BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM CGM G6

    MDR report key: 22914324 · Received August 28, 2025

    Report

    Report Number
    MW5175350
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    August 20, 2025
    Report Date
    August 22, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DEXCOM SENSOR FAILED APP DID NOT GIVE CRITICAL ALERT MY BS (BLOOD SUGAR) WAS GOING UP OVER 600. WHEN I STARTED FEELING ILL, I REALIZED MY DEXCOM HAD FAILED. I USED MY GLUCOMETER TO TEST AND FOUND OUT IT WAS HI. I TRIED TO RESTART 2 DEXCOM SENSORS BUT THEY FAILED START UP. IT WAS SAYING THE SENSOR HAD ALREADY BEEN USED BUT IT WAS A NEW BOX AND NEW SENSORS FROM THE BOX. UNOPENED PACKAGES. I COULD NOT CONTACT A SERVICE REP AT THE COMPANY & NEVER RECEIVED A FOLLOW UP AFTER I SUBMITTED ONLINE FORMS & REQUESTING CALL BACK. MY BS WAS ELEVATED FOR AN EXTENDED PERIOD OF TIME WHICH PUT MY LIFE IN DANGER. PATIENT CODE: 1905. DEVICE CODE: 1014, 2588. REFERENCE REPORT# MW5175349.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2130307 DEXCOM CGM G6 INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Other