BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 24916442 · Received April 17, 2026

    Report

    Report Number
    3004753838-2026-133817
    Event Type
    Injury
    Date Received
    April 17, 2026
    Date of Event
    April 3, 2026
    Report Date
    April 17, 2026
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270004109
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.

    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 FREQUENTLY BETWEEN 04/02/2026 AND 04/03/3036. THE WEARABLE WAS INSERTED INTO AN OFF-LABEL INSERTION SITE. ON (B)(6), IN THE EARLY MORNING HOURS APPROXIMATELY 7:30 AM, THE PATIENT EXPERIENCED LOW CGM. THE PATIENT EXPERIENCED SHAKINESS, CONFUSION, AND NEARLY LOSING CONSCIOUSNESS. TREATMENT WAS INITIATED AT HOME BY THE WIFE WITH TWO INJECTIONS OF GLUCAGON APPROXIMATELY 10¿15 MINUTES APART DUE TO LACK OF IMPROVEMENT AFTER THE FIRST DOSE. ONCE THE PATIENT WAS ALERT ENOUGH TO SWALLOW, HE WAS GIVEN THREE TUBES OF LIQUID GLUCOSE, FOLLOWED BY BREAD WITH JAM. DESPITE TREATMENT, CGM READINGS CONTINUED TO READ LOW RANGE. EMS WERE CALLED BY THE WIFE. UPON ARRIVAL, EMS PERFORMED BG WHICH READ 97 MG/DL AND 89 MG/DL WHILE CGM CONTINUED TO READ JUST "LOW". EMS REMAINED ON SCENE FOR APPROXIMATELY 30¿60 MINUTES ONLY, THEY TRIED CALIBRATING THE SENSOR TWICE WITHOUT IMPROVEMENT. AT THAT TIME AFTER SYMPTOMS PARTIALLY IMPROVED AND THE PATIENT STARTED A NEW SENSOR. 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. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976211 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1725191002 00386270004109

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Life Threatening| O GLUCAGON INJECTION| LIQUID GLUCOSE| TANDEM T:SLIM X2