BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 24520188 · Received March 5, 2026

    Report

    Report Number
    3004753838-2026-104935
    Event Type
    Death
    Date Received
    March 5, 2026
    Date of Event
    February 15, 2026
    Report Date
    March 5, 2026
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270004864
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE REPORT WAS MADE BY A CORONER¿S OFFICE WHO REQUESTED DEXCOM FOR DATA TO ASSIST WITH THEIR ONGOING INVESTIGATION. NO CAUSE OF DEATH WAS REPORTED. IT WAS UNKNOWN WHAT THE CGM DEVICE WAS DISPLAYING AT THE TIME OF THE DEATH, BUT IT WAS STATED BY THE REPORTER THAT ¿APPARENTLY THERE WERE SENSOR ISSUES THE DAY BEFORE¿. THERE WAS NO FURTHER INFORMATION REGRADING ANY SPECIFIC MALFUNCTION OF THE DEVICE OR ANY CAUSAL RELATIONSHIP TO THE DEATH. THE REPORTER WAS UNABLE TO PROVIDE FURTHER DETAILS REGARDING THE EVENT, AND NO OTHER DETAILS WERE REPORTED. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. A REVIEW OF THE LAST WEEK OF AVAILABLE PERFORMANCE DATA FROM (B)(6) 2026 TO (B)(6) 2026 SHOWS THAT THE PATIENT EXPERIENCED LITTLE TO NO INTERRUPTIONS IN HER ESTIMATED GLUCOSE VALUES UNTIL THE EVENING OF (B)(6) 2026. UNTIL THAT POINT, THE PATIENT BREACHED THE (DISABLED) HIGH ALERT THRESHOLD OF 270 MG/DL (15.0 MMOL/L) ON FOUR SEPARATE OCCASIONS AND THE LOW ALERT THRESHOLD OF 81 MG/DL (4.5 MMOL/L) ON THREE SEPARATE OCCASIONS. MOST OF THESE BREACHES DID NOT LAST FOR EXTENDED PERIODS OF TIME, AND NONE REACHED A READING OF HIGH (GREATER THAN 400 MG/DL / 22.2 MMOL/L) OR LOW (LESS THAN 40 MG/DL / 2.2 MMOL/L). THE HIGHEST EGV RECORDED DURING THIS TIME READ 363 MG/DL (20.2 MMOL/L), WHILE THE LOWEST EGV READ 67 MG/DL (3.7 MMOL/L). ALL GLUCOSE ALERTS WERE DELIVERED BY THE APP AS INTENDED. VERY LITTLE SIGNAL LOSS WAS OBSERVED DURING THIS PERIOD AND LASTED LESS THAN 20 MINUTES THE FEW TIMES IT HAPPENED. THEREFORE, NO SIGNAL LOSS ALERTS WERE DELIVERED. NO OTHER ERRORS OR INTERRUPTIONS IN READINGS WERE OBSERVED. THEN, ON THE MORNING OF (B)(6) 2026, AT 10:17 AM, THE PATIENT STARTED A NEW SENSOR SESSION. HER ESTIMATED GLUCOSE VALUES REMAINED IN TARGET RANGE DURING THE SESSION UNTIL 9:12 PM THAT EVENING, AT WHICH POINT THE CGM ENTERED A PERIOD OF BRIEF SENSOR ISSUE. THE APP DELIVERED VISUAL NO READINGS ALERTS EVERY FIVE MINUTES FROM 9:33 PM TO 10:43 PM. THE PATIENT¿S WEARABLE SUBSEQUENTLY DISCONTINUED COMMUNICATING WITH THE APP AND A SIGNAL LOSS ALERT WAS ACKNOWLEDGED AT 6:06 PM THE FOLLOWING DAY. THE PATIENT STARTED A NEW SENSOR SESSION AT 6:14 PM ON (B)(6) 2026. THE PATIENT¿S ESTIMATED GLUCOSE VALUES READ HIGH IMMEDIATELY FOLLOWING WARM-UP AND CONTINUED TO CONSISTENTLY READ HIGH UNTIL 11:24 PM THE FOLLOWING DAY. HOWEVER, THE PATIENT DID NOT RECEIVE ANY HIGH ALERTS DURING THIS TIME AS THE HIGH ALERT WAS DISABLED. THE PATIENT¿S EGVS BEGAN TO RAPIDLY DESCEND AFTER THAT, REACHING 317 MG/DL (17.5 MMOL/L) AT 11:29 AM, 204 MG/DL (11.3 MMOL/L) AT 11:34 AM, AND 78 MG/DL (4.3 MMOL/L) AT 11:39 AM, AT WHICH POINT THE APP DELIVERED AN URGENT LOW SOON ALERT AT HALF VOLUME. AT 11:44 AM, THE PATIENT¿S EGVS REACHED LOW AND THE APP DELIVERED AN URGENT LOW ALERT AT HALF VOLUME. AT 11:49 AM, THE APP DELIVERED ANOTHER URGENT LOW ALERT AT HALF VOLUME, AGAIN WITH AN EGV OF LOW. AT 11:54 PM, THE APP DELIVERED ANOTHER URGENT LOW ALERT, THIS TIME AT FULL VOLUME, AGAIN WITH AN EGV OF LOW. THE APP CONTINUED TO DELIVER URGENT LOW ALERTS AT FULL VOLUME EVERY FIVE MINUTES UNTIL 2:34 PM, AT WHICH POINT THE CGM ENTERED A PERIOD OF BRIEF SENSOR ISSUE. THE APP DELIVERED THREE VISUAL NO READINGS ALERTS ¿ AT 2:54 PM, 2:59 PM, AND 3:04 PM. THERE IS NO VISIBLE APP DATA BEYOND THIS POINT. DEXCOM HAS REACHED OUT TO TANDEM DIABETES CARE FOR DATA ANALYSIS OF THE PATIENT¿S INSULIN PUMP ACTIVITY, BUT NO PUMP LOGS NEAR THE ALLEGED DATE OF INCIDENT WERE OBSERVED. WITHOUT PUMP PERFORMANCE DATA OR FURTHER DETAILS SURROUNDING THE PATIENT¿S PASSING, IT COULD NOT BE EXCLUDED THAT THE CGM CONTRIBUTED TO THE PATIENT¿S DEATH. THE INVESTIGATION PROBABLE CAUSE IS UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577025 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI 00386270004864

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other