Dexcom G7 Deaths

IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. DURING THE EVENT THE PATIENT WAS USING A DEXCOM G7 SENSOR IN COMBINATION WITH A TANDEM T-SLIM PUMP IN CLOSED LOOP MODE. THE REPORTER (HEALTHCARE PROVIDER) STATED THAT THE DAY BEFORE THE EVENT, THE PATIENT WAS BEEN EXPERIENCING SIGNS OF KETOACIDOSIS. THE PATIENT DID NOT SEEK MEDICAL HELP ON THAT DAY. NO CGM READING WAS REPORTED FROM THAT DAY BUT IT WAS STATED THAT THE PATIENT DID NOT TAKE ANY FINGERSTICK READINGS AT THAT TIME AND RELIED SOLELY ON THE CGM READING. ON THE DAY OF THE EVENT, THE CGM READING WAS READING 2.0 MMOL/L AND THE PATIENT WAS UNABLE TO RAISE THE LEVEL ON HER OWN. IT WAS UNKNOWN BY WHOM THEY WERE CALLED, BUT AN AMBULANCE ARRIVED TO THE PATIENT´S LOCATION, AND THE PATIENT WAS ADMINISTERED GLUCOSE (ROUTE UNKNOWN), WHICH BROUGHT THE ¿LEVEL¿ TO 5.0 MMOL/L. THERE IS NO INFORMATION REPORTED THAT A FINGERSTICK WAS TAKEN AT THAT TIME, AND THE PHYSICIAN WHO REPORTED THE EVENT STATED THAT ¿THE AMBULANCE PERSONAL SHOULD HAVE CHECKED THE CAPILLARY BLOOD GLUCOSE IN THE AMBULANCE¿. THE PATIENT WAS BROUGHT TO THE EMERGENCY DEPARTMENT. IT WAS STATED THAT ¿BEFORE BLOOD GLUCOSE COULD BE CHECKED, THE PATIENT WAS FOUND UNRESPONSIVE¿, AND ¿HAD BEEN ALONE FOR APPROXIMATELY 20 MINUTES¿. WHEN THE BLOOD GLUCOSE LEVEL WAS TESTED, THE PATIENT HAD A BLOOD GLUCOSE READING OF 80.0 MMOL/L AND WAS IN SEVERE ACIDOSIS. RESUSCITATION WAS ATTEMPTED FOR 45 MINUTES BUT WAS UNSUCCESSFUL. ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT PASSED AWAY 7 DAYS AFTER THE DAY OF 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. DEXCOM HAS REACHED OUT TO TANDEM TO REQUEST TANDEM'S DATA INVESTIGATION AND CGM DATA. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DATA INVESTIGATION IF RECEIVED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS.

(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 VIA WEB SELF-SERVICE THAT A PATIENT PASSED AWAY. THE REPORTER STATED, "MY BOYFRIEND DIED BECAUSE HIS DEXCOM WAS HOOKED TO A PUMP.". NO OTHER EVENT DETAILS WERE PROVIDED AND FOLLOW UP ATTEMPTS TO THE REPORTER FOR ADDITIONAL EVENT DETAILS WERE UNSUCCESSFUL. 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). | IT WAS REPORTED BY THE PATIENT'S SISTER THAT THE PATIENT WITH TYPE 1 DIABETES PASSED AWAY ON (B)(6) 2025. SHE DECLINED TO DISCLOSE THE CAUSE OF DEATH. SHE REPORTED CONCERNS ABOUT CGM ACCURACY ON SOCIAL MEDIA AND REITERATED THIS CONCERN ON THE PHONE CALL WITH DEXCOM ON 08/20/2025. SHE FELT THAT THE CGM MAY HAVE CONTRIBUTED TO HIS DEATH SINCE HE WAS WEARING THE G7 IN HIS ARM AND HAD THE MOBILE DEVICE NEXT TO HIM WHEN FOUND DEAD IN BED. SHE NOTED THAT THE LAST CGM READING WAS 155 MG/DL ON (B)(6) 2025, 3 DAYS PRIOR TO THE DEATH. SHE WANTED TO KNOW WHAT HAPPENED WITH THE CGM IN THE 3 DAYS BETWEEN. SHE DECLINED TO PROVIDE ANY ADDITIONAL DETAILS. NO PRODUCT HAS BEEN PROVIDED FOR INVESTIGATION. 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 HYPERGLYCEMIA. | IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. THE PATIENT¿S SPOUSE CONTACTED DEXCOM TECHNICAL SUPPORT BECAUSE SHE RECEIVED THE FAS RECEIVER LETTER. THE PATIENT¿S RECEIVER SERIAL NUMBER MATCHED THE ONE LISTED IN THE LETTER, WHICH IS WHAT PROMPTED HER TO CONTACT DEXCOM. THE PATIENT¿S SPOUSE REPORTED THAT THE PATIENT USED THE DEXCOM RECEIVER AS HIS PRIMARY CGM DISPLAY DEVICE AND IT HAD PREVIOUSLY WORKED WELL. IT WAS ALWAYS WITH HIM IN HIS POCKET, ¿LIKE A FAMILY MEMBER.¿ SHE MENTIONED THAT HE HAD DEMENTIA, AND SHE MANAGED HIS CARE. THERE WAS ALSO A RECENTLY PURCHASED IPHONE ON WHICH THE PHARMACIST GRANDSON HAD INSTALLED THE G7 APP; HOWEVER, THIS WAS NOT HIS PRIMARY DISPLAY DEVICE. THE DAUGHTER WHO LIVES NEXT DOOR WAS A FOLLOWER THAT WAY. IN THE EARLY MORNING OF THE PATIENT¿S DEATH, THE SPOUSE INDICATED SHE DID NOT RECEIVE ANY HIGH GLUCOSE ALERT FROM THE RECEIVER. SHE HEARD NO SOUND FROM EITHER THE RECEIVER IN HIS POCKET, NOR FROM THE IPHONE. LOCATION OF THE IPHONE WAS NOT RELAYED. AROUND 0200 THE DAY OF HIS DEATH, SHE HAD BEEN AWAKE SINCE SHE DOES NOT SLEEP WELL. SHE CHECKED ON HIS RECEIVER AND NOTED THE CGM READING TO BE 375 MG/DL. SHE WAS CONCERNED BECAUSE SHE HAD RECEIVED NO AUDIO FOR THE HIGH GLUCOSE ALERT. SHE RETRIEVED INSULIN AND ADMINISTERED IT TO HIM. SHE DID CHORES FOR 2-3 HOURS AND AROUND 0445-0500 SHE CHECKED ON HIM AGAIN. AT THIS TIME, HE WAS UNRESPONSIVE AND THE CGM READING ON THE RECEIVER WAS STILL REPORTEDLY 375 MG/DL. AGAIN, SHE DID NOT RECEIVE ANY HIGH GLUCOSE ALERT FROM THE RECEIVER. SHE WENT TO RETRIEVE ANOTHER INSULIN INJECTION, BUT UPON HER RETURN, THE PATIENT WAS DECEASED. SHE DID NOT HAVE AN AUTOPSY PERFORMED. A RETURN GOODS KIT HAS BEEN SENT TO THE PATIENT¿S FAMILY TO RETURN THE RECEIVER FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON DEVICE INVESTIGATION COMPLETION IF THE DEVICE IS RETURNED. A REVIEW OF THE PERFORMANCE DATA FROM THE MOBILE APP INDICATES THAT THE SENSOR SESSION STARTED AT 11:04 PM ON (B)(6) 2025. THE SESSION LASTED UNTIL 10:19 AM ON (B)(6) 2025. ACCORDING TO THE ALERTS SCHEDULE THE HIGH ALERT AND THE SENSOR ERROR (NO READINGS) ALERTS WERE SET TO MATCH PHONE SETTINGS. ON (B)(6) 2025 AT 11:34 PM THE USER RECEIVED A HIGH GLUCOSE ALERT WHICH REPEATED EVERY 5 MINUTES UNTIL ACKNOWLEDGED AT 12:03 PM ON (B)(6) 2025. ON (B)(6) 2025 THE USERS ESTIMATED GLUCOSE VALUES (EGVS) WERE ABOVE THEIR TARGET RANGE UP UNTIL 5:34 PM WHEN THEY DROPPED BELOW 350 MG/DL. AT 8:04 PM THE EGVS REACHED 350 MG/DL AND THE HIGH GLUCOSE ALERT OCCURRED AGAIN. THIS ALERT REPEATED EVERY 5 MINUTES UNTIL AUTO CLEARED AT 12:19 AM ON (B)(6) 2025. ON (B)(6) 2025 AT 2:29 AM THE USERS EGVS REACHED 350 MG/DL AND THE USER RECEIVED ANOTHER HIGH GLUCOSE ALERT. FROM 2:34 AM THROUGH 4:29 AM THE USERS EGVS CONTINUED TO RISE UNTIL REACHING HIGH (>400 MG/DL) AT 4:34 AM. THE EGVS THEN REMAINED HIGH (>400 MG/DL) AND THE ALERT REPEATED EVERY 5 MINUTES UNTIL 9:39 AM WHEN THE SENSOR BEGAN TO EXPERIENCE BRIEF SENSOR ISSUES. AT 10:00 AM A NO READING ALERT OCCURRED, WHICH REPEATED EVERY 5 MINUTES. THE BRIEF SENSOR ISSUES CONTINUED UNTIL 11:04 AM. SUBSEQUENTLY, SENSOR SESSION DATA ENDED FOR AN UNDISCERNIBLE REASON. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION IS REQUIRED. | (B)(4).

THE REPORTER STATES HER HUSBAND PASSED ON (B)(6) 2025. SHE STATES HER HUSBAND HAD MULTIPLE DEXCOM SENSORS THAT WOULD ONLY LAST ONE TO TWO DAYS BEFORE HAVING CONNECTIVITY ISSUES. AT THE TIME OF HIS PASSING, THE PATIENT WAS WEARING A DEXCOM SENSOR THAT WAS NOT SHOWING ANY READINGS. NO ALERT WENT OFF TO NOTIFY THEM. THE SENSOR READING ON HIS PHONE LATER SAID "EXPIRED" AND NOTED TO REPLACE IT. THE REPORTER RECEIVED A LETTER FROM DEXCOM IN JULY STATING THAT RECEIVERS ARE HAVING ISSUES. THEN, THEY RECEIVED ANOTHER LETTER LATER STATING THAT HER HUSBANDS SENSOR MAY HAVE BEEN PART OF A DEFECTIVE BATCH.

