BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 25245802 · Received May 21, 2026

    Report

    Report Number
    3004753838-2026-156992
    Event Type
    Death
    Date Received
    May 21, 2026
    Date of Event
    January 1, 2025
    Report Date
    May 21, 2026
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA.

    Description of Event or Problem · 0

    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 REPORTER STATED THAT THE PATIENT WAS NOT FEELING WELL. THE PATIENT¿S CGM WAS ALERTING HIM TO AN UNSPECIFIED LOW VALUE. THE PATIENT¿S WIFE REPORTED CHANGING THE PATIENT¿S SENSOR 2-3 TIMES, HOWEVER, EACH SENSOR CONTINUED TO SHOW UNSPECIFIED LOW READINGS. AT SOME POINT, THE REPORTER TESTED THE PATIENT¿S BG METER READING WHICH WAS OVER 600 MG/DL. THE PATIENT WAS ALSO WEARING AN OMNIPOD INSULIN PUMP. THE PATIENT AND HIS WIFE DECIDED TO GO TO THE HOSPITAL, HOWEVER, WHEN THE PATIENT TRIED TO GET UP, HE COLLAPSED. THE REPORTER ATTEMPTED CPR ON THE PATIENT BUT THE PATIENT ULTIMATELY PASSED AWAY. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500271 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Other| D INSULIN PUMP.