BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM, INC.

    MDR report key: 23144411 · Received September 25, 2025

    Report

    Report Number
    MW5176564
    Event Type
    Injury
    Date Received
    September 25, 2025
    Date of Event
    September 18, 2025
    Report Date
    September 21, 2025
    Manufacturer
    G7
    Product Code
    QBJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ON THURSDAY MORNING, MY INSULIN PUMP DELIVERED EXTRA INSULIN BASED ON THE BLOOD GLUCOSE READING IT RECEIVED FROM MY DEXCOM G7 SENSOR. UNFORTUNATELY, THE READING PROVIDED BY THE G7 WAS NOT ACCURATE. BECAUSE OF THIS INCORRECT INFORMATION, I RECEIVED MORE INSULIN THAN I ACTUALLY NEEDED, WHICH CAUSED MY BLOOD SUGAR TO DROP SEVERELY. AS A RESULT, I PASSED OUT, FELL, AND HIT MY HEAD. EMERGENCY MEDICAL CARE WAS REQUIRED, AND I ENDED UP IN THE EMERGENCY ROOM FOR EVALUATION AND TREATMENT. THIS IS NOT THE FIRST TIME I'VE EXPERIENCED PROBLEMS WITH THE DEXCOM G7. SINCE STARTING WITH IT, THE READINGS HAVE CONSISTENTLY BEEN UNRELIABLE, FORCING ME TO PRICK MY FINGER COUNTLESS TIMES TO CONFIRM MY ACTUAL BLOOD SUGAR LEVELS. DESPITE THE EXPECTATION THAT THE G7 WOULD REDUCE THE NEED FOR FINGERSTICKS, IT HAS BEEN INACCURATE ENOUGH THAT I CANNOT TRUST IT ON ITS OWN. THE INACCURATE READING ON THURSDAY WAS ESPECIALLY DANGEROUS AND DIRECTLY LED TO A MEDICAL EMERGENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301095 DEXCOM, INC. INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ G7 1725162002

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Life Threatening| H| R NOVOLOG.