BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6

    MDR report key: 10091573 · Received May 26, 2020

    Report

    Report Number
    MW5094673
    Event Type
    Injury
    Date Received
    May 26, 2020
    Date of Event
    May 8, 2020
    Report Date
    May 21, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I UPGRADED FROM DEXCOM G5 GLUCOSE SENSORS TO THE G6 SENSOR ABOUT THREE WEEKS AGO. SINCE I STARTED USING IT, I'VE HAD A WORSENING RASH LIMITED TO THE AREA WHERE THE ADHESIVE IS. I HAVE NO KNOWN ALLERGIES, DON'T USE ANY LOTION, AND FOUND THAT QUITE A FEW OTHERS ONLINE HAVE THIS SAME ISSUE AS WELL AS BRUISING FROM THE STRONG SPRING-LOAD OF THE APPLICATOR. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553978 DEXCOM G6 INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR