BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 21259712 · Received January 28, 2025

    Report

    Report Number
    3004753838-2025-024344
    Event Type
    Injury
    Date Received
    January 28, 2025
    Date of Event
    May 22, 2024
    Report Date
    January 28, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SENSOR FAILURE OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN. THE DATE OF EVENT IS AN APPROXIMATION. ON (B)(6) 2024, THE PATIENT EXPERIENCED UNCONSCIOUSNESS. AN HOUR AFTER EXPERIENCING UNCONSCIOUSNESS, THE GIRLFRIEND FOUND HIM AND THE G6 APP SHOWED SENSOR FAILED ERROR. THE GIRLFRIEND REPORTEDLY DID NOT RECEIVE AN ALERT THAT HE WAS HYPOGLYCEMIC. THE GIRLFRIEND CALLED 911. EMERGENCY MEDICAL SERVICE (EMS) GAVE THE PATIENT GLUCOSE AND IV FLUIDS. HE REGAINED CONSCIOUSNESS AND THE BLOOD GLUCOSE WAS CHECKED BUT NOT REMEMBERED. THE PATIENT REQUESTED EVALUATION IN THE EMERGENCY DEPARTMENT (ED). HE UNDERWENT BLOOD WORK AND LABORATORY TESTS AND WAS DISCHARGED THE SAME DAY. AT THE TIME OF THE REPORT, THE PATIENT WAS STABLE AND OKAY. PERFORMANCE DATA WAS REVIEWED. THE ALLEGATION WAS CONFIRMED VIA DATA AS A SENSOR FAILURE AFTER WARM-UP. DATA WAS RECEIVED BUT DOES NOT REFLECT FULL INVESTIGATION WINDOW. 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
    1500947 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other OMNIPOD