BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22819626 · Received August 15, 2025

    Report

    Report Number
    3004753838-2025-224913
    Event Type
    Injury
    Date Received
    August 15, 2025
    Date of Event
    August 3, 2025
    Report Date
    August 15, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270002860
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. H6 HEALTH EFFECT - CLINICAL CODE - E014302 DECREASED LEVEL OF CONSCIOUSNESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. ON (B)(6) 2025, AROUND 9:00AM, THE PATIENT WAS WOKEN UP BY HIS BROTHER AND AT THIS TIME, THE PATIENT STATED THEY WERE HYPOGLYCEMIC (NO SYMPTOMS REPORTED) AND THE CGM HAD LOW READINGS BUT HE DID NOT HEAR ANY NOTIFICATIONS. HE STATED FOR SOME REASON, THE NOTIFICATIONS ON THE RECEIVER WAS TURNED OFF. HE STATED HE WOKE UP WITH EMERGENCY MEDICAL SERVICES THERE (IT IS UNKNOWN AT WHAT POINT THE PATIENT LOST CONSCIOUSNESS) AND HE WAS BEING TREATED WITH GLUCOSE. IT WAS REPORTED THAT THE NIGHT PRIOR, THE PATIENT TOOK 10 UNITS OF LONG-ACTING INSULIN. AT THE TIME OF THE REPORT, THE PATIENT WAS DOING OKAY. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. PROBLEM COULD NOT BE CONFIRMED AND PROBABLE CAUSE CANNOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301366 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 18008037 00386270002860

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other INSULIN PEN