BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 13846188 · Received March 22, 2022

    Report

    Report Number
    3004753838-2022-043060
    Event Type
    Injury
    Date Received
    March 22, 2022
    Date of Event
    February 23, 2022
    Report Date
    March 21, 2022
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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, THE PATIENT LOST CONSCIOUSNESS, FELL, AND HIT HIS HEAD RESULTING IN A CUT TO THE AREA. HE WAS GIVEN HONEY AND WAS TRANSPORTED TO THE EMERGENCY DEPARTMENT (ED) WHERE THE BG FINGER STICK WAS 21 MG/DL AND THE CGM VALUE WAS 51 MG/DL. AFTER REGAINING CONSCIOUSNESS HE CONTINUED TO EAT HONEY TO RAISE THE BLOOD GLUCOSE, AND LATER STATED HE WAS NOT TREATED WITH MEDICATION AT THE ED. HE WAS MONITORED AT THE HOSPITAL LESS THAN 24 HOURS OVERNIGHT AND WAS DISCHARGED THE NEXT DAY IN STABLE CONDITION. 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
    587707 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-24 5294683

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Other