(B)(4). H6 HEALTH EFFECT - CLINICAL CODE - E0115 ENCEPHALOPATHY. | IT WAS REPORTED VIA MAUDE REPORT NUMBER MW5174584 THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. THE RELATIONSHIP OF THE REPORTER TO THE PATIENT WAS NOT PROVIDED. ACCORDING TO THE REPORT, THE PATIENT USED G7 RECEIVER AND WAS FOUND UNRESPONSIVE ON (B)(6) 2025. SHE WAS AIRLIFTED TO A HOSPITAL. SHE HAD SUFFERED SEIZURES FROM HYPOGLYCEMIC SHOCK AND REPORTEDLY DID NOT RECOVER FROM THE RESULTING BRAIN DAMAGED AND DIED SOMETIME LATER. BEFORE HER DEATH, SHE UNDERWENT TESTING WHICH SHOWED ONGOING SEIZURES. ACCORDING TO THE REPORT, HER GLUCOSE WAS UNDER 40 MG/DL FOR 13 HOURS BY THE TIME OF HER DISCOVERY. THE CAUSE OF DEATH WAS REPORTED TO BE METABOLIC ENCEPHALOPATHY DUE TO HYPOGLYCEMIA. AFTER HER DEATH, A LETTER FROM DEXCOM WAS RECEIVED NOTIFYING ABOUT THE RECEIVER ALERT PROBLEM. THE REPORT NOTES THAT THE PATIENT LIVED ALONE AND DEPENDED ON GLUCOSE ALERTS FROM THE RECEIVER. ATTEMPTS TO CONTACT THE REPORTER FOR ADDITIONAL DETAILS BY PHONE WERE UNSUCCESSFUL. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. A RETURN GOODS KIT HAS BEEN SENT TO THE PATIENT¿S FAMILY TO RETURN THE ALLEGED RECEIVER FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON DEVICE INVESTIGATION COMPLETION IF THE DEVICE IS RETURNED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). | SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION IS REQUIRED.

(B)(6) USED THE DEXCOM G7. SHE USED THE G7 RECEIVER PART NUMBER MT26403-0 TO MONITOR AND TRACK HER GLUCOSE LEVELS. ON SUNDAY, (B)(6) 2025 WE FOUND HER UNRESPONSIVE. SHE WAS AIRLIFTED TO (B)(6) HOSPITAL ((B)(6)) IN (B)(6). SHE HAD SUFFERED SEIZURES WHICH LEFT HER IN THE CONDITION WE FOUND HER IN. SHE NEVER RESPONDED OR RECOVERED FROM THE BRAIN DAMAGE CAUSED BY THE SEIZURES AND PASSED AWAY ON (B)(6) 2025. THE SEIZURES WERE CAUSED BY HYPOGLYCEMIA. HER GLUCOSE WAS UNDER 40 FOR OVER 13 HOURS ONCE WE FOUND HER. HER CAUSE OF DEATH WAS METABOLIC ENCEPHALOPATHY DUE TO HYPOGLYCEMIA. AFTER SHE HAD PASSED AWAY, A LETTER FROM (B)(4) DATED (B)(6) 2025, WAS RECEIVED STATING ON (B)(6) 2025 (4 DAYS BEFORE (B)(6) HYPOGLYCEMIC EVENT OCCURRED) DEXCOM HAD NOTIFIED THEM THAT CERTAIN PART NUMBERS OF THE G7 RECEIVERS MAY EXPERIENCE AN ISSUE WHERE THE ALARM/ALERT MAY NOT PROVIDE AUDIO OUTPUT. PAMELA LIVED ALONE AND DEPENDED ON HER RECEIVER TO ALERT HER IF HER GLUCOSE WAS OUT OF RANGE. THERE WERE MANY TESTS RAN ON (B)(6) TO DETERMINE WHAT HAD CAUSED HER ISSUE. SHE HAD HER 1ST MAGNETIC RESONANCE IMAGING OF THE BRAIN SHOWING DAMAGE EITHER LATE (B)(6) 2025, OR IN THE EARLY MORNING HOURS OF (B)(6) 2025. SHE WAS THEN HOOKED UP TO THE ELECTROENCEPHALOGRAM TO DETERMINE IF SEIZURES WERE STILL OCCURRING. ANOTHER MRI WAS COMPLETED SOME DAYS AFTER THAT STILL IN (B)(6) 2025 STILL SHOWING THE DAMAGE. THE ELECTROENCEPHALOGRAM PICKED UP MORE SEIZURES AND THEN THE SLOW BRAIN ACTIVITY.

IT WAS REPORTED BY INSULET THAT AN UNKNOWN PATIENT EXPERIENCED BRAIN DEATH FOLLOWING COMA WITH ALLEGATION OF UNSPECIFIED DEXCOM MALFUNCTION. THE REPORT WAS MADE BY AN UNIDENTIFIED INDIVIDUAL ON A SOCIAL MEDIA POST TO INSULET. INSULET AND DEXCOM WERE UNABLE TO DETERMINE THE PATIENT REFERENCED THE COMPLAINT. THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION. 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).

IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. THE PATIENT'S SPOUSE INITIALLY CALLED DUE TO RECEIVING A LETTER FOR THE RECEIVER RECALL. THE ISSUE WITH THE DEVICE OCCURRED ON (B)(6) 2025 AROUND 2:30 AM. THE SPOUSE WOKE UP AND CHECKED ON THE PATIENT BUT SHE COULDN'T WAKE HIM. UPON CHECKING HIS MONITOR, DEXCOM SHOWED, 54MGDL. THE SPOUSE SAID SHE DIDN'T HEAR ANY ALARM THAT HE WAS LOW. SHE DID NOT CHECK THE BG. IT NEVER ALERTED THEM. SHE TRIED TO GIVE JUICE, BUT HE WAS UNRESPONSIVE. SHE THEN CALLED AN AMBULANCE DESPITE THE PATIENT BEING ON PALLIATIVE CARE. THEY TOOK THE PATIENT TO THE HOSPITAL. HE WAS SEVERELY HYPOGLYCEMIC. THEY PUT HIM ON IV, GOT HIS SUGAR BACK UP. HE WAS DISCHARGED HOME AND CONTINUED TO RECEIVE PALLIATIVE CARE. HE DID RECOVER FROM THE HYPOGLYCEMIC EPISODE BUT PASSED 2 DAYS LATER. THE SPOUSE ALLEGED THAT THE ABSENCE OF ALERT DID CONTRIBUTE TO HIS DEATH. SHE STATED SHE FELT HE'D STILL BE ALIVE HAD SHE RECEIVED THE LOW GLUCOSE ALERT FROM THE RECEIVER AND HAD NOT HAD THE MISSED HYPOGLYCEMIC EPISODE. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. A RETURN GOODS KIT HAS BEEN SENT TO THE PATIENT¿S FAMILY TO RETURN THE ALLEGED RECEIVER FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON DEVICE INVESTIGATION COMPLETION IF THE DEVICE IS RETURNED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4).

