BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 15532952 · Received October 3, 2022

    Report

    Report Number
    3004753838-2022-183770
    Event Type
    Injury
    Date Received
    October 3, 2022
    Date of Event
    September 4, 2022
    Report Date
    October 7, 2022
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    (B)(4)

    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 EMERGENCY DEPARTMENT PHYSICIAN ATTENDING TO THE PATIENT REPORTED THAT THE PATIENT WAS SLEEPING WHEN HE EXPERIENCED A HYPOGLYCEMIC EVENT. IT WAS REPORTED, THE PATIENT NEVER WOKE UP FROM THE DAY BEFORE BECAUSE HE WAS SEIZING. EMERGENCY MEDICAL SERVICES (EMS) WAS CALLED, AND THE PATIENT WAS TRANSPORTED TO THE EMERGENCY DEPARTMENT (ED). AT THE TIME OF THE EVENT, THE PATIENT¿S CGM DISPLAYED 65 MG/DL BUT HIS BG WAS 30 MG/DL (EMS GLUCOMETER) LOW (HOME GLUCOMETER). THE PATIENT WAS TREATED IN THE ED AND WAS TO BE DISCHARGED LATER THAT DAY PER THE REPORTER. 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.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION WAS RECEIVED ON 10/03/2022. EMERGENCY MEDICAL SERVICES TREATED THE PATIENT WITH IV GLUCOSE AND TRANSPORTED HIM TO THE EMERGENCY DEPARTMENT. IN THE ED, HE WAS GIVEN FOOD, MONITORED, AND RELEASED LATER THAT DAY. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2928640 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Other