BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 19994012 · Received August 15, 2024

    Report

    Report Number
    3004753838-2024-204743
    Event Type
    Injury
    Date Received
    August 15, 2024
    Date of Event
    July 3, 2024
    Report Date
    August 15, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270004109
    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).

    Description of Event or Problem · 0

    DEXCOM WAS MADE AWARE ON 07/19/2024, THAT ON 07/03/2024, THE PATIENT EXPERIENCED A SKIN REACTION. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2024. IT WAS REPORTED THE PATIENT EXPERIENCED A SKIN INFECTION AT THE SENSOR SITE. UPON SENSOR REMOVAL, THE SENSOR WIRE WAS MISSING FROM THE SENSOR POD. THE EVENT OCCURRED 