(B)(4). | IT WAS REPORTED BY A HEALTHCARE PROVIDER VIA MAUDE (MW5164857) AND BY THE FOOD AND DRUG ADMINISTRATION THAT A PATIENT PASSED AWAY ON (B)(6) 2025. THE MAUDE REPORT STATES THAT THE PATIENT WAS SUPPOSED TO COME TO THE HEALTHCARE PROVIDER (HCP) OFFICE BUT CANCELLED AND DID NOT RESCHEDULE. THE DATE OF DEATH WAS NOT PROVIDED. THERE IS NO REPORTER INFORMATION TO GATHER ADDITIONAL INFORMATION AS THE HCP DID NOT WISH TO FOLLOW UP AND THERE IS NO PATIENT INFORMATION AVAILABLE. NO DATA OR PRODUCT WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED.

IT WAS REPORTED BY AN ADMINISTRATOR THAT THE PATIENT PASSED AWAY WHILE USING THE DEXCOM G7 CONTINUOUS GLUCOSE MONITOR SYSTEM. ACCORDING TO THE REPORTER, PRIOR TO THE PATIENT'S DEATH, THE PATIENT HAD EXPRESSED CONCERNS TO HER FRIENDS AND FAMILY THAT THE CGM HAD BEEN PROVIDING INCORRECT READINGS. WHETHER AND HOW THESE INACCURATE READINGS WERE RELATED TO THE PATIENT'S DEATH, HOWEVER, WERE NOT SPECIFIED, NOR WERE ANY OTHER DETAILS PROVIDED. DEXCOM REPRESENTATIVES HAVE ATTEMPTED TO FOLLOW UP WITH BOTH THE REPORTER AND THE REPORTING ORGANIZATION MULTIPLE TIMES FOR FURTHER DETAILS, BUT WERE TOLD THAT IT WAS AN ONGOING INVESTIGATION, AND NO NEW INFORMATION REGARDING THE EVENT, NOR PATIENT INFORMATION WERE RECEIVED. NO DATA WAS RETURNED FOR THE ALLEGED DATE OF INCIDENT ON (B)(6) 2024. WITHOUT PERFORMANCE DATA TO INVESTIGATE, THE COMPLAINT OF DISCREPANCIES REMAINS UNCONFIRMED. THE PROBABLE CAUSE OF THE ALLEGED EVENT COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4).

(B)(4). B5 DESCRIBE EVENT OR PROBLEM - ADDITIONAL. H2 ADDITIONAL INFORMATION. H6 INVESTIGATION FINDINGS - ADDITIONAL. H6 INVESTIGATION CONCLUSION - ADDITIONAL. | DATA WAS PROVIDED FOR INVESTIGATION. SIGNAL LOSS OVER ONE HOUR WAS FOUND IN CONNECTION TO THE ALLEGATION. CONFIRMATION OF THE COMPLAINT AND THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. | (B)(4). H2 CORRECTION. H6 MEDICAL DEVICE PROBLEM CODE - CORRECTION. | SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED. | SUBSEQUENT TO THE INITIAL MDR, A FURTHER REVIEW OF THE DATA LOGS WERE PERFORMED. A REVIEW OF THE DATA LOGS INDICATES THAT THE USER WORE THE LAST SENSOR FOR NINE DAYS. THE LAST SENSOR SESSION STARTED ON (B)(6) 2024 AT 09:28 AM, WITH THE FIRST ESTIMATED GLUCOSE VALUE (EGV) OF 184 MG/DL AT 09:53 AM. DURING THIS SENSOR SESSION, THE PATIENT¿S EGVS BREACHED THE USER-SET HIGH THRESHOLD NINE TIMES AND THE USER-SET LOW THRESHOLD THREE TIMES. ON (B)(6) 2024, THE APP EXPERIENCED INTERMITTENT SIGNAL LOSS UNDER 15 MINUTES, ONE INSTANCE OF SIGNAL LOSS OVER AN HOUR, AND THE PATIENT¿S EGVS WERE HIGH (OVER 400 MG/DL) FROM 5:13 AM TO 10:58 AM. ON (B)(6) 2024, THE PATIENT¿S EGVS REMAINED WITHIN TARGET RANGE UNTIL 02:13 AM, WHEN EGVS ROSE ABOVE THE USER-SET HIGH ALERT THRESHOLD (240 MG/DL) WITH AN EGV OF 241 MG/DL. THE APP DELIVERED A HIGH ALERT WITH 0 PERCENT VOLUME AS THE HIGH ALERT WAS SET TO VIBRATE ONLY. THE PATIENT¿S EGVS RETURNED WITHIN TARGET RANGE UNTIL THEY ROSE ABOVE THE HIGH ALERT THRESHOLD AT 3:18 AM WITH AN EGV OF 243 MG/DL. THE APP DELIVERED HIGH ALERTS (VIBRATE ONLY) AND RISE RATE ALERTS (45 PERCENT VOLUME) UNTIL THESE ALERTS WERE ACKNOWLEDGED AT 4:19 AM. THE PATIENT¿S EGVS REMAINED ABOVE THE HIGH THRESHOLD, BUT THE APP DID NOT DELIVER ANY MORE HIGH ALERTS BECAUSE THE SNOOZE FEATURE WAS DISABLED. THE APP DID, HOWEVER, DELIVER RISE RATE ALERTS AT 45 PERCENT VOLUME AT 05:54 AM AND 05:59 AM. AFTER FIVE MINUTES OF TEMPORARY SENSOR ERROR AT 06:48 AM, THE APP DELIVERED HIGH ALERTS (VIBRATE ONLY) FROM 6:54 AM UNTIL THIS ALERT WAS ACKNOWLEDGED AT 10:01 AM. THE PATIENT¿S EGVS REMAINED ABOVE THE HIGH THRESHOLD UNTIL 01:14 PM, BUT THE APP DID NOT DELIVER ANY MORE HIGH ALERTS BECAUSE THE SNOOZE FEATURE WAS DISABLED. THE PATIENT¿S EGVS RETURNED WITHIN TARGET RANGE FROM 01:19 PM TO 04:29 PM WITH EGVS DROPPING FROM 226 MG/DL TO 99 MG/DL. PRIOR TO SIGNAL LOSS, THE LAST EGV WAS 99 MG/DL WITH A FLAT TREND ARROW. THE APP EXPERIENCED SIGNAL LOSS FROM 04:33 PM TO 07:48 PM. THE SIGNAL LOSS ALERT HAD BEEN DISABLED BY THE USER, BUT A VISUAL ICON WOULD PRESENT. AT 04:33 PM, THE FIRST BACKFILLED DATA POINT WAS TEMPORARY SENSOR FAILURE AT ABOUT 60 MG/DL. AT 04:48 PM, BACKFILLED DATA SHOWS THE PATIENT¿S EGVS WERE LOW (BELOW 40 MG/DL). AT 07:49 PM, WHEN SIGNAL RETURNED, THE PATIENTS EGVS WERE STILL LOW (BELOW 40 MG/DL) AND THE APP DELIVERED AN URGENT LOW ALERT WITH 0 PERCENT VOLUME BECAUSE THE PATIENT SETTING WAS FOR VIBRATE. AT 07:54 PM, THE APP DELIVERED A SECOND URGENT LOW ALERT, THIS TIME AT 100 PERCENT VOLUME THROUGH THE MOBILE PHONE EAR SPEAKER. FROM 08:04 PM TO 08:19 PM, THE APP DELIVERED URGENT LOW ALERTS AT 100 PERCENT VOLUME THROUGH AN EXTERNAL BLUETOOTH DEVICE. AT 08:18 PM, THE APP EXPERIENCED TEMPORARY SENSOR ERROR. NO DEVICE PERFORMANCE DATA WAS RECORDED IN THE DATA LOGS AFTER THIS TIME. THE ALLEGATION OF NO SENSOR READINGS OR ALERTS IS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE POTENTIAL PATIENT MISUSE AS THE SIGNAL LOSS ALERT WAS DISABLED. THE DEVICE FUNCTIONED WITHIN SPECIFICATIONS AND PATIENT SETTINGS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4). | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED BY THE PATIENT'S DAUGHTER THAT THE PATIENT HAD PASSED ON AWAY (B)(6) 2024. THE REPORTER CONTACTED DEXCOM TO INQUIRE IF DEXCOM HAD MORE DETAILS ABOUT THE PATIENT'S CGM READINGS DURING A PERIOD OF SENSOR ERROR PRIOR TO THE PATIENT'S PASSING. THE REPORTER NOTED A BREAK IN THE CGM READINGS BETWEEN 4:00PM-5:00PM THE DAY OF THE PATIENT'S DEATH. THE REPORTER INQUIRED WHY THE DEXCOM WAS NOT READING FOR A CERTAIN AMOUNT OF TIME. SHE MENTIONED THAT SHE COULD SEE THE ALERTS AND IT NEVER ALERTED THE PATIENT THAT THE SENSOR WAS OFF/NOT READING AND DID NOT ALERT HER TO HYPOGLYCEMIA. WHEN CGM READINGS RETURNED, THE VALUE WAS REPORTEDLY "LOW", BUT SHE HAD REPORTEDLY ALREADY PASSED AWAY BY THAT POINT WHEN SHE RECEIVED THAT ALERT. THE REPORTER INQUIRED HOW LONG THE PATIENT HAD BEEN IN SENSOR ERROR PRIOR TO THE "LOW" CGM READING. THE PATIENT WAS NOTED TO HAVE ATTEMPTED TO TREAT HERSELF WITH PEANUT BUTTER. THE PATIENT'S CAUSE OF DEATH WAS BELIEVED TO BE HYPOGLYCEMIA, ALTHOUGH NO AUTOPSY WAS PERFORMED. THE REPORTER ALLUDED TO USING THE FOLLOW APP AND STATED THAT NO ONE WAS ALERTED AFTER THE CGM READING WAS 100 MG/DL . THE REPORTER NOTED THAT NO ONE WAS ALERTED TO THE SENSOR ERROR AND ALSO NO ONE WAS ALERTED TO THE HYPOGLYCEMIA. THE REPORTER NOTED THAT SHE WAS NOT ALERTED UNTIL THE CGM READING WAS 39 MG/DL AND THE PATIENT HAD ALREADY PASSED AWAY. THE REPORTER NOTED AN ABSENCE OF AN ALERT FOR 15 MINUTES WHEN REVIEWING THE PATIENT'S APP. THERE WAS REPORTEDLY NO FURTHER INFORMATION SINCE THE CALLER WANTED TO CHECK IF THE DEXCOM SYSTEM COULD HAVE RECORDED THE SENSOR READINGS DURING THE TIME FRAME. NO PRODUCT WAS PROVIDED FOR INVESTIGATION. DATA WAS RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

