BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 15720312 · Received November 3, 2022

    Report

    Report Number
    3004753838-2022-204909
    Event Type
    Injury
    Date Received
    November 3, 2022
    Date of Event
    October 4, 2022
    Report Date
    November 2, 2022
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2022. ON (B)(6) 2022 AT 5:30 AM, THE PATIENT REPORTED HER DAUGHTER COULD NOT UNDERSTAND WHAT SHE WAS DOING [PRESUMED TO MEAN ERRATIC BEHAVIOR] AND CALLED EMERGENCY MEDICAL SERVICES (EMS). AN UNSPECIFIED TIME AFTERWARD, THE PATIENT LOST CONSCIOUSNESS. UPON ARRIVAL, EMS PERFORMED A BG WHICH WAS 30 MG/DL BUT THE PATIENT¿S CGM DISPLAYED 298 MG/DL. EMS TREATED THE PATIENT WITH GLUCOSE AND THE PATIENT REGAINED CONSCIOUSNESS. ONCE ALERT, EMS INSTRUCTED THE PATIENT TO INGEST A PEANUT BUTTER SANDWICH AND ORANGE JUICE. IT WAS NOT CONFIRMED IF THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. AT THE TIME OF THE REPORT, THE PATIENT WAS RECOVERING AT HOME WITH HER DAUGHTER. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE E 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
    2787884 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Other ACETAMINOPHEN