BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 20624656 · Received November 6, 2024

    Report

    Report Number
    3004753838-2024-290152
    Event Type
    Injury
    Date Received
    November 6, 2024
    Date of Event
    October 1, 2024
    Report Date
    November 6, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 A SIGNAL LOSS OCCURRED. ON (B)(6)2024, THE PATIENT REPORTED THAT ON (B)(6)2024, THEY EXPERIENCED A SIGNAL LOSS WHICH OCCURRED AN UNSPECIFIED DAY AFTER THE SENSOR HAD BEEN INSERTED IN THE ARM. ON APPROXIMATELY (B)(6)20224 THE PATIENT WAS WATCHING TELEVISION IN HIS ROOM AND HE DID NOT HAVE ANY SYMPTOMS BUT NOTICED A FREQUENT SIGNAL LOSS ON THE PHONE. HE SUDDENLY LOST CONSCIOUSNESS AND HIS NEIGHBOUR WENT TO CHECK ON HIM AND FOUND HIM UNCONSCIOUS. THE NEIGHBOUR CALLED 911. THE PATIENT WAS TREATED WITH GLUCAGON. IN THE AMBULANCE HE REGAINED CONSCIOUSNESS AND WAS TAKEN TO THE EMERGENCY DEPARTMENT (ED). THE PATIENT DIDN'T KNOW IF THERE WAS ANY BLOOD GLUCOSE (BG) TAKEN NOR THE VALUES. THE PATIENT WAS MONITORED FOR 2 HOURS AT THE ED. SOME TIME DURING THE MONITORING THE BG READING WAS 89 MG/DL. THEY PROVIDED THE PATIENT WITH FOOD. BEFORE HE WAS DISCHARGED THE CGM READING WAS 394 MG/DL AND THERE WAS NO BG TAKEN. THE PATIENT WAS DISCHARGED THE SAME DAY. AT THE TIME OF THE REPORT THE PATIENT WAS FINE. NO OTHER DETAILS WERE DOCUMENTED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1460394 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other