SUBSEQUENT TO THE INITIAL MDR, DATA INVESTIGATION WAS COMPLETED. NO PERFORMANCE DATA WAS FOUND IN THE DEXCOM CLOUD FOR THIS USER EVENT. BASED ON THE CGM PERFORMANCE PROVIDED BY TANDEM, THE FOLLOWING SUMMARIZES THE CGM DATA FOR THE TIME OF INTEREST. THE BACKFILL CGM VALUES, WHICH OCCUR DURING TEMPORARY SIGNAL LOSS EVENTS, WERE NOT PROVIDED IN THE TANDEM REPORT, AND THEREFORE HAVE BEEN EXCLUDED FROM THE DATA. FOR GLUCOSE ALERTS AND TECHNICAL ALERTS, THE AUDIO VOLUME WAS NOT AVAILABLE. CORRESPONDENCE FROM TANDEM INDICATES THAT AUDIO ALERTS FOR THE PUMP STARTED OUT AS VIBRATION AND PROGRESSED TO 50 PERCENT THEN 100 PERCENT AUDIO VOLUME. ON (B)(6) 2024 AT (B)(6) A NEW SENSOR SESSION WAS STARTED BY THE USER. AT (B)(6) , THE WARMUP PERIOD COMPLETED AND THE FIRST ESTIMATED GLUCOSE VALUE (EGV) OF 160 MG/DL WAS LOGGED. BETWEEN(B)(6) AND (B)(6) THE USERS EGVS FLUCTUATED BETWEEN 160 MG/DL AND 82 MG/DL BUT REMAINED WITHIN TARGET RANGE. AT(B)(6) THE USER EGVS HIT 73 MG/DL AND THE USER RECEIVED A LOW GLUCOSE ALERT WHICH WAS ACKNOWLEDGED. AT (B)(6) , THE USER EGVS HIT 53 MG/DL AND THE USER RECEIVED AN URGENT LOW GLUCOSE ALERT WHICH WAS ACKNOWLEDGED. AT (B)(6) THE USER EGVS HIT 66 MG/DL AND THE USER RECEIVED A LOW GLUCOSE ALERT WHICH WAS ACKNOWLEDGED. AT (B)(6) THE USER EGVS HIT 53 MG/DL AND THE USER RECEIVED AN URGENT LOW GLUCOSE ALERT WHICH WAS NOT ACKNOWLEDGED. ON (B)(6) 2024 BETWEEN (B)(6) AND (B)(6) , THE USER¿S EGVS REMAINED BELOW TARGET RANGE AND THE USER RECEIVED SEVERAL LOW GLUCOSE AND URGENT LOW ALERTS AS THE EGVS FLUCTUATED BETWEEN 49 MG/DL AND 77 MG/DL. NONE OF THESE ALERTS WERE ACKNOWLEDGED BY THE USER. AT (B)(6) THE ALERTS CLEARED AS THE EGVS ROSE PAST THE LOW THRESHOLD AND CONTINUED TO RISE. AT(B)(6) , THE USERS EGVS ROSE ABOVE THE HIGH THRESHOLD TO 202 MG/DL AND THE USER RECEIVED A HIGH GLUCOSE ALERT. THIS ALERT WAS ACKNOWLEDGED BY THE USER AT (B)(6) . BETWEEN (B)(6) AND (B)(6) THE EGVS CONTINUED TO RISE UNTIL REACHING A MAXIMUM OF 295 MG/DL AT (B)(6) . AT THAT POINT, THE EGVS BEGAN TO DECREASE. BETWEEN(B)(6) AND(B)(6) THE USERS EGVS DECREASED FROM 286 MG/DL TO 205 MG/DL. AT (B)(6) , THE HIGH ALERT WAS CLEARED WHEN THE EGVS DECREASED BELOW THE HIGH THRESHOLD. THE USERS EGVS THEN REMAINED WITHIN IN TARGET (199 MG/DL ¿ 113 MG/DL) FOR THE REMAINDER OF THE DAY. ON (B)(6) 2024. BETWEEN (B)(6) AND(B)(6) THE USERS EGVS REMAINED WITHIN TARGET (110 MG/DL ¿ 194 MG/DL). AT (B)(6) , THE USER¿S EGVS HIT 200 MG/DL BRIEFLY AND THE USER RECEIVED A HIGH GLUCOSE ALERT. THIS ALERT WAS CLEARED 5 MINUTES LATER WHEN THE EGVS FELL BELOW THE HIGH THRESHOLD. BETWEEN (B)(6) AND (B)(6) THE USERS EGVS CONTINUED TO DECREASE AND REMAINED WITHIN TARGET (199 MG/DL ¿ 81 MG/DL). AT (B)(6) , THE USERS EGVS HIT 78 MG/DL BRIEFLY AND THE USER RECEIVED A LOW GLUCOSE ALERT. THIS ALERT WAS CLEARED WHEN THE EGVS ROSE ABOVE THE LOW THRESHOLD. BETWEEN (B)(6) AND (B)(6) USERS EGVS REMAINED WITHIN TARGET RANGE (81 MG/DL ¿ 129 MG/DL). AT(B)(6) , IT