BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 21097814 · Received January 7, 2025

    Report

    Report Number
    3004753838-2025-005466
    Event Type
    Injury
    Date Received
    January 7, 2025
    Date of Event
    October 10, 2024
    Report Date
    January 7, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MHRA REFERENCE NUMBER: (B)(4). USER REPORT 2024/012/011/501/017 LABELING INDICATES: INSERTING THE SENSOR AND WEARING THE ADHESIVE PATCH MIGHT CAUSE INFECTION, BLEEDING, PAIN OR SKIN IRRITATIONS (E.G. REDNESS, SWELLING, BRUISING, ITCHING, SCARRING OR SKIN DISCOLORATION).

    Description of Event or Problem · 0

    IT REPORTED VIA USER REPORT ON 12/13/2024 THAT ON 10/10/2024, THE PATIENT EXPERIENCED A SKIN REACTION WITH ITCHING UNDER THE ENTIRE PATCH AREA, WHICH OCCURRED AN UNSPECIFIED DAY AFTER THE SENSOR HAD BEEN INSERTED (NO INFORMATION ABOUT INSERTION SITE). THE NURSE WHO REPORTED THE ISSUE STATED THAT THE PATIENT HAD BAD SKIN REACTIONS WHICH WERE GETTING WORSE OVER TIME, AND THAT THE PATIENT WAS VERY ITCHY ¿ALL OVER¿. THE PATIENT WAS ADVISED TO TRY A BARRIER CREAM, USE AN UNSPECIFIED ANTIHISTAMINE AND SWAP IT FOR OTHER CONTINUOUS GLUCOSE MONITOR (CGM) DEVICES. THE NURSE WAS CONTACTED MULTIPLE TIMES TO OBTAIN MORE INFORMATION REGARDING THE REACTION BEING EXPERIENCED ¿ALL OVER¿, AND TO CLARIFY THE ANTIHISTAMINE TREATMENT, BUT COULD NOT BE REACHED. NO DATA OR PRODUCT WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870365 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Other