BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 19611530 · Received June 25, 2024

    Report

    Report Number
    3004753838-2024-150858
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    May 5, 2024
    Report Date
    June 25, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270002808
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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). H6 CODES: HEALTH EFFECT - CLINICAL CODE - E2010 NEEDLE STICK/PUNCTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SKIN REACTION OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM, WHICH IS OFF LABEL USAGE OF THE DEVICE. ON 05/05/2024, THE PATIENT EXPERIENCED A SKIN REACTION WITH INFECTION ON THE NEEDLE PUNCTURE. THE PATIENT CONSULTED HER DOCTOR BECAUSE HER ARM WAS SWOLLEN, AND SHE WAS DIAGNOSED WITH SKIN INFECTION. NO LABORATORY TESTS WERE PERFORMED. THE DOCTOR PRESCRIBED ORAL ANTIBIOTIC (AMOXICILLIN 875-135 MG 1 TABLET EVERY 12 HOURS). THE AREA WAS PREPARED WITH SOAP AND WATER BEFORE PLACING THE SENSOR ON THE BODY. AT THE TIME OF THE REPORT THE PATIENT WAS RECOVERED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640586 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1724025001 00386270002808

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Other