WAS NOTED THAT THE USER ATTEMPTED TO LOAD AN INSULIN CARTRIDGE INTO THE PUMP AND THERE WERE NOTED TO BE FOUR INSTANCES OF TUBE FILLINGS. AFTERWARD, THE PATIENT SUSPENDED AND RESUMED THE INSULIN DELIVERY MULTIPLE TIMES AND RESUMED IT FOR THE FINAL TIME AT (B)(6) . AT (B)(6) , THE USER¿S EGVS HIT 80 MG/DL AND THE USER RECEIVED A LOW GLUCOSE ALERT. THIS ALERT WAS ACKNOWLEDGED BY THE USER. AT (B)(6) , THE USER¿S EGVS HIT 51 MG/DL AND THE USER RECEIVED AN URGENT LOW ALERT. THIS ALERT WAS ACKNOWLEDGED BY THE USER. THE TANDEM REPORT ALSO ADDS THAT THE CGM READINGS MOMENTARILY RECOVERED REACHING A HIGH OF 54 MG/DL AT (B)(6) BEFORE FALLING AGAIN WITH THE REMAINDER OF CGM READINGS BEING BELOW 54 MG/DL. CONTROL-IQ REDUCED BASAL DELIVERIES APPROPRIATELY WHILE CGM READINGS WERE AVAILABLE. THE FINAL AVAILABLE READINGS WERE AT(B)(6) DISPLAYING ON THE PUMP SCREEN ¿LOW¿. AT (B)(6) , CGM FIXED LOW ALERT WAS CLEARED. AT (B)(6) , PUMP CONTROL MODE WAS CHANGED TO OPEN FROM CLOSED LOOP. AT (B)(6) , ALERT FOR ¿CONTROL-IQ LOW¿ WAS CLEARED. AT (B)(6) , BASAL DELIVERIES WERE CHANGED TO 0.3 U/HR. AT (B)(6) , NO READINGS ALERT WAS ACTIVATED. AT(B)(6) , NO READINGS ALERT WAS CLEARED. AT (B)(6) , A CGM SENSOR FAILED ALERT ACTIVATED. CONFIRMATION OF THE ALLEGATION AND PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. | (B)(4) . | IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. THE PATIENT WAS STARTED ON A TANDEM PUMP AND DEXCOM G7 SENSOR ON MONDAY, (B)(6)2024. PRIOR TO THAT, SHE HAD USED A MEDTRONIC PUMP SYSTEM. ON WEDNESDAY, (B)(6) 2024 AT 6:00PM HER SON RECEIVED A LOW NOTIFICATION FOR A CGM VALUE AROUND 50 MG/DL ON HIS DEXCOM FOLLOW APP. AFTER THE URGENT LOW ALERT, HE DID NOT RECEIVE ANY FURTHER NOTIFICATIONS. THE SON REPORTEDLY LIVES OUT OF STATE AND DID NOT CALL THE PATIENT OR HAVE HER CHECKED ON UNTIL THE FOLLOWING MORNING. ON (B)(6) 2024, THE SON CALLED A NEIGHBOR TO CHECK ON HER. SHE WAS ALLEGEDLY FOUND UNRESPONSIVE WITH EVIDENCE OF SEIZING. SHE WAS TRANSPORTED TO THE HOSPITAL WHERE SHE WAS PLACED ON END-OF-LIFE CARE AND PASSED AWAY ON (B)(6) 2024. FOLLOW UP CONTACT WAS MADE WITH THE INPATIENT PHYSICIAN ASSISTANT DIABETES PROVIDER ON (B)(6) 2024. THE PA NOTED THAT STROKE HAD BEEN RULED OUT; HOWEVER, IT WAS REPORTED THAT THE PATIENT SUSTAINED BRAIN DAMAGE. THE PA REPORTED THAT SHE REVIEWED THE TANDEM PUMP DOWNLOAD AND NOTED THAT THE PATIENT HAD RECEIVED "CGM UNAVAILABLE" ALERTS A FEW HOURS BEFORE RECEIVING THE URGENT LOW ALERT. THE PA DESCRIBED THAT THE PUMP SUSPENDED INSULIN DELIVERY WITH THE URGENT LOW; HOWEVER, THE SENSOR EVENTUALLY FAILED AT 9:00PM ON (B)(6) 2024 CAUSING THE PUMP TO REVERT TO AN OPEN LOOP INSULIN DELIVERY. THERE WAS REPORTEDLY EVIDENCE OF BUTTON PUSHING ON THE PUMP AND A MANUAL STOP. THE PA SUSPECTED USER ERROR. THE REPORT NOTES THE PATIENT WAS REPORTED TO HAVE BEEN SHOWING SIGNS OF COGNITIVE DECLINE OVER THE PAST YEAR. THE FAMILY REQUESTED AN INVESTIGATION OF THE CGM. ATTEMPTS BY DEXCOM TO CONTACT THE SON FOR MORE DETAILS ABOUT THE EVENT AND TO OBTAIN AN ADDRESS TO SET UP RETURN OF THE CGM FOR INVESTIGATION WERE UNSUCCESSFUL. TANDEM PUMP DATA INVESTIGATION IS IN PROGRESS AND WILL PROVIDE ADDITIONAL INFORMATION WHEN INVESTIGATION BY TANDEM IS COMPLETE. NO CGM 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.

IT WAS REPORTED VIA MAUDE (MW5173056) AND FOLLOW UP CONTACT WITH THE PATIENT'S PARENT THAT THE PATIENT PASSED AWAY. THE PATIENT'S PARENT NOTED THAT SHE REPORTED THIS VIA MAUDE AFTER RECEIVING THE RECEIVER FIELD ACTION LETTER IN THE MAIL AND NOTING THAT THE SERIAL NUMBER ON THE LETTER MATCHED THE PATIENT'S RECEIVER. THE PATIENT'S PARENT REPORTED THAT THE PATIENT USED AN INSULIN PUMP BUT DID NOT KNOW WHICH ONE AND BELIEVED IT TO HAVE BEEN IN MODIFIED CLOSED LOOP. USE OF AN INSULIN PUMP DURING THE EVENT IS NOT CONFIRMED AND NO FURTHER DETAILS WERE AVAILABLE. THE PATIENT HAD REPORTEDLY BEEN SICK AND VOMITING. HE WAS NOTED TO HAVE BEEN ALONE IN HIS APARTMENT WHEN HE WAS FOUND AFTER BEING DECEASED 3 DAYS. THE PARENT REPORTED FINDING THE DEXCOM RECEIVER NEXT TO HIM, BUT COULD NOT RECALL ANY CGM READINGS, ALERTS, OR ALARMS FROM THE DEVICE AT THAT TIME. AN AUTOPSY NOTED THAT HE HAD DIED FROM DIABETIC KETOACIDOSIS (DKA). THE PATIENT HAD BEEN EVALUATED AND TREATED IN THE EMERGENCY DEPARTMENT FOR SYMPTOMATIC HYPERGLYCEMIA DUE TO INACCURACIES ON THE CGM APPROXIMATELY 8 MONTHS PRIOR TO HIS DEATH. THIS PREVIOUS ISSUE COUPLED WITH THE LETTER SHE RECEIVED MADE THE PARENT SUSPICIOUS THAT THE PATIENT'S DEATH WAS THE RESULT OF A DEXCOM MALFUNCTION, ALTHOUGH SHE COULD NOT SPECIFY WHAT SHE BELIEVED THE PROBLEM TO BE. THE PATIENT'S PARENT NOTED THAT SHE HAD THE PATIENT'S RECEIVER IN HER POSSESSION AND WOULD CONSIDER RETURNING IT FOR INVESTIGATION. DEXCOM HAS SENT THE PATIENT'S MOTHER A RETURN GOODS AUTHORIZATION TO SEND PRODUCT IN FOR INVESTIGATION. IF PRODUCT IS RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED UPON INVESTIGATION COMPLETION. 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).

(B)(4). B5: DESCRIBE EVENT OR PROBLEM - ADDITIONAL. H2: ADDITIONAL INFORMATION. H6: INVESTIGATION FINDINGS. H6: INVESTIGATION CONCLUSION. | DATA WAS PROVIDED FOR EVALUATION. THE USER STARTED THEIR SENSOR SESSION AT 06:04 AM ON (B)(6) 2025 AND THE LAST KNOWN READING OF THE SENSOR WAS AT 06:14 PM ON (B)(6) 2025. ON (B)(6) 2025 AT 9:03 AM THE PATIENT HAD THEIR USER SETTINGS SET TO SOUND FOR LOW AND URGENT LOW ALERTS. HOWEVER, AT 06:13 PM ON (B)(6) 2025, THE USER UPDATED ALERT SETTINGS TO ALSO DISABLE THE LOW ALERTS AND SET THE URGENT LOW ALERT TO VIBRATE ONLY. THE USER¿S ALERT SETTINGS INDICATE THAT MOST OF THE ALERTS WERE DISABLED AT 6:13 PM. ADDITIONALLY, AT 6:14 PM BLUETOOTH WAS TURNED OFF. DEXCOM WAS UNABLE TO DETERMINE WHY THE BLUETOOTH WAS DISABLED. THE APPLICATION ISSUED THE FOLLOWING ALERT TO THE USER AFTER THE BLUETOOTH WAS TURNED OFF: "LE BLUETOOTH DU TÉLÉPHONE EST DÉSACTIVÉ." DUE TO THE BLUETOOTH BEING DISABLED NO FURTHER ESTIMATED GLUCOSE VALUE (EGV) DATA TO THE DISPLAY DEVICE IS PROVIDED BEYOND 6:14 PM AND THEREFORE WOULD NOT TRIGGER ANY ALERTS RELATED TO EGV (HIGH, LOW, URGENT LOW, ETC). THE ALLEGATION OF A DEXCOM SYSTEM ISSUE WAS UNDETERMINED. HOWEVER, DATA SHOWS ALERTS WERE DISABLED, SET TO VIBRATE ONLY, AND BLUETOOTH OFF RELATED TO THE ALLEGED INCIDENT. THE PROBABLE CAUSE COULD NOT BE DETERMINED. | (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. | IT WAS REPORTED VIA EMAIL THAT THE PATIENT PASSED AWAY. ACCORDING TO THE EMAIL, THE PATIENT WITH TYPE 1 DIABETES PASSED AWAY AFTER BEING IN A COMA ON (B)(6) 2025. ON(B)(6) 2025, SHE WAS STILL WEARING HER SENSOR. WHEN THE DEXCOM MOBILE APPLICATION DATA WAS REVIEWED BY POLICE INVESTIGATOR, DATA WAS NO LONGER SEEN RECORDED AFTER (B)(6) 2025 AT 1800. IN ADDITION, IT WAS REPORTED THAT THERE DID NOT SEEM TO HAVE BEEN AN ALERT AROUND 1800 WHEN THE SENSOR STOPPED SENDING DATA AND THE PATIENT WAS VERY LOW IN BLOOD SUGAR. NO FURTHER EVENT INFORMATION WAS PROVIDED. 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. | SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION IS REQUIRED. | (B)(4). E1 REPORTER INFORMATION - ADDITIONAL. H2 ADDITIONAL INFORMATION.

PATIENT PASSED AWAY AND WAS SUPPOSED TO COME TO OFFICE IN DEC BUT CANCELLED THEN DIDN'T RESCHEDULE. NO ADDITIONAL INFORMATION REPORTED OR AVAILABLE REGARDING THIS EVENT. PAE REPORTED BY HCP, WHO DOES NOT CONSENT TO FOLLOW UP. CAUSE AND DATE OF DEATH NOT PROVIDED. (B)(4).