BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUOUS GLUCOSE MONITOR

    MDR report key: 22236400 · Received June 17, 2025

    Report

    Report Number
    MW5171601
    Event Type
    Injury
    Date Received
    June 17, 2025
    Date of Event
    June 8, 2025
    Report Date
    June 8, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I TOOK A WALK WITH MY DOG AND HAD MY DEXCOM G7 SENSOR ON AND MY TANDEM MOBI PUMP IN ACTIVE MODE WITH THE USE OF CONTROL IQ. I STARTED TO FEEL THE SYMPTOMS OF A LOW AND MY DEXCOM WAS READING 96 WITH AN ARROW INDICATING A SLOW DECLINE. I FINISHED OUT MY WALK AND ARRIVED HOME BUT STILL FELT WEIRD. I TESTED MY BLOOD SUGAR WITH MY METER AND WAS 50. THAT IS A VERY BIG DIFFERENCE AND COULD HAVE RESULTED IN ME PASSING OUT ON MY WALK. I COULD HAVE HIT MY HEAD OR HAD A SEIZURE. THIS IS PROBABLY THE FOURTH TIME THIS HAS HAPPENED SINCE I WAS FORCED TO SWITCH FROM THE G6 TO THE G7 AND I'VE ONLY BEEN USING IT FOR ABOUT TWO WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28527 CONTINUOUS GLUCOSE MONITOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM, INC. 1825093007

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Life Threatening DEXCOM G7 CGM.| DICLOFENAC 30 MG.| HUMALOG INSULIN THROUGH TANDEM MOBI PUMP.| IRON.| MAGNESIUM.| TRI-LO MARZIA BIRTH CONTROL.| VENLAFAXINE 37.5 MG.