BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 21236446 · Received January 25, 2025

    Report

    Report Number
    3004753838-2025-021930
    Event Type
    Injury
    Date Received
    January 25, 2025
    Date of Event
    January 9, 2025
    Report Date
    January 25, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SKIN REACTION OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6)2025. ON (B)(6)2025, THE PEDIATRIC PATIENT EXPERIENCED A SKIN REACTION WITH ITCHING, BURNING, RASH, REDNESS, INFLAMMATION, PIMPLES, BLISTERS, DRY SKIN, DRAINAGE, AND PUSTULES, EXTENDED BEYOND THE PATCH PERIMETER. THE PATIENT WAS SEEN AT THE HOSPITAL AND WAS DIAGNOSED WITH STAPHYLOCOCCUS. THE REACTION WAS TREATED WITH A PRESCRIPTION OF AN UNSPECIFIED ORAL ANTIBIOTIC, A NASAL CREAM AND BODY WASH CALLED DERMOL 500 LOTION. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. PROBLEM COULD NOT BE CONFIRMED AND PROBABLE CAUSE CANNOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2376984 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Female Other