BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 10388039 · Received August 10, 2020

    Report

    Report Number
    3004753838-2020-085670
    Event Type
    Injury
    Date Received
    August 10, 2020
    Date of Event
    May 1, 2020
    Report Date
    August 10, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000255
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. DATE OF ISSUE IS AN APPROXIMATION. THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT THAT MAY OR MAY NOT HAVE BEEN ASSOCIATED WITH INACCURATE CGM VALUES. THE PATIENT INJECTED INSULIN BECAUSE SHE NOTICED HER CGM WAS 229 MG/DL WITH DOUBLE ARROW UP. AN HOUR LATER, THE PATIENT EXPERIENCED A SEIZURE, FELL TO THE FLOOR AND HIT HER HEAD; BECAUSE SHE LIVES ALONE, SHE WAS ABLE TO REMAIN COHERENT ENOUGH TO INGEST A SODA. AFTER INGESTING THE SODA, HER BLOOD GLUCOSE INCREASED AND SHE DID NOT NEED TO CALL EMERGENCY MEDICAL SERVICES (EMS) FOR FURTHER ASSISTANCE. BECAUSE SHE WAS UNABLE TO TAKE HER BG AT THE TIME OF THE EVENT, IT WAS UNKNOWN IF THE CGM WAS INACCURATE OR HER BG DROPPED BECAUSE OF THE INSULIN. AT THE TIME OF REPORT, THE PATIENT WAS DOING FINE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION WAS UNABLE TO BE DETERMINED. A PROBABLE CAUSE WAS NOT DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849703 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-45 NI 00386270000255

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other