 DESCRIBE EVENT OR PROBLEM - ADDITIONAL H2 CORRECTION/ADDITIONAL INFORMATION H6 INVESTIGATION FINDINGS - CORRECTION H6 INVESTIGATION CONCLUSION - CORRECTION | SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION BECAME AVAILABLE. IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT WAS HAVING FALSE READINGS BUT HE CANNOT REMEMBER THE VALUES ON HIS CGM RECEIVER AND BG METER THE DAY AFTER THE SENSOR WAS PUT ON THE ARM. HE WENT ON A SEIZURE AND WAS CONVULSING ON THE FLOOR AROUND 10AM SO HIS MOM CALLED THE PARAMEDICS. HE WAS HOOKED UP ON IVS AND HIS BLOOD GLUCOSE WAS MONITORED UNTIL IT WENT UP TO OVER 100 MGDL BEFORE THE PARAMEDICS LEFT AND HE WAS FEELING OKAY. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT WAS HAVING FALSE READINGS BUT HE CANNOT REMEMBER THE VALUES ON HIS CGM RECEIVER AND BG METER THE DAY AFTER THE SENSOR WAS PUT ON THE ARM. HE WENT ON A SEIZURE AND WAS CONVULSING ON THE FLOOR AROUND 10AM SO HIS MOM CALLED THE PARAMEDICS. HE WAS HOOKED UP ON IVS AND HIS BLOOD GLUCOSE WAS MONITORED UNTIL IT WENT UP TO OVER 100 MGDL BEFORE THE PARAMEDICS LEFT AND HE WAS FEELING OKAY. DATA HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.
Report #251 - 3004753838-2025-235515 CRITICAL
View on MAUDE
Date of Event 2025-07-26
Patient Gender Female
Patient Age 57 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN UNSPECIFIED MALFUNCTION OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON APPROXIMATELY (B)(6) 2025, THE PATIENT HAD BEEN WORKING IN HER YARD AND CAME INSIDE DUE TO THE EXTREME HEAT. SHORTLY AFTER, THE PATIENT FELT DIZZY, DISORIENTED, AND HAD ¿MENTAL FOG¿. HER DEXCOM CGM VALUE ON HER TANDEM MOBI INSULIN PUMP WAS HIGH MG/DL. THE PATIENT HAD NO BG METER TESTS, THEREFORE, COULD NOT TAKE A BG METER COMPARISON VALUE. THE PATIENT DROVE HERSELF TO THE EMERGENCY ROOM (ER). THE PATIENT HAD UNSPECIFIED TESTS AND LAB WORK DONE. HEAT STROKE WAS RULED OUT. THE PATIENT COULD NOT RECALL HER BG METER READING AT THE ER, BUT HER CGM WAS CONTINUING TO READ HIGH MG/DL. THE PATIENT WAS TREATED WITH IV FLUIDS AND WAS DISCHARGED 3-4 HOURS LATER. ON (B)(6) 2025, THE PATIENT WENT TO A SCHEDULED APPOINTMENT WITH HER ENDOCRINOLOGIST AND DISCUSSED THE EVENT THAT OCCURRED ON 07/26/2025. THE PATIENT¿S DOCTOR TOLD THE PATIENT SHE MAY HAVE EXPERIENCED AN ¿INSULIN OVERDOSE¿ IF THE CGM CONTINUED TO READ HIGH MG/DL CONSISTENTLY. THEREFORE, THE PATIENT FELT HER CGM DEVICE MALFUNCTIONED. AS A RESULT, THE PATIENT WAS ADVISED TO OBTAIN A BG METER TO USE FOR COMPARISON TESTING. AT THE TIME OF REPORT, THE PATIENT STILL FELT UNWELL AND HAD EXPERIENCED SOME HAIR LOSS BUT WAS FEELING BETTER COMPARED TO BEFORE. DATA HAS BEEN REQUESTED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4) DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. H6 HEALTH EFFECT - CLINICAL CODE - E2318 HAIR LOSS H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED.
Report #252 - 3004753838-2025-232092 CRITICAL
View on MAUDE
Date of Event 2025-07-24
Patient Gender Male
Patient Age 59 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT'S CGM KEPT ALERTING HIM THAT HE WAS LOW AND THE READING WAS AROUND 50 MG/DL. HE DIDN'T FEEL ANY SYMPTOMS SO HE ATE BASED OFF OF THE CGM READING AND SLEPT. HE DID NOT HAVE A GLUCOMETER TO CHECK FOR COMPARISON. LATER THAT DAY A FRIEND CALLED HIM AND HE STATED HE WAS FEELING SYMPTOMS THE FOLLOWING SYMPTOMS, BLURRY VISION, THIRSTY, DRY MOUTH, TIREDNESS, DIFFICULTY SPEAKING AND CONFUSION. HE STATED THAT HIS FRIEND WASN'T ABLE TO UNDERSTAND HIM PROPERLY AND THINKS THAT HE WAS HAVING A STROKE, SO HIS FRIEND CALLED 911. HE COULD NOT REMEMBER THE CGM READING DURING THAT TIME BUT STATED IT WAS STILL SHOWING A LOW VALUE. PARAMEDICS ARRIVED AROUND 04:30PM. THEY CHECKED HIS VITALS AND THEY DID A FINGERSTICK AND THE READING WAS 560 MG/DL WHILE THE CGM WAS STILL READING 50 MG/DL. HE DOES NOT KNOW IF THE PARAMEDICS GAVE HIM MEDICATIONS BUT THEY TRANSPORTED HIM TO THE EMERGENCY ROOM. AT THE ER, THEY STARTED AN IV AND WAS PROBABLY GIVEN MEDICATIONS BUT THE PATIENT WAS NOT SURE. LATER THAT DAY HE WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) AND STAYED AT THE HOSPITAL UNTIL (B)(6) 2025 WHEN HE WAS DISCHARGED. AT THE TIME OF THE REPORT, THE PATIENT WAS DOING FINE. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR DURING THE TIME THE PATIENT HAD SYMPTOMS. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID AT THE ER. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #253 - 3004753838-2025-235947 CRITICAL
View on MAUDE
Date of Event 2025-07-23
Patient Gender Female
Patient Age 65 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4).VOLUNTARY MDR/MEDWATCH REPORT NUMBER MW5173215DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | A VOLUNTARY MDR/MEDWATCH REPORT WAS RECEIVED ON 08/11/2025. IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE DATE OF EVENT IS AN APPROXIMATION. ACCORDING TO A REPORT RECEIVED VIA MAUDE, THE REPORTER INDICATED THAT THE DEXCOM G6 DEVICE PROVIDED INACCURATE BLOOD GLUCOSE READINGS. SPECIFICALLY, THE DEVICE DISPLAYED A NORMAL GLUCOSE LEVEL WHILE A FINGERSTICK TEST SHOWED A LOW BLOOD SUGAR LEVEL OF 40 MG/DL. AS A RESULT OF RELYING ON THE INCORRECT DEVICE READING, THE INDIVIDUAL EXPERIENCED A DIABETIC STROKE AFFECTING THE LEFT SIDE. DUE DILIGENCE WAS NOT ATTEMPTED AS THE REPORTER'S DETAILS WERE NOT ABLE TO BE IDENTIFIED. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #254 - 3004753838-2025-245523 CRITICAL
View on MAUDE
Date of Event 2025-07-20
Patient Gender N/A
Patient Age N/A
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ACCORDING TO THE PATIENT, ON APPROXIMATELY 07/20/2025, HIS BG WAS VERY HIGH THAT IT CAUSED A SEIZURE. THE PATIENT CAN NO LONGER RECALL THE EXACT VALUES BUT NOTED THAT THE CGM OFTEN SHOWED 100 MG/DL WHILE FINGERSTICK SHOWED BETWEEN 400-500 MG/DL. HE ATTEMPTED TO CALIBRATE THE DEVICE, BUT IT WOULD NOT ACCEPT THE CALIBRATION AND DISPLAYED CALIBRATION NOT USED. THE PATIENT SAID THAT THE SEIZURE OCCURRED BEFORE LUNCH. HIS FRIEND FOUND HIM FLAT, FACE DOWN ON THE TABLE AND ASSUMED IT WAS DUE TO HIS BLOOD SUGAR. THE PATIENT REPORTED THAT HE DIDN'T RECEIVE ANY MEDICATION FOR HYPERGLYCEMIA WITH SEIZURES AND CONFIRMED THAT HE DID NOT PASS OUT DURING THE SEIZURES. THE PATIENT DID NOT GO TO A HEALTHCARE FACILITY BUT IS CURRENTLY BEING EVALUATED BY A DOCTOR. DATA WAS EVALUATED, AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #255 - MW5175237 CRITICAL
View on MAUDE
Date of Event 2025-07-16
Patient Gender Male
Patient Age 52 YR
Device DEXCOM G7 (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
DEXCOM G7 HAVE BEEN VERY INACCURATE AND LOSING CONNECTION WITH IPHONE APP AND BETA BIONICS ILET PUMP. CAUSED MY SUGARS TO BE VERY HIGH FOR AN EXTENDED PERIOD OF TIME AND HAVE A FAINTING SPELL OR SEIZURE FROM IT. COMPANY HAS REPLACED MANY SENSORS WITH SENSORS THAT HAVE FAILED OR GIVEN INACCURATE RESULTS IMMEDIATELY. STILL BEING EVALUATED BY PROFESSIONALS FOR ISSUES.
Report #256 - 3004753838-2025-266886 CRITICAL
View on MAUDE
Date of Event 2025-07-15
Patient Gender Female
Patient Age 16 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON (B)(6) 2025, THE PEDIATRIC PATIENT'S RECEIVER BEGAN BEEPING, INDICATING A LOW ESTIMATED GLUCOSE VALUE (EGV) SHORTLY AFTER THE SENSOR WAS APPLIED TO THE ARM. THE PARENT DID NOT PERFORM A FINGERSTICK BLOOD GLUCOSE TEST BUT ADMINISTERED SUGAR BASED ON THE RECEIVER'S ALERT. THE PARENT BELIEVES THE PATIENT'S ACTUAL GLUCOSE LEVEL WAS LOWER THAN WHAT THE RECEIVER INDICATED, AS THE PATIENT BEGAN EXPERIENCING SEIZURES. EMERGENCY SERVICES WERE CONTACTED, AND THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM. ACCORDING TO THE PARENT, NO MEDICATIONS WERE ADMINISTERED DURING THE HOSPITAL VISIT. THE PATIENT REMAINED HOSPITALIZED FOR TWO DAYS AND WAS DISCHARGED IN STABLE CONDITION. THE PARENT REPORTS THE PATIENT IS CURRENTLY FEELING WELL. IT IS IMPORTANT TO NOTE THAT DOCUMENTATION REGARDING THE TREATMENT AND MANAGEMENT OF HYPOGLYCEMIC SHOCK WITH SEIZURE WAS NOT INCLUDED IN THE MEDICAL RECORD. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND SEIZURE. PLEASE DISREGARD H6 HEALTH EFFECT CLINICAL CODE - 4582 NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AS THIS CODES ARE NOT APPLICABLE FOR THIS REPORT.
