BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 15831660 · Received November 20, 2022

    Report

    Report Number
    3004753838-2022-217537
    Event Type
    Injury
    Date Received
    November 20, 2022
    Date of Event
    October 24, 2022
    Report Date
    November 20, 2022
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    40386270000253
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    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 ARM, WHICH IF OFF LABEL USAGE OF THE DEVICE ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT WOKE EARLY IN THE MORNING WHEN HIS CGM ALERTED FOR A VALUE OF 40 MG/DL. THE PATIENT WAS WEAK, BUT WAS ABLE GET UP, INGESTED SOME CARBS AND CALLED HIS HEALTHCARE PERSONNEL (HCP) FOR ASSISTANCE. HE WAS INSTRUCTED TO INGEST CARBS AND GO TO THE EMERGENCY DEPARTMENT (ED). HE DROVE HIMSELF TO THE ED WHERE HE WAS TREATED WITH IV FLUIDS, OXYGEN, AND BLOOD TESTS WERE PERFORMED. WHILE IN THE ED, HIS CGM DISPLAYED 137 MG/DL BUT HIS BG WAS 203 MG/DL. HE WAS RELEASED FROM THE ED APPROXIMATELY EIGHT HOURS LATER. AT THE TIME OF THE REPORT, THE PATIENT WAS DOING OKAY. 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
    2526070 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-24 NI 40386270000253

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other