BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7

    MDR report key: 24416441 · Received February 23, 2026

    Report

    Report Number
    MW5184233
    Event Type
    Injury
    Date Received
    February 23, 2026
    Date of Event
    February 12, 2026
    Report Date
    February 17, 2026
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TYPE 1 DIABETIC ON INSULIN PUMP USING DEXCOM G7 CGM. I WAS SHOPPING WHEN SUDDENLY I FELT MY LIPS GETTING TINGLY, NUMB, SWEATING, FEELING LIKE AN EXTREME LOW BUT MY DEXCOM CGM NEVER ALERTED OR ALARMED. WHEN I CHECKED MY CGM IT SHOWED MY BS WAS 80 WHICH IS IN THE NORMAL RANGE, EXPLAINING WHY IT DIDN'T ALARM. I FAINTED AND INTERVENTION WAS PROVIDED. WHEN I CAME TO AND MY ACTUAL BLOOD DRAWN, I WAS BELOW 40 INDICATING WHEN I PASSED OUT MY BS WAS EVEN LOWER. I AM LUCKY THIS WAS NOT FATAL AND THAT I LISTENED TO MY BODY AND NOT THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473637 G7 INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention| L ATORVASTATIN.| INSULIN.| MEDTRONIC 780G INSULIN PUMP.| MULTI VITAMIN.| VITAMIN D.