Report #257 - 3004753838-2025-228294 CRITICAL
View on MAUDE
Date of Event 2025-07-15
Patient Gender Male
Patient Age 47 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON APPROXIMATELY (B)(6) 2025, THE PATIENT REPORTED GETTING FALSE READINGS ON THE RECEIVER. THE RECEIVER WAS SHOWING A READING OVER 200 MG/DL AND WHILE WALKING INTO A ROOM AT HOME, HE SUDDENLY BLACKED OUT AND WENT INTO A SEIZURE. THIS RESULTED IN A BROKEN NOTES AND RIBS. THE PATIENT STATED THEY EVENTUALLY CAME OUT OF THE SEIZURE AND DID NOT CALL FOR MEDICAL ATTENTION. AT THE TIME OF THE REPORT, THE PATIENT WAS DOING OKAY. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR WHEN THE PATIENT HAD SEIZURE. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #258 - 3004753838-2025-249737 CRITICAL
View on MAUDE
Date of Event 2025-07-09
Patient Gender N/A
Patient Age N/A
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED THAT AN UNSPECIFIED MALFUNCTION/ISSUE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN SENSOR ISSUE. AT AROUND 1130PM, THE PATIENT¿S CGM ALERTED HIM TO A VALUE OF 44 MG/DL. THE PATIENT WAS WEARING A TANDEM INSULIN PUMP. THE PATIENT SELF-TREATED WITH 40 GRAMS OF CARBOHYDRATES IN COOKIES AND MILK. THE PATIENT THEN RETURNED TO BED. THE PATIENT STATED HIS CGM CONTINUED TO ALERT HIM TO A LOW READING AND THEN ¿MALFUNCTIONED¿. NO OTHER SPECIFIC DETAILS WERE REPORTED REGARDING WHAT THIS MALFUNCTION WAS OR HOW THE CGM WAS BEHAVING. AT AN UNSPECIFIED TIME LATER, THE PATIENT HAD A GRAND MAL SEIZURE. HE WAS MAKING LOUD NOISES AND HAD URINATED ON HIMSELF. HIS DAUGHTER HEARD THE NOISE AND CHECKED ON HIM, HOWEVER, HE COULDN¿T RECOGNIZE HIMSELF OR HIS DAUGHTER INITIALLY. THE PATIENT¿S BG METER READING WAS 20 MG/DL WHILE IT WAS REPORTED THAT THE CGM ¿STOPPED WORKING¿. THE PATIENT¿S DAUGHTER DISCONNECTED THE PATIENT¿S TANDEM INSULIN PUMP. THE SEIZURE LASTED 20-30 MINUTES AND THE PATIENT¿S DAUGHTER KEPT HIM LAYING DOWN TO PREVENT ANY INJURY. ONCE ABLE TO COMMUNICATE, THE PATIENT DID NOT WAIT TO CALL EMERGENCY MEDICAL SERVICES (EMS), AS HE STATED HE ALREADY TREATED HIMSELF WITH FOOD AND DRINK EARLIER AND PREFERRED TO WAIT FOR HIS BG TO RISE FROM THAT. THE PATIENT EVENTUALLY FELL BACK TO SLEEP. NO ASSISTANCE WAS PROVIDED FROM A HIGHER LEVEL OF CARE. WHEN THE PATIENT WOKE UP, THE PATIENT¿S CGM WAS ¿WORKING AGAIN¿ HOWEVER, IT WAS ¿100 POINTS OFF¿ FROM HIS BG METER READING. THE PATIENT THEN REMOVED THE SENSOR. THE PATIENT WAS ¿FINE¿ AT THE TIME OF REPORT. DATA HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #259 - 3004753838-2025-265440 CRITICAL
View on MAUDE
Date of Event 2025-06-17
Patient Gender Female
Patient Age 15 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND SEIZURE. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON (B)(6) 2025, THE PEDIATRIC PATIENT¿S CGM RECEIVER BEGAN ALERTING FOR LOW ESTIMATED GLUCOSE VALUES (EGV) SOMETIME AFTER THE SENSOR WAS PLACED ON THE ARM. NO FINGERSTICK BG TEST WAS PERFORMED; INSTEAD, SUGAR WAS ADMINISTERED. THE PARENT BELIEVED THE PATIENT¿S ACTUAL BG LEVEL WAS LOWER THAN THE CGM INDICATED, AS THE PATIENT BEGAN EXPERIENCING SEIZURES. EMERGENCY SERVICES WERE CALLED, AND THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM (ER). ACCORDING TO THE PARENT, NO MEDICATIONS WERE ADMINISTERED DURING THE HOSPITAL STAY. THE PATIENT REMAINED HOSPITALIZED FOR TWO DAYS, WAS DISCHARGED, AND WAS REPORTEDLY FEELING FINE AT THE TIME OF FOLLOW-UP. THERE WAS NO DOCUMENTATION OF TREATMENT OR MANAGEMENT FOR HYPOGLYCEMIC SHOCK WITH SEIZURE IN THE RECORD. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #260 - MW5175907 CRITICAL
View on MAUDE
Date of Event 2025-06-17
Patient Gender Unknown
Patient Age NA
Device DEXCOM G7 SENSOR (INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
I AM A TYPE 1 DIABETIC AND HAVE BEEN A USER OF YOUR DEXCOM G7 SINCE (B)(6) 2023. PRIOR TO THAT TIME, I RELIED ON A LIBRAVIEW SENSOR BUT SWITCHED ON A RECOMMENDATION FROM MY DOCTOR. FROM TIME-TO-TIME, I HAVE HAD SOME PROBLEMS WITH THE DEXCOM G7 SENSOR: "FAILURE TO PAIR'', "BRIEF SENSOR ISSUE", AND DISCREPANCIES BETWEEN SENSOR READINGS AND A FINGER STICK VALUE. I REPORTED THESE TO YOUR CUSTOMER SERVICE PEOPLE AND USUALLY RECEIVED REPLACEMENT SENSORS. HOWEVER, RECENTLY I HAVE HAD THREE SERIOUS INCIDENTS THAT HAVE DESTROYED MY TRUST IN THE RELIABILITY OF THE G7 SENSORS. THE MOST SERIOUS INCIDENT OCCURRED ON (B)(6) THIS YEAR. THE G7 SENSOR ALERTED ME TO A LOW VALUE OF 75 MG/DI. I STARTED TO INGEST CARBS, BUT THE VALUE REPORTED BY G7 DID NOT MOVE UP THE WAY I WOULD HAVE EXPECTED. WHEN I USED A "FINGER STICK' TO CROSS CHECK, THE VALUE WAS ACTUALLY 55, 20 POINTS LOWER. A FEW MINUTES LATER, I WENT INTO CONVULSIONS AND MY WIFE HAD TO CALL THE (B)(6) EMS. I WAS TAKEN TO (B)(6) HOSPITAL AND SPENT OVERNIGHT THERE. THE SECOND INCIDENT OCCURRED ABOUT TWO WEEKS AFTER I TRIED USING AN INSULIN PUMP WITH A G7 AS THE SENSOR. FOR UNKNOWN REASONS, WITH NO ALERT FROM THE SENSOR, I WOKE UP ABOUT 1 AM. I WAS SUSPICIOUS AND TOOK A "FINGER STICK" READING. IT WAS 68. NOT KNOWING WHAT THE PUMP WAS DOING (FEEDING ME INSULIN??), I DISCONNECTED THE PUMP AND STOPPED USING IT BECAUSE I COULD NOT TRUST THE SENSOR INPUT. THEN, YESTERDAY, SUNDAY, (B)(6), I HAD A SERIOUS OF READINGS ABOVE 350 AND TRENDING HIGHER. THE G7 KEPT RISING, PEAKING SOMEWHERE ABOVE 619, WHICH WAS ABSURD! THE "FINGER STICK" VALUE WAS IN THE LOW 300'S. WHEN I TRIED TO ENTER THE DATA INTO THE G7 TO "CALIBRATE " THE DEVICE, IT REFUSED THE ENTRY. A HIGH READING FROM THE SENSOR INVALIDATES THE "LOW ALERT" FUNCTION OF THE SENSOR! I HAVE 8 SENSORS ON HAND INCLUDING THE ONE I'M WEARING. I INTEND TO SWITCH TO LIBRAVIEW AS SOON I CAN GET AN RX AND INSURANCE PERMISSION TO MAKE THE SWITCH. I AM SENDING A COPY OF THIS LETTER TO THE FDA TO ALERT THEM TO WHAT I CONSIDER A SERIOUS SAFETY PROBLEM. DEVICE CODES: 1535, 3283, 2339, 2890, 1506. PATIENT CODES: 4406, 1912. REFERENCE REPORTS MW5175908, MW5175909.
Report #261 - 3004753838-2025-265429 CRITICAL
View on MAUDE
Date of Event 2025-06-10
Patient Gender Female
Patient Age 15 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND SEIZURE. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON (B)(6) 2025, THE PEDIATRIC PATIENT¿S CGM RECEIVER BEGAN ALERTING FOR LOW ESTIMATED GLUCOSE VALUES (EGV) SOMETIME AFTER THE SENSOR WAS PLACED ON THE ARM. NO FINGERSTICK BG TEST WAS PERFORMED AT THE TIME; INSTEAD, SUGAR WAS ADMINISTERED. THE PARENT BELIEVED THE PATIENT¿S ACTUAL BG LEVEL WAS LOWER THAN THE CGM INDICATED, AS THE PATIENT BEGAN EXPERIENCING SEIZURES. EMERGENCY SERVICES WERE CALLED, AND THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM (ER). ACCORDING TO THE PARENT, NO MEDICATIONS WERE ADMINISTERED BY MEDICAL PERSONNEL DURING THE HOSPITAL STAY. THE PATIENT REMAINED HOSPITALIZED FOR TWO DAYS, WAS DISCHARGED, AND WAS REPORTEDLY FEELING FINE AT THE TIME OF FOLLOW-UP. THERE WAS NO DOCUMENTATION OF TREATMENT OR MANAGEMENT FOR HYPOGLYCEMIC SHOCK WITH SEIZURE IN THE RECORD. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #262 - 3004753838-2025-238991 CRITICAL
View on MAUDE
Date of Event 2025-04-29
Patient Gender Female
Patient Age 74 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. THE DATE OF THE EVENT IS AN APPROXIMATION. ON (B)(6) 2025, THE PATIENT EXPERIENCED SYMPTOMS INCLUDING WEAKNESS, VOMITING, AND COGNITIVE DECLINE. SHE WAS TRANSPORTED TO THE HOSPITAL, WHERE AN INITIAL FINGERSTICK TEST SHOWED A CGM READING OF "LOW" WHILE THE BLOOD GLUCOSE LEVEL WAS 100 MG/DL. WITHIN 30 MINUTES, HER BLOOD GLUCOSE DROPPED TO 38 MG/DL, PROMPTING TREATMENT WITH INTRAVENOUS FLUIDS. DURING HER HOSPITAL STAY, THE PATIENT DEVELOPED DIARRHEA AND WAS TREATED WITH THE ANTIBIOTIC CIPROFLOXACIN (CIPRO). A CT SCAN WAS PERFORMED TO RULE OUT A STROKE. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR THREE DAYS. NO FURTHER DOCUMENTATION OF MEDICAL EVALUATION OR INTERVENTION WAS PROVIDED. ACCORDING TO THE PATIENT, SHE HAD EXPERIENCED ISSUES WITH TWO SENSORS PRIOR TO THE EVENT DUE TO THE INACCURACY. THESE INACCURACIES ALLEGEDLY LED TO SEVERAL DAYS OF HYPOGLYCEMIA, AS THE INSULIN PUMP ADMINISTERED INSULIN BASED ON THE HIGH READINGS. IT IS SUSPECTED THAT THE SYMPTOMS EXPERIENCED ON (B)(6) 2025 MAY HAVE BEEN DUE TO EXCESSIVE INSULIN ADMINISTRATION RESULTING FROM THE FAULTY SENSOR DATA. AT THE TIME OF THE REPORT, THE PATIENT WAS STABLE. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID WHEN THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4) DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.
Report #263 - 3004753838-2025-245518 CRITICAL
View on MAUDE
Date of Event 2025-04-18
Patient Gender Male
Patient Age 65 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. THE DATE OF EVENT IS AN APPROXIMATION. ON (B)(6) 2025, THE PATIENT REPORTED A BLOOD GLUCOSE (BG) LEVEL REACHING APPROXIMATELY 1600 MG/DL. IT WAS NOT INITIALLY SPECIFIED WHETHER THIS READING WAS FROM A BLOOD GLUCOSE METER OR CONTINUOUS GLUCOSE MONITOR (CGM), BUT IT WAS LATER CLARIFIED TO BE FROM A BG METER. WHILE IN HIS FRONT YARD, THE PATIENT LOST CONSCIOUSNESS. UPON REGAINING CONSCIOUSNESS, HE MANAGED TO WALK INTO HIS HOME, UNDRESSED, AND SUBSEQUENTLY COLLAPSED ON THE CARPET. HIS FAMILY HAD BEEN ATTEMPTING TO LOCATE HIM, AND HIS WIFE DISCOVERED HE HAD NOT GONE TO WORK. SHE CONTACTED EMERGENCY SERVICES, AND PARAMEDICS WERE DISPATCHED TO THE RESIDENCE. UPON ARRIVAL, PARAMEDICS FOUND THE PATIENT AND INDICATED THAT HE LIKELY WOULD NOT HAVE SURVIVED HAD THEY ARRIVED 30 MINUTES LATER. NOTABLY, CGM READINGS THROUGHOUT THE DAY HAD CONSISTENTLY SHOWN HYPOGLYCEMIA, WITH VALUES AROUND 40 MG/DL. THE PATIENT REPORTED RECEIVING TREATMENT WITH WHAT HE DESCRIBED AS ¿B10 SUGAR WATER¿ OR A SMALL PACKET HE BELIEVED TO BE B10. THERE IS NO AVAILABLE INFORMATION EXPLAINING WHY GLUCOSE WAS ADMINISTERED DURING A STATE OF SEVERE HYPERGLYCEMIA. AT THE TIME OF THE REPORT, THE PATIENT WAS STABLE AND FEELING FINE, WITH A BG READING OF 216 MG/DL. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4).
Report #264 - 3004753838-2025-272097 CRITICAL
View on MAUDE
Date of Event 2024-11-15
Patient Gender Female
Patient Age 60 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). | IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. ON APPROXIMATELY (B)(6) 2024, THE PATIENT STATED THE CGM DID NOT GIVE AN ALARM WHEN SHE WAS LOW. SHE COULD NOT RECALL WHAT HER BLOOD GLUCOSE READING WAS. SHE RECALLED SCREAMING AND BEGAN SEIZING. PEOPLE THAT WERE WORKING ON HER HOUSE CALLED THE PATIENT'S DAUGHTER. WHEN THE DAUGHTER ARRIVED, THE PATIENT WAS STILL SEIZING, HER JAW WAS CLENCHED AND THEN PASSED OUT. THE DAUGHTER CALLED 911. PARAMEDICS CHECKED A BG READING AND IT WAS VERY LOW (NO SPECIFIC VALUE PROVIDED) AND IT WAS NOT KNOWN WHAT THE CGM WAS DISPLAYING DURING THAT TIME. THE PATIENT WAS TREATED WITH IV GLUCOSE AND REGAINED CONSCIOUSNESS. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. A BG WAS CHECKED AT THE HOSPITAL AND IT WAS STILL LOW. THE PATIENT STATED THAT THEY PROBABLY ADMINISTERED MORE IV GLUCOSE. AFTER 2 HOURS, THE PATIENT WAS DISCHARGED. AT THE TIME OF THE REPORT, THE PATIENT WAS FEELING GOOD. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION AND PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.
Report #265 - 3004753838-2025-267601 SEVERE
View on MAUDE
Date of Event 2025-09-09
Patient Gender Female
Patient Age 87 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM. ON (B)(6) 2025 AROUND 01:55, THE PATIENT WAS VOMITING, FEELING TIRED, CONFUSED, LETHARGIC AND WEAK. THE PATIENT'S DAUGHTER SAID THAT THE CGM WAS 270 MG/DL. THE PATIENT'S CONFUSION WORSENED SO THE DAUGHTER CALLED 911 AND PARAMEDICS ARRIVED AROUND 02:00 AM. THE DAUGHTER DID NOT ADMINISTER ANY MEDICATION PRIOR TO CALLING THE 911. THE DAUGHTER WAS NOT SURE IF THEY TOOK MANUAL BG. IN THE AMBULANCE, THE PATIENT WAS TREATED WITH IV FLUID AND THE PATIENT WAS TAKEN TO THE HOSPITAL. THE DAUGHTER FOLLOWED AND ARRIVED AT THE HOSPITAL AROUND 02:45 AM. WHEN SHE ARRIVED. SHE WAS INFORMED THAT THE BG TAKEN AT THE HOSPITAL WAS 907 MG/DL AND WAS NOT INFORMED IF CGM WAS CHECKED TO COMPARE THE READINGS. DURING THIS TIME, IV FLUID AND INSULIN IV WAS ALREADY ADMINISTERED TO THE PATIENT. THE PATIENT STAYED IN THE EMERGENCY ROOM UNTIL 11:00 AM AND THEN MOVED TO THE INTENSIVE CARE UNIT (ICU). ADDITIONAL MEDICATION WAS PROVIDED: ANTIBIOTIC AND POTASSIUM. THE PATIENT WAS STILL EXTREMELY CONFUSED DURING THIS TIME. THE PATIENT WAS MOVED TO THE CRITICAL CARE UNIT APPROXIMATELY IN THE MORNING ON (B)(6) 2025. THE PATIENT WAS RECOVERING AND STILL IN THE HOSPITAL AT THE TIME OF THE REPORT. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #266 - 3004753838-2025-273025 SEVERE
View on MAUDE
Date of Event 2025-09-03
Patient Gender Female
Patient Age 37 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED VOMITING, FREQUENT URINATION, AND EXTREME THIRST. THE CGM WAS READING 40 MG/DL, AND THE BLOOD GLUCOSE WAS NOT CHECKED. THE PATIENT SELF-TREATED WITH JUICE. THE PARENT CALLED AN AMBULANCE AFTER NOT HEARING FROM HER. SHE WAS BARELY CONSCIOUS WHEN SHE WAS TAKEN TO THE EMERGENCY ROOM AND ONLY REALIZED HER BLOOD SUGAR WAS HIGH AFTER WAKING UP IN THE HOSPITAL. MEDICAL INTERVENTION INCLUDED INTRAVENOUS THERAPY AND ELECTROLYTE STABILIZATION. SHE REMAINED HOSPITALIZED FOR FOUR DAYS¿TWO IN THE INTENSIVE CARE UNIT AND TWO IN A REGULAR MEDICAL UNIT. THE PATIENT DID NOT SPECIFY WHETHER THE IV THERAPY WAS ADMINISTERED IN THE EMERGENCY ROOM (ER) OR IN THE INTENSIVE CARE UNIT (ICU). THE PATIENT STATED THAT SHE IS CURRENTLY OKAY. NO OTHER DETAILS WERE DOCUMENTED. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR WHEN THE PATIENT HAD SYMPTOMS. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA.
Report #267 - 3004753838-2025-275313 SEVERE
View on MAUDE
Date of Event 2025-08-27
Patient Gender Female
Patient Age 53 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT EXPERIENCED VOMITING, DIZZINESS, AND BLURRED VISION TWO DAYS AFTER APPLYING THE SENSOR TO HER ARM. SHE USES THE OMNIPOD 5 (OP5) SYSTEM IN A MODIFIED CLOSED-LOOP CONFIGURATION. AT THE TIME OF THE EPISODE, HER ESTIMATED GLUCOSE VALUE (EGV) WAS REPORTED AS ¿LOW¿ ON BOTH HER APP AND PUMP, WHILE HER ACTUAL BG WAS ELEVATED, THOUGH THE EXACT VALUE WAS NOT RECALLED. DESPITE SYMPTOMATIC HYPERGLYCEMIA, THE PATIENT CONSUMED ORANGE JUICE IN AN ATTEMPT TO TREAT WHAT APPEARED TO BE HYPOGLYCEMIA BASED ON CGM READINGS. FOLLOWING THIS, THE EGV CONTINUED TO DISPLAY ¿LOW¿ ON BOTH THE APP AND PUMP. DUE TO WORSENING SYMPTOMS, HER SPOUSE TRANSPORTED HER TO THE EMERGENCY DEPARTMENT (ED), WHERE HER BG WAS MEASURED AT OVER 1200 MG/DL, WHILE HER CGM CONTINUED TO REPORT ¿LOW.¿ SHE WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA) AND ADMITTED TO THE INTENSIVE CARE UNIT (ICU). TREATMENT INCLUDED AN INSULIN INFUSION AND IV FLUIDS. THE PATIENT REMAINED HOSPITALIZED UNTIL (B)(6) 2025, AFTER WHICH SHE WAS STABILIZED AND DISCHARGED. DURING THE FOLLOW-UP CALL, THE PATIENT REPORTED BEING IN GOOD CONDITION, THOUGH STILL IN RECOVERY. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR WHEN THE PATIENT WAS IN THE ICU BUT EACH READING SHOWED A GRADUAL DECREASE IN GLUCOSE LEVELS, DROPPING APPROXIMATELY 50 MG/DL PER CHECK. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #268 - 3004753838-2025-255108 SEVERE
View on MAUDE
Date of Event 2025-08-26
Patient Gender Female
Patient Age 34 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. | IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN. ON THE MORNING OF (B)(6) 2025, THE PATIENT EXPERIENCED DKA (DIABETIC KETOACIDOSIS) AND WAS BARELY CONSCIOUS. THE BG READING BEFORE AMBULANCE ARRIVED WAS 1086 MG/DL AND HER HUSBAND WAS NOT ABLE TO GET HER CGM READINGS AND HER PUMP REPORTEDLY MALFUNCTIONED. HER HUSBAND CALLED THE 911 AT AROUND 1100AM AND THE PATIENT WAS TAKEN TO THE HOSPITAL. IN THE AMBULANCE THE BG READING WAS SHOWING HIGH. THE PATIENT WAS TREATED WITH IV INSULIN AND ADMITTED TO THE ICU (INTENSIVE CARE UNIT). BLOODWORK WAS DONE IN THE HOSPITAL. HER DEXCOM TRANSMITTER AND SENSOR WAS REMOVED THE DAY SHE WAS IN EMERGENCY AND WAS THROWN AWAY. AT THE TIME OF THE REPORT AT THE HOSPITAL ON (B)(6) 2025 THE BG WAS 165 MG/DL. THE PATIENT WAS STILL IN THE ICU FOR CLOSE MONITORING. DATA HAS BEEN REQUESTED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.
Report #269 - 3004753838-2025-253808 SEVERE
View on MAUDE
Date of Event 2025-08-26
Patient Gender Male
Patient Age 59 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT A SIGNAL LOSS OCCURRED. ACCORDING TO THE PATIENT, ON (B)(6) 2025, THE PATIENT FELL TO THE GROUND AND HAD TO CALL AN EMERGENCY DOCTOR. EMERGENCY MEDICAL SERVICES (EMS) CHECKED THE PATIENT¿S BLOOD GLUCOSE WHICH WAS 21 MG/DL AND THE PATIENT WAS IN SEVERE HYPOGLYCEMIA. THE CONTINUOUS GLUCOSE MONITOR (CGM) WAS DISPLAYING SIGNAL LOSS ON BOTH THE SMARTPHONE AND THE SMARTWATCH. THE PATIENT WAS TREATED WITH LIQUID GLUCOSE (NO INFORMATION IF ORAL OR IV). AT THE TIME OF THE REPORT THE PATIENT WAS FINE BUT HAD SLIGHT PAIN DUE TO THE FALL. THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION. DATA HAS BEEN REQUESTED BUT IS PENDING EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.
Report #270 - 3004753838-2025-254214 SEVERE
View on MAUDE
Date of Event 2025-08-25
Patient Gender Male
Patient Age 55 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT A PAIRING ISSUE OCCURRED. THE PATIENT TRIED TO INSERT A SENSOR INTO THE ARM (B)(6) 2025 BUT WAS UNABLE TO PAIR TO THE RECEIVER. EVEN THOUGH IT DIDN'T PAIR, HE STILL HAD THE SENSOR WITH HIM. HE DIDN'T CHECK A BG BY FINGERSTICK. HE DIDN'T ATTEMPT TO CHANGE THE SENSOR. HE WAS STILL WEARING THE SENSOR WHEN HE EXPERIENCED SLURRED SPEECH, SLURRED FACE, AND INCOHERENCE. HE WENT TO THE HOSPITAL ON THE MORNING OF (B)(6) 2025 BY AMBULANCE. AT THE HOSPITAL THE DOCTOR AND NURSE TRIED TO PAIR HIS SENSOR WITH HIS RECEIVER BUT COULDN'T PAIR. THE BG READING WAS 1000 MG/DL. HE WAS IN THE INTENSIVE CARE UNIT (ICU) FOR ONE DAY. THE DOCTOR GAVE HIM INSULIN DRIP (2 BAGS) AND A POTASSIUM DRIP (2 BAGS). HE WAS DISCHARGED FROM THE HOSPITAL ON THE DAY OF THE REPORT ((B)(6) 2025) AND WAS FEELING OKAY. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA. H6 HEALTH EFFECT - CLINICAL CODE - E0131 SPEECH DISORDER.
Report #271 - 3004753838-2025-246596 SEVERE
View on MAUDE
Date of Event 2025-08-25
Patient Gender Female
Patient Age 40 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. THE PATIENT'S HUSBAND REPORTED THAT ON (B)(6) 2025 THE PATIENT DEVELOPED SYMPTOMS OF NAUSEA, VOMITING, AND ABDOMINAL PAIN AND WAS TRANSPORTED TO THE HOSPITAL. NO TREATMENT WAS ADMINISTERED AT HOME, AND NO FINGERSTICK (FS) BLOOD GLUCOSE TEST WAS PERFORMED PRIOR TO THE PATIENT BEING TAKEN TO THE HOSPITAL. WHILE AT THE HOSPITAL, THE PATIENT'S BLOOD GLUCOSE WAS MEASURED AT 33.7 MMOL/L VIA FINGERSTICK, WHILE THE DEXCOM CGM READING WAS 7.5 MMOL/L. ON (B)(6) 2025 THE PATIENT WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA) AND ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR TREATMENT (IV INSULIN THERAPY). AS OF (B)(6) 2025, THE PATIENT REMAINED IN THE ICU UNDER CONTINUOUS OBSERVATION AND ONGOING MANAGEMENT BY THE CRITICAL CARE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS.
Report #272 - 3004753838-2025-250179 SEVERE
View on MAUDE
Date of Event 2025-08-24
Patient Gender Female
Patient Age 74 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2025. ACCORDING TO THE PATIENT, SHE "MENTIONED THAT SHE'S BEEN IN INTENSIVE CARE UNIT (ICU) FOR DAYS." THERE IS NO CONNECTION BETWEEN THE WEARABLE FAILURE DOCUMENTED AS HAVING OCCURRED THE SAME DAY AS THE CALL AND THE ICU HOSPITALIZATION OCCURRING "DAYS' BEFOREHAND. THERE ARE NO OTHER DETAILS WITH WHICH TO ASSESS THIS REPORT. NO PATIENT SYMPTOMS WERE REPORTED. THE PATIENT REFUSED TO PROVIDE DEXCOM WITH ANY FURTHER EVENT DETAILS. DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS NOT CONFIRMED VIA DATA. HOWEVER, NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE UNDER AN HOUR WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4) H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED.
Report #273 - 3004753838-2025-250424 SEVERE
View on MAUDE
Date of Event 2025-08-23
Patient Gender Female
Patient Age 18 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ABDOMEN, WHICH IS OFF-LABEL USAGE OF THE DEVICE, ON (B)(6) 2025. ACCORDING TO THE PATIENT, ON (B)(6) 2025, THE CGM WAS READING LOW AND THE PATIENT WAS ASYMPTOMATIC AT THE TIME. NO BG METER COMPARISON VALUE WAS TAKEN. ONCE AT HOME, THE PATIENT SELF-TREATED WITH ¿A LOT OF SUGAR¿ DUE TO THE LOW CGM READINGS. AFTER EATING, THE PATIENT BEGAN TO FEEL DIZZY, CONFUSED, HAD A STOMACHACHE, DIFFICULTY SWALLOWING, AND A FEVER. SHE CALLED EMERGENCY MEDICAL SERVICES (EMS) AND WHEN THEY ARRIVED, A BG METER READING WAS TAKEN BUT THE VALUE COULD NOT BE RECALLED. SHE WAS TRANSPORTED TO THE EMERGENCY ROOM (ER). AT THE ER, THE PATIENT¿S BG METER READING WAS 656 MG/DL WHILE THE CGM WAS READING LOW. THE PATIENT WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS AND TREATED WITH AN INTRAVENOUS (IV) INSULIN DRIP. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND WAS STILL THERE BUT FEELING BETTER AT THE TIME OF THE REPORT. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS.
Report #274 - 3004753838-2025-252040 SEVERE
View on MAUDE
Date of Event 2025-08-21
Patient Gender Female
Patient Age 48 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. ON APPROXIMATELY 08/21/2025, THE CGM WAS CONSISTENTLY SHOWING 126 MGDL, HOWEVER, SHE WAS FEELING HIGH SYMPTOMS FOR A FEW DAYS (ABDOMINAL PAIN, DIARRHEA FATIGUE, AND THIRST). SHE DIDN'T USE HER BGM AT HOME TO COMPARE THE READINGS AND NO SELF-TREATMENT DONE AS SHE WAS THINKING IT WILL SUBSIDE. SHE THEN DECIDED TO CALL AN AMBULANCE ON (B)(6) /2025 AT 1AM BECAUSE SHE COULD NOT BEAR THE SYMPTOMS ANYMORE. AT THE EMERGENCY ROOM (ER) THEY DID A FINGERSTICK AND SHOWED MORE THAN 500 MGDL WHILE THE CGM WAS AT 155 MGDL. THEY DID BLOOD WORK AND SHE WAS DIAGNOSE WITH DIABETIC KETOACIDOSIS (DKA) AND SHE BROUGHT TO THE INTENSIVE CARE UNIT (ICU) UNTIL THE (B)(6) 2025. SHE WAS GIVEN IV FLUID AND INSULIN. THE PATIENT DID NOT KNOW THE CGM OR BG READINGS WHILE SHE WAS IN THE ICU. THE PATIENT IS STILL IN THE HOSPITAL BUT IN A REGULAR ROOM AND CURRENTLY FEELING BETTER WITH THE BG READING OF 160MGDL AT THE TIME OF THE REPORT. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID AT THE ER. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #275 - 3004753838-2025-250161 SEVERE
View on MAUDE
Date of Event 2025-08-21
Patient Gender Female
Patient Age 56 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT REPORTED VOMITING BLOOD. AT THE TIME OF THE ISSUE, THE CGM DISPLAYED A READING OF 70 MG/DL. HOWEVER, THE PATIENT WAS UNABLE TO VERIFY HER ACTUAL BLOOD GLUCOSE LEVEL DUE TO THE LACK OF A GLUCOMETER. THE FOLLOWING DAY, THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM AND WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) WHERE HER BLOOD GLUCOSE LEVEL WAS RECORDED AT 900 MG/DL. THE CGM WAS REMOVED AT THE HOSPITAL, THUS NO CONFIRMED READINGS ON THE CGM. THE PATIENT WAS PLACED ON AN INSULIN DRIP AND WAS DISCHARGED THE NEXT MORNING. THE PATIENT REPORTED HER CURRENT CONDITION AS STABLE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #276 - 3004753838-2025-247225 SEVERE
View on MAUDE
Date of Event 2025-08-20
Patient Gender Female
Patient Age 31 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. THE PATIENT EXPERIENCED A WEARABLE FAILURE ON THE SAME DAY THE DEXCOM G7 SENSOR WAS INSERTED INTO HER ARM. THE G7 APP DISPLAYED A "SENSOR FAILED" MESSAGE. DURING THIS TIME, THE PATIENT REPORTED FEELING DIZZY, SLEEPY, AND VOMITING. SHE PERFORMED A FINGERSTICK BLOOD GLUCOSE TEST, WHICH SHOWED A READING OF 30 MG/DL, WHILE THE DEXCOM G7 APP CONTINUED TO DISPLAY THE SENSOR FAILURE. DESPITE EXPERIENCING SYMPTOMS OF SEVERE HYPOGLYCEMIA, THE PATIENT DID NOT TAKE ANY MEDICATION PRIOR TO SEEKING MEDICAL ATTENTION. SHE WENT ALONE TO HER PRIMARY CARE PROVIDER'S CLINIC. UPON ARRIVAL, HER DOCTOR PERFORMED A FINGERSTICK TEST, BUT THE PATIENT CANNOT RECALL THE RESULT. THE DOCTOR ADMINISTERED ORANGE JUICE AND GLUCOSE SYRUP TO ADDRESS THE HYPOGLYCEMIA AND CALLED PARAMEDICS. WHEN THE PARAMEDICS ARRIVED, THEY ALSO PERFORMED A FINGERSTICK TEST, BUT THE PATIENT DOES NOT REMEMBER THE READING, OR THE MEDICATION PROVIDED BY THE PARAMEDICS. SHE REMAINED AT THE CLINIC FOR SEVERAL HOURS AND WAS DISCHARGED AFTER HER SYMPTOMS IMPROVED. DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS CONFIRMED VIA DATA. THE PROBABLE CAUSE WAS DETERMINED TO BE VERY LOW COUNT ABERRATION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4) H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.
Report #277 - 3004753838-2025-240536 SEVERE
View on MAUDE
Date of Event 2025-08-14
Patient Gender Female
Patient Age 76 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT¿S CGM READINGS RANGED BETWEEN 54 AND 69 MG/DL. IN RESPONSE, THE PATIENT SELF-TREATED WITH GLUCOSE, WHICH RESULTED IN A TEMPORARY INCREASE IN CGM READINGS TO 70 MG/DL. ALTHOUGH THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS, THEY WENT TO THE EMERGENCY ROOM DUE TO CONCERN THAT THE CGM READINGS WERE NOT IMPROVING. AT THE HOSPITAL, A FINGERSTICK BLOOD GLUCOSE READING WAS RECORDED AT OVER 500 MG/DL. THE PATIENT COULD NOT RECALL THE CGM READING AT THAT TIME. THE PATIENT WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA) AND ADMITTED TO THE INTENSIVE CARE UNIT (ICU), WHERE THEY WERE TREATED WITH INTRAVENOUS INSULIN. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITH A BLOOD GLUCOSE READING OF 134 MG/DL. THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR FOLLOW-UP INTERVENTION. ALTHOUGH THE REPORT STATES THE PATIENT WAS DISCHARGED THE NEXT/FOLLOWING DAY, THE LENGTH OF TIME IN THE HOSPITAL (LESS THAN OR MORE THAN 24 HOURS) IS UNKNOWN. AT THE TIME OF REPORTING, THE PATIENT WAS STABLE. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS
Report #278 - 3004753838-2025-250171 SEVERE
View on MAUDE
Date of Event 2025-08-13
Patient Gender Female
Patient Age 61 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT WAS AT HOME WHEN THEY FELT DIZZY AND HAD A "FAST HEARTBEAT" AND DIFFICULTY BREATHING. THE CGM WAS 189 MG/DL BUT THEY WERE UNABLE TO CHECK THEIR BG. THEY STARTED VOMITING AND CONTINUED TO HAVE DIFFICULTY BREATHING. THE PATIENT'S SPOUSE CALLED AN AMBULANCE AND WHEN THEY ARRIVED, EMERGENCY MEDICAL TECHNICIANS CHECKED HER BG AND IT WAS 630 MG/DL WHILE THE CGM WAS STILL 189 MG/DL. THE PATIENT WAS TREATED WITH LIQUID IV AND INSULIN SHOTS AND TAKEN TO THE HOSPITAL. THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT AND THEY REMOVED THE INSULIN PUMP AND SENSOR. WHEN THEY CHECKED A BG IT WAS 599 MG/DL. THE PATIENT WAS IN THE ICU FOR 2 DAYS AND CONTINUED TO RECEIVE LIQUID IV TREATMENT UNTIL SHE WAS DISCHARGED. AT THE TIME OF THE REPORT, THE PATIENT WAS FEELING BETTER. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR WHEN THE PATIENT WAS SYMPTOMATIC. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID WHEN PARAMEDICS ARRIVED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA.
Report #279 - 3004753838-2025-250173 SEVERE
View on MAUDE
Date of Event 2025-08-11
Patient Gender Female
Patient Age 68 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. IT WAS INDICATED THAT THE PATIENT USED AN ALTERNATE BLOOD GLUCOSE TEST SITE, WHICH IS MISUSE OF THE DEVICE. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT'S DEXCOM MOBILE DEVICE SHOWED CGM LOW. THE PATIENT USES INSULET OMNIPOD5 IN MODIFIED CLOSED LOOP AND WAS FEELING NAUSEA, COULD NOT WALK, AND HAVING DIARRHEA. THE BG WAS NOT CHECKED. HER SPOUSE BROUGHT HER TO THE HOSPITAL WHERE SHE WAS IN INTENSIVE CARE UNIT (ICU). WHEN SHE ARRIVED, THEY CHECK HER BG METER IT SHOWS 300 MG/DL BUT ON DEXCOM IT STILL SAYS LOW. SHE HAD DKA. HER SPOUSE COULD NOT REMEMBER THE MEDICATIONS THAT WERE GIVEN TO HER DURING HER STAY BUT SHE HAD BLOODWORK. ON (B)(6) 2025, THE PATIENT GOT DISCHARGED. HER GLUCOSE AT THE TIME WAS 88 MG/DL AND CONFIRMED THAT SHE WAS FEELING FINE NOW. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. IN THE ICU, THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #280 - 3004753838-2025-239901 SEVERE
View on MAUDE
Date of Event 2025-08-11
Patient Gender Female
Patient Age 67 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT HAD SEVERE WEAKNESS, PERSISTENT VOMITING, HEADACHE AND DIFFICULTY AMBULATING THROUGHOUT THE DAY. THE PATIENT'S BLOOD PRESSURE WAS REPORTEDLY ELEVATED WITH A LEVEL OF 290 MMHG. THE CGM WAS DISPLAYING LOW GLUCOSE READINGS BUT A BG FINGER STICK WAS NOT TAKEN FOR COMPARISON. THE PATIENT DID NOT TAKE ANY MEDICATION OR RECEIVE CARE AND WAS TAKEN TO THE HOSPITAL. UPON ARRIVAL, LABORATORY TESTS SHOWED HIGH GLUCOSE LEVEL OF 800 MG/DL WHILE THE CGM CONTINUED TO SHOW LOW READINGS. THE PATIENT'S HUSBAND REPLACED THE SENSOR THAT WAS REPORTEDLY FAULTY AND THE NEW SENSOR PROVIDED ACCURATE READINGS. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND WAS HOSPITALIZED FOR 4 DAYS. WHILE IN THE HOSPITAL, THE PATIENT WAS REPORTEDLY TREATED WITH IV HEPARIN, DESPITE THIS MEDICATION NOT BEING TREATMENT FOR HYPERGLYCEMIA. THAT PATIENT WAS DISCHARGED ON (B)(6) 2025 IN STABLE CONDITION. AT THE TIME OF THE REPORT, THE PATIENT WAS DOING OKAY BUT WAS STILL WEAK AND DIZZY. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA.
Report #281 - 3004753838-2025-238639 SEVERE
View on MAUDE
Date of Event 2025-08-11
Patient Gender N/A
Patient Age N/A
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). B5: DESCRIBE EVENT OR PROBLEM - CORRECTION. H2 TYPE OF FOLLOW UP: CORRECTION. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ACCORDING TO THE PATIENT¿S SPOUSE, ON (B)(6) 2025, THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT THAT LED TO A MOTOR VEHICLE ACCIDENT. AT 4:27 PM, CGM ALERTED THE PATIENT OF A LOW GLUCOSE VALUE OF 71 MG/DL. AT THAT TIME, THE PATIENT DID NOT REPORT ANY NOTICEABLE SYMPTOMS, BUT HE TOOK PRECAUTIONARY ACTION BY STOPPING AT A STORE TO CONSUME A GRANOLA BAR AND SUNNY DELIGHT JUICE. HIS WIFE, WHO ALSO RECEIVED THE CGM ALERT ON HER FOLLOW APP, CALLED TO REMIND HIM TO EAT SOMETHING. AROUND 5:00 PM, HE DRIFTED OFF THE ROAD, WHICH WAS LATER CONFIRMED TO BE DUE TO SEVERE HYPOGLYCEMIA. EMERGENCY MEDICAL TECHNICIANS (EMT) FOUND THE PATIENT DISORIENTED AND PERFORMED A FINGERSTICK TEST SHOWING A CRITICALLY LOW BLOOD GLUCOSE LEVEL OF 20 MG/DL. THE CGM READING WAS NOT DOCUMENTED, THOUGH IT WAS "PRESUMABLY CONSISTENT WITH THE DANGEROUSLY LOW LEVEL." THE PATIENT¿S WIFE, HOWEVER, STATED THAT THE CGM WAS 132 TO 140 MG/DL POINTS APART FROM THE BG. EMT TREATED THE PATIENT WITH IV DEXTROSE AT THE SCENE, AND THE PATIENT RESPONDED WITHIN APPROXIMATELY 25 MINUTES. UPON ARRIVAL AT THE EMERGENCY ROOM (ER), THE PATIENT WAS MONITORED AND DID NOT RECEIVE ADDITIONAL MEDICATIONS. THE PATIENT HAD SEATBELT-RELATED BRUISE, AND NO OTHER TRAUMA WAS NOTED. AT AN UNSPECIFIED TIME, THE PATIENT REMOVED THE SENSOR. THE PATIENT WAS STABLE AND DISCHARGED IN LESS THAN 24 HOURS, RETURNING TO WORK THE FOLLOWING DAY. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ACCORDING TO THE PATIENT¿S SPOUSE, ON (B)(6) 2025, THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT THAT LED TO A MOTOR VEHICLE ACCIDENT. AT 4:27 PM, CGM ALERTED THE PATIENT OF A LOW GLUCOSE VALUE OF 72 MG/DL. AT THAT TIME, THE PATIENT DID NOT REPORT ANY NOTICEABLE SYMPTOMS, BUT HE TOOK PRECAUTIONARY ACTION BY STOPPING AT A STORE TO CONSUME A GRANOLA BAR AND SUNNY DELIGHT JUICE. HIS WIFE, WHO ALSO RECEIVED THE CGM ALERT, CALLED TO REMIND HIM TO EAT SOMETHING. AROUND 5:00 PM, HE DRIFTED OFF THE ROAD, WHICH WAS LATER CONFIRMED TO BE DUE TO SEVERE HYPOGLYCEMIA. EMERGENCY MEDICAL TECHNICIANS (EMT) FOUND THE PATIENT DISORIENTED AND PERFORMED A FINGERSTICK TEST SHOWING A CRITICALLY LOW BLOOD GLUCOSE LEVEL OF 20 MG/DL. THE CGM READING WAS NOT DOCUMENTED, THOUGH IT WAS "PRESUMABLY CONSISTENT WITH THE DANGEROUSLY LOW LEVEL." EMT TREATED THE PATIENT WITH IV DEXTROSE AT THE SCENE, AND THE PATIENT RESPONDED WITHIN APPROXIMATELY 25 MINUTES. UPON ARRIVAL AT THE EMERGENCY ROOM (ER), THE PATIENT WAS MONITORED AND DID NOT RECEIVE ADDITIONAL MEDICATIONS. THE PATIENT HAD SEATBELT-RELATED BRUISING, AND NO OTHER TRAUMA WAS NOTED. THE PATIENT WAS STABLE AND DISCHARGED IN LESS THAN 24 HOURS, RETURNING TO WORK THE FOLLOWING DAY. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE PRODUCT WAS RECEIVED AND EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND NO DAMAGE WAS FOUND. NORDIC BLUETOOTH PAIRING TEST WAS PERFORMED AND PASSED. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER WAS NOT FOUND AS NO METER VALUES ARE PRESENT AND/OR NO METER VALUES THAT ARE INACCURATE ARE PRESENT WITHIN THE INVESTIGATION WINDOW. THE CUSTOMER COMPLAINT IS UNDETERMINED AS ANALYSIS WOULD NOT BE ABLE TO CONFIRM THE COMPLAINT NOR DETERMINE A POTENTIAL ROOT CAUSE. THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4).
Report #282 - 3004753838-2025-242650 SEVERE
View on MAUDE
Date of Event 2025-08-10
Patient Gender Male
Patient Age 41 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE SKIN. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT HAS BEEN HOSPITALIZED IN THE INTENSIVE CARE UNIT (ICU) ON THIRTY-ONE SEPARATE OCCASIONS (THIS RECORD WAS CREATED TO CAPTURE THE MULTIPLE HOSPITALIZATIONS REPORTED). ACCORDING TO THE PATIENT, THESE HOSPITALIZATIONS WERE THE RESULT OF FALSE READINGS FROM HIS MONITORING DEVICES, WHICH LED HIM TO BELIEVE HIS CONDITION WAS STABLE WHEN, IN FACT, IT WAS NOT. THERE WERE NO BG NOR CGM VALUES REPORTED. THE PATIENT DECLINED TO PROVIDE FURTHER INFORMATION ABOUT THE EVENT. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #283 - 3004753838-2025-241184 SEVERE
View on MAUDE
Date of Event 2025-08-10
Patient Gender Male
Patient Age 41 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE SKIN. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT HAS BEEN HOSPITALIZED IN THE INTENSIVE CARE UNIT (ICU) ON THIRTY-ONE SEPARATE OCCASIONS. ACCORDING TO THE PATIENT, THESE HOSPITALIZATIONS WERE THE RESULT OF FALSE READINGS FROM HIS MONITORING DEVICES, WHICH LED HIM TO BELIEVE HIS CONDITION WAS STABLE WHEN, IN FACT, IT WAS NOT. THERE WAS NO BG NOR CGM VALUES REPORTED. THE PATIENT DECLINED TO PROVIDE FURTHER INFORMATION ABOUT THE EVENT. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #284 - 3004753838-2025-234483 SEVERE
View on MAUDE
Date of Event 2025-08-05
Patient Gender Male
Patient Age 12 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE UPPER BUTTOCKS, WHICH IS OFF-LABEL USAGE OF THE DEVICE, ON (B)(6) 2025. THE DATE OF THE EVENT IS AN APPROXIMATION. ACCORDING TO A REPORT RECEIVED VIA THE DISTRIBUTOR, IT WAS REPORTED THAT A PEDIATRIC PATIENT EXPERIENCED CGM INACCURACY. ON (B)(6) 2025, THE PATIENT EXPERIENCED VOMITING AND WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT WAS INITIALLY TREATED AT HOME BY A PARENT WITH 4 UNITS OF INSULIN BEFORE BEING TAKEN TO THE HOSPITAL, WHERE THEY WERE ADMITTED TO THE INTENSIVE CARE UNIT (ICU). AT AN UNSPECIFIED TIME DURING THE EVENT, THE CGM READING WAS 44 MG/DL, WHILE THE BLOOD GLUCOSE (BG) READING WAS 484 MG/DL. ADDITIONAL MEASUREMENTS INCLUDED BG: 370 MG/DL, WHILE CGM: 45 MG/DL AND BG: 320 MG/DL, WHILE CGM WAS READING LOW. DURING HOSPITALIZATION, THE PATIENT RECEIVED TREATMENT INCLUDING ELECTROLYTES, POTASSIUM VIA IV, AND INSULIN INJECTIONS. THE PATIENT WAS ADMITTED ON (B)(6) 2025 AND DISCHARGED ON (B)(6) 2025, WITH A HOSPITAL STAY EXCEEDING 24 HOURS. AT THE TIME OF THE EVENT, THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS.
Report #285 - 3004753838-2025-232948 SEVERE
View on MAUDE
Date of Event 2025-08-05
Patient Gender Male
Patient Age 17 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE UPPER BUTTOCKS WHICH IS AN OFF-LABEL USAGE OF THE DEVICE. ON (B)(6) 2025, THE PATIENT WAS HOSPITALIZED. AT THE TIME OF THE INCIDENT, THE DEXCOM MOBILE DEVICE DISPLAYED A LEVEL OF 256 MG/DL, WHILE THE PATIENT WAS EXPERIENCING SYMPTOMS INCLUDING VOMITING, DIZZINESS, AND FATIGUE. NO FINGERSTICK (FS) TEST WAS PERFORMED AT HOME; THE PARENT PROVIDED SOUP, BUT THE PATIENT¿S CONDITION DID NOT IMPROVE. THE PARENT BROUGHT THE PATIENT TO THE EMERGENCY ROOM (ER), WHERE AN FS TEST REVEALED A GLUCOSE LEVEL OF 480 MG/DL, WHILE THE CGM CONTINUED TO SHOW 257 MG/DL. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU), WHERE A NURSE ADMINISTERED MEDICATION AND PERFORMED ANOTHER FS TEST. HOWEVER, THE PARENT WAS NOT INFORMED OF THE SPECIFIC MEDICATION ADMINISTERED OR THE UPDATED GLUCOSE READINGS DURING THE HOSPITAL STAY IN BOTH THE ER AND ICU. THE PATIENT WAS DISCHARGED ON (B)(6) 2025IN THE AFTERNOON AND WAS REPORTED TO BE DOING OKAY AT THE TIME OF FOLLOW-UP. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR WHILE THE PATIENT WAS EXPERIENCING SYMPTOMS. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID ON (B)(6) 2025. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #286 - 3004753838-2025-230257 SEVERE
View on MAUDE
Date of Event 2025-07-29
Patient Gender Female
Patient Age 61 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA. | IT WAS REPORTED THAT A SIGNAL LOSS OCCURRED. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SIGNAL LOSS AT AROUND 8PM WITH THE PATIENT¿S OMNIPOD AND DEXCOM RECEIVER AND THEY WERE NOT PROVIDING THE PATIENT WITH ANY CGM VALUES. THE PATIENT WAS ASYMPTOMATIC AND WENT TO SLEEP THINKING THE ISSUE WOULD RESOLVE ITSELF. ON (B)(6) 2025, THE PATIENT WOKE UP NAUSEOUS AND COULD NOT GET OUT OF BED. THE PATIENT¿S CGM WAS STILL IN A SIGNAL LOSS STATE. NO BG METER READING WAS REPORTED AT THIS TIME. THE PATIENT CALLED HER DOCTOR TO CANCEL AN APPOINTMENT SHE HAD FOR THAT DAY AND WHEN EXPLAINING WHY, THE PATIENT¿S DOCTOR CALLED EMERGENCY MEDICAL SERVICES (EMS). ONCE EMS ARRIVED, THE PATIENT¿S BG METER READING WAS 500 MG/DL. THE PATIENT WAS TREATED WITH AN UNSPECIFIED IV AND TRANSPORTED TO THE EMERGENCY ROOM (ER). AT THE ER, THE PATIENT WAS TREATED WITH OTHER UNSPECIFIED MEDICATIONS THAT SHE COULD NOT RECALL AND ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT WAS DISCHARGED HOME THE FOLLOWING EVENING, ON (B)(6) 2025 (MORE THAN 24 HOURS). THE PATIENT WAS ¿FINE¿ AT THE TIME OF REPORT. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Report #287 - 3004753838-2025-243569 SEVERE
View on MAUDE
Date of Event 2025-07-22
Patient Gender Female
Patient Age 86 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE CGM WAS DISPLAYING 85 MG/DL AND THE HOME CARE FACILITY THAT THE PATIENT WAS AT GAVE THE PATIENT A CINNAMON CRACKER WITH PEANUT BUTTER AND A GLUCAGON SHOT BASED ON THE CGM READING. PRIOR TO THIS DAY, THE PATIENT'S SON MENTIONED THE PATIENT'S BG READINGS WERE HIGH (UNKNOWN IF THIS WAS THE CGM READING OR MANUAL BG READING). A BG TEST WAS TAKEN ON (B)(6) 2025 WHEN THE CGM WAS 85 MG/DL AND IT WAS 450 MG/DL. AN AMBULANCE WAS CALLED AND THE PATIENT WAS TAKEN TO THE HOSPITAL WHERE THEY WERE IN THE INTENSIVE CARE UNIT FOR 2 AND A HALF DAYS. THEY WERE TREATED WITH IV INSULIN AND MOVED TO A REGULAR ROOM FOR 3 DAYS. AT THE TIME OF THE REPORT, THE PATIENT WAS FEELING ALL RIGHT. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR WHEN THE PATIENT WAS FIRST GIVEN FOOD AND NO BG WAS TAKEN. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID PRIOR TO BEING TAKEN TO THE HOSPITAL. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #288 - 3004753838-2025-239014 SEVERE
View on MAUDE
Date of Event 2025-07-22
Patient Gender N/A
Patient Age N/A
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
SUBSEQUENT TO THE INITIAL MDR, CLARIFICATION WAS PROVIDED ON 08/28/2025. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT EXPERIENCED SYMPTOMS INCLUDING DEHYDRATION, CONFUSION, AND BODY ACHES. THERE WAS NO DOCUMENTATION OF CGM READINGS AT THE TIME OF THE EVENT. THE PATIENT CALLED 911, AND UPON EMS ARRIVAL, HER BLOOD GLUCOSE METER READINGS RANGED BETWEEN 184-200 MG/DL. NO CGM COMPARISON VALUES WERE REPORTED. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM, WHERE SHE WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA). TREATMENT INCLUDED IV FLUIDS AND INSULIN ADMINISTRATION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). | (B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS. H6 CODES: HEALTH EFFECT - CLINICAL CODE PROBLEM CODE: E2304 CHILLS / CODE NOT AVAILABLE H6 CODES: HEALTH EFFECT - CLINICAL CODE PROBLEM CODE : CORRECTION TO DISREGARD 4581 APPROPRIATE TERM/CODE NOT AVAILABLE. | IT WAS REPORTED THAT UNSPECIFIED MALFUNCTION OCCURRED. ON (B)(6) 2025, AT APPROXIMATELY 3-4 A.M., THE PATIENT AWOKE FEELING UNWELL. AFTER EATING BREAKFAST, SHE RETURNED TO SLEEP BUT LATER WOKE UP WITH WORSENED SYMPTOMS, INCLUDING FEVER, CHILLS, ABDOMINAL PAIN, VISUAL IMPAIRMENT, CONFUSION, AND BODY ACHES. THERE WAS NO DOCUMENTATION OF CONTINUOUS GLUCOSE MONITOR (CGM) READINGS AT THE TIME OF SYMPTOMS. THE PATIENT CALLED 911, AND EMERGENCY MEDICAL SERVICES (EMS) ARRIVED. A BLOOD GLUCOSE (BG) METER READING WAS TAKEN, SHOWING VALUES BETWEEN 184¿200 MG/DL. NO CGM COMPARISON WAS REPORTED. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM (ER), WHERE SHE WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT WAS UNABLE TO RECALL SPECIFIC DETAILS REGARDING THE MEDICATION OR TREATMENT RECEIVED DURING HER HOSPITAL STAY. SHE WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND DISCHARGED ON (B)(6) 2025. AT THE TIME OF THE REPORT, THE PATIENT WAS STABLE AND STATED SHE WAS ¿OKAY.¿ NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #289 - 3004753838-2025-268562 SEVERE
View on MAUDE
Date of Event 2025-07-20
Patient Gender Female
Patient Age 68 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). MEDWATCH REPORT (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA. H6 CODES: HEALTH EFFECT - IMPACT CODE PROBLEM CODE: F18 REHABILITATION/ CODE NOT AVAILABLE. H6 CODES: HEALTH EFFECT - IMPACT CODE PROBLEM CODE: CORRECTION TO DISREGARD 4650 APPROPRIATE TERM/CODE NOT AVAILABLE. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE EVENT DATE IS AN APPROXIMATION. IT WAS REPORTED BY (B)(6), ALONG WITH AN ACCOMPANYING MEDWATCH REPORT (B)(4), THAT THE PATIENT EXPERIENCED INACCURATE CGM VALUES. ON (B)(6) 2025, THE PATIENT¿S CGM DISPLAYED CONSISTENTLY BETWEEN 200-220 MG/DL, WHILE A BG METER READING SHOWED 300 MG/DL. DURING THIS TIME, THE PATIENT EXHIBITED SIGNS OF SEVERE HYPERGLYCEMIA, INCLUDING IRRITABILITY, MOOD CHANGES, DISORIENTATION, AND SIGNIFICANT PHYSICAL IMPAIRMENT, SHE WAS BARELY ABLE TO WALK OR HOLD OBJECTS. EMERGENCY MEDICAL SERVICES (EMS) WERE CONTACTED. UPON ARRIVAL, THE CGM CONTINUED TO READ 200 MG/DL, WHILE THE BG METER INDICATED A CRITICALLY HIGH LEVEL OF 500 MG/DL. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM (ER), WHERE HER CGM STILL READ 200 MG/DL, BUT HER BG LEVEL WAS CONFIRMED TO BE 1100 MG/DL. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR ONE WEEK, FOLLOWED BY A ONE-WEEK STAY IN A GENERAL HOSPITAL ROOM. THERE IS NO DOCUMENTATION AVAILABLE REGARDING THE SPECIFIC MEDICATIONS OR TREATMENTS ADMINISTERED DURING HER HOSPITALIZATION. AFTER DISCHARGE, THE PATIENT WAS TRANSFERRED TO A REHABILITATION FACILITY FOR AN ADDITIONAL WEEK. NO FURTHER PATIENT DETAILS OR EVENT DOCUMENTATION WERE AVAILABLE. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID WHEN THE PATIENT EXHIBITED SIGNS OF SEVERE HYPERGLYCEMIA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID WHEN EMS CHECKED AND WAS TRANSPORTED TO THE ER. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #290 - 3004753838-2025-250238 SEVERE
View on MAUDE
Date of Event 2025-07-20
Patient Gender Female
Patient Age 68 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA. H6 HEALTH EFFECT: IMPACT CODE: F18: REHABILITATION. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ABDOMEN. ON APPROXIMATELY (B)(6) 2025, THE PATIENT'S CGM WAS 300 MG/DL WHILE THE CGM WAS RANGING BETWEEN 200-220 MG/DL. THE PATIENT WAS REPORTEDLY IRRITABLE, MOODY, DISORIENTED AND BARELY ABLE TO WALK OR HOLD ANYTHING. THE PATIENT'S DAUGHTER CALLED AN AMBULANCE AND UPON ARRIVAL, THEY CHECKED A BG AND IT WAS 500 MG/DL WHILE THE CGM WAS 200 MG/DL. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. AT THE HOSPITAL, THE PATIENT'S BG WAS 1100 MG/DL WHILE THE CGM WAS STILL 200 MG/DL. THE SENSOR WAS REMOVED IN THE INTENSIVE CARE UNIT (ICU). TREATMENT IN THE ICU COULD NOT BE REMEMBERED. THE PATIENT WAS IN THE ICU FOR ONE WEEK AND TRANSFERRED TO A REGULAR ROOM FOR ANOTHER WEEK. AT THE TIME OF THE REPORT, THE PATIENT WAS DOING OKAY. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR WHEN THE PATIENT WAS SYMPTOMATIC. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID WHEN PARAMEDICS ARRIVED. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). | THE WEARABLE WAS INSERTED INTO THE ABDOMEN, WHICH IS AN OFF LABEL USAGE OF THE DEVICE.
Report #291 - 3004753838-2025-232866 SEVERE
View on MAUDE
Date of Event 2025-07-18
Patient Gender Male
Patient Age 59 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. DATE OF EVENT IS AN APPROXIMATION. ON (B)(6) 2025, IT WAS REPORTED BY INSULET PARTNER TO THE INTERNATIONAL TEAM THAT THE PATIENT EXPERIENCED INACCURATE CGM VALUES. IT HAS BEEN REPORTED THAT ''THE VALUES WERE DIFFERENT BUT COULD NOT PROVIDE WHAT THE EXACT VALUES WERE ON THE DEXCOM APP AND ON THE CONTROLLER.'' . THE PATIENT WAS VOMITING AND HAD DRY MOUTH AND DECIDED TO GO TO THE HOSPITAL. THERE THE PATIENT WAS DIAGNOSED WITH DKA. THE PATIENT WAS TREATED WITH IV MEDICATION AT THE HOSPITAL AND WAS TRANSFERRED TO THE INTENSIVE CARE. THE PATIENT WAS HOSPITALIZED FOR 8 DAYS. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALL WITHIN THE A ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #292 - 3004753838-2025-261541 SEVERE
View on MAUDE
Date of Event 2025-07-15
Patient Gender N/A
Patient Age N/A
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). B5: DESCRIBE EVENT OR PROBLEM - CORRECTION/ADDITIONAL INFORMATION. G3: DATE RECEIVED BY MFG - ADDITIONAL INFORMATION. G6: TYPE OF REPORT - UPDATED/FOLLOW-UP. H2: TYPE OF FOLLOW UP - CORRECTION/ADDITIONAL INFORMATION. H6 CODES: TYPE OF INVESTIGATION - ADDITIONAL INFORMATION. H6 CODES: INVESTIGATION FINDINGS - ADDITIONAL INFORMATION. H6 CODES: INVESTIGATION CONCLUSION - ADDITIONAL INFORMATION. H10: CORRECTED DATA. | SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION WAS RECEIVED ON 09/22/2025. DATA WAS FURTHER REVIEWED. THE ALLEGATION WAS NOT CONFIRMED VIA DATA. HOWEVER, IT WAS FOUND THAT A SENSOR FAILURE DURING WARM-UP OCCURRED. THE PROBABLE CAUSE WAS DETERMINED TO BE LOW COUNTS ABERRATION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. | IT WAS REPORTED THAT AN ADVERSE EVENT WAS REPORTED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON 07/15/2025, THE PATIENT REPORTED AN ISSUE PAIRING HIS CGM TO HIS MOBILE DEVICE, HOWEVER, THE PATIENT WAS UNABLE TO SPECIFY HOW MUCH TIME ELAPSED FROM THE PATIENT¿S PAIRING ISSUE UNTIL HE BEGAN TO FEEL SYMPTOMS. AT AN UNSPECIFIED TIME LATER, THE PATIENT WAS EXPERIENCING BLURRY VISION AND WAS ¿HAVING ABNORMAL HEART AND KIDNEY¿. NO OTHER EVENT DETAILS WERE PROVIDED. THE PATIENT WENT TO THE EMERGENCY ROOM WHERE HIS BG LEVEL WAS FOUND TO BE 1000 MG/DL. HE WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND TREATED WITH INSULIN. HE WAS DISCHARGED ON (B)(6) 2025. THE PATIENT WAS EXPERIENCING HEART PALPITATIONS AT THE TIME OF REPORT. DATA HAS BEEN REQUESTED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #293 - 3004753838-2025-228718 SEVERE
View on MAUDE
Date of Event 2025-07-13
Patient Gender Female
Patient Age 70 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON THE MORNING OF 07/13/2025, THE PATIENT EXPERIENCED SUDDEN DISORIENTATION, PROFUSE SWEATING, AND CONFUSION, OCCURRING FIVE DAYS AFTER THE DEXCOM G7 (CGM) SENSOR WAS APPLIED TO THE ARM. THE CGM MOBILE DEVICE ISSUED A LOW GLUCOSE ALERT; HOWEVER, THE BG READING REVEALED A HIGH VALUE OF 688 MG/DL. THE PATIENT WAS IMMEDIATELY ADMITTED TO THE INTENSIVE CARE UNIT (ICU). UPON ADMISSION, THE CGM SENSOR WAS REMOVED, AND A REPEAT BG TEST CONFIRMED PERSISTENT HYPERGLYCEMIA AT 688 MG/DL. THE PATIENT WAS TREATED WITH INTRAVENOUS INSULIN THERAPY AND RECEIVED HYPEROSMOLAR THERAPY TO ADDRESS ELECTROLYTE IMBALANCES. SUPPORTIVE CARE WAS PROVIDED FOR SYMPTOMS INCLUDING VOMITING, DIZZINESS, AND EXCESSIVE URINATION. THE PATIENT REMAINED IN THE ICU FOR TWO DAYS. HER CONDITION STABILIZED, AND SHE WAS DISCHARGED ON (B)(6) 2025. AT THE TIME OF THE REPORT, THE PATIENT WAS FINE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #294 - 3004753838-2025-248408 SEVERE
View on MAUDE
Date of Event 2025-07-03
Patient Gender Female
Patient Age 24 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. H6 HEALTH EFFECT - CLINICAL CODE- 4415 - SPEECH DISORDER. | IT WAS REPORTED THAT NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. AT APPROXIMATELY 6:00 PM ON (B)(6) 2025, THE PATIENT EXPERIENCED HYPERGLYCEMIA AND HAD VOMITING, ABDOMINAL PAIN, MENTAL PROBLEMS/CRAZY DREAMS, ALTERED MENTAL STATUS, SLURRED SPEECH, AND CONFUSION. THE PATIENT¿S MOTHER CALLED THE PARAMEDICS. EMERGENCY MEDICAL SERVICES (EMS) ARRIVED AND TOOK A FINGERSTICK AND THE PATIENT¿S BLOOD GLUCOSE (BG WAS 540 MG/DL, WHILE THE DEXCOM CONTINUOUS GLUCOSE MONITOR (CGM) WAS DISPLAYING ¿SENSOR ERROR.¿ EMS TRANSPORTED THE PATIENT TO THE EMERGENCY DEPARTMENT WHERE SHE WAS ADMITTED INTO THE INTENSIVE CARE UNIT FOR TREATMENT OF DIABETIC KETOACIDOSIS (DKA). UPON ADMISSION HER BG WAS 529 MG/DL AND THE CGM STILL DISPLAYED ¿SENSOR ERROR.¿ INTRAVENOUS (IV) TREATMENT INCLUDED IV FLUIDS (ELECTROLYTES, POTASSIUM, AND MAGNESIUM) AND MEDICATIONS (INSULIN, AND THREE DOSES OF MORPHINE). THE PATIENT WAS TRANSFERRED TO A STEP-DOWN UNIT THE FOLLOWING DAY AND RECEIVED INSULIN INJECTIONS PER ROUTINE DIABETES MANAGEMENT. SHE WAS DISCHARGED HOME ON 07/07/2025 AT APPROXIMATELY 1:00 PM AND SHE WAS DOING WELL. NO CGM VALUES WERE DISPLAYED DURING THE HOSPITAL STAY. MED SAFETY TEAM ATTEMPTED TO OBTAIN ADDITIONAL DETAILS FOR THE DAY OF THE EVENT, (SYMPTOMS, CGM VALUES, ALARM AND ALERT MESSAGES) AND LEFT A MESSAGE REQUESTING A CALL BACK. TO DATE NO ADDITIONAL INFORMATION WAS RECEIVED. NO OTHER PATIENT OR EVENT DETAILS WERE AVAILABLE. DATA WAS RECEIVED BUT DOES NOT REFLECT FULL INVESTIGATION WINDOW. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #295 - 3004753838-2025-234126 SEVERE
View on MAUDE
Date of Event 2025-06-25
Patient Gender Male
Patient Age 11 YR
Device DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Not mentioned
Pump Device N/A
Event Description:
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT EXPERIENCED HYPERGLYCEMIA AND WAS DIZZY. THE CGM WAS READING 198 MG/DL AND THE BLOOD GLUCOSE READING WAS 521 MG/DL. THE PATIENT WAS TAKEN TO THE HOSPITAL, ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND TREATED WITH SALINE SOLUTION, POTASSIUM (UNKNOWN UNITS) AND THE INSULIN NOVO RAPID (UNKNOWN UNITS). THE PATIENT WAS AT THE HOSPITAL FOR A TOTAL OF 3 DAYS (1 DAY IN THE ICU). AT THE TIME OF THE REPORT THE PATIENT WAS FINE. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Report #296 - 3004753838-2025-266994 SEVERE
View on MAUDE
Date of Event 2024-09-10
Patient Gender Female
Patient Age 35 YR
Device DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (CONTINUOUS GLUCOSE MONITOR)
Closed-Loop System Yes
Pump Device N/A
Event Description:
(B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. PLEASE DISREGARD H6 HEALTH EFFECT CLINICAL CODE - 4582 NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AS THIS CODES ARE NOT APPLICABLE FOR THIS REPORT. | IT WAS REPORTED THAT SENSOR FAILURE OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM, WHICH IS OFF-LABEL USAGE OF THE DEVICE. THE DATE OF EVENT IS AN APPROXIMATION. THE PATIENT REPORTED EXPERIENCING A SENSOR FAILURE APPROXIMATELY ONE YEAR AGO, WHICH ULTIMATELY LED TO AN INTENSIVE CARE UNIT (ICU) ADMISSION. ACCORDING TO THE PATIENT, SHE RECEIVED A SENSOR FAILURE ALERT ON BOTH HER DEXCOM RECEIVER AND MOBILE APP. AT THE TIME OF THE INCIDENT, SHE DID NOT HAVE ANY REPLACEMENT SENSORS AVAILABLE, WHICH CONTRIBUTED TO HER DECISION TO SEEK EMERGENCY CARE. THE PATIENT USES THE INSULET OMNIPOD5 SYSTEM, WHICH WOULD NOT HAVE OPERATED IN MODIFIED CLOSED-LOOP MODE WITHOUT AN ACTIVE SENSOR SESSION. THE DURATION OF TIME THE SYSTEM WAS OUT OF SESSION PRIOR TO ICU ADMISSION WAS NOT SPECIFIED. ADDITIONALLY, THE GLYCEMIC CONDITION THAT NECESSITATED INTENSIVE CARE WAS NOT DESCRIBED. DURING THE CALL, THE PATIENT DID NOT PROVIDE FURTHER DETAILS ABOUT THE INCIDENT DUE TO TIME CONSTRAINTS, AS SHE NEEDED TO LEAVE FOR WORK. ALTHOUGH ADDITIONAL ATTEMPTS WERE MADE TO OBTAIN CLARIFICATION OF EVENT DETAILS, NO REPLY HAS BEEN RECEIVED. DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS CONFIRMED VIA DATA AS A SENSOR FAILURE AFTER WARM-UP. THE PROBABLE CAUSE WAS DETERMINED TO BE LOW COUNTS ABERRATION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

Data source: FDA openFDA API

MAUDE Database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

Note: Adverse event reports do not establish causation between device and event. Reports represent a subset of total device usage.

Compiled by Peter Kuhar @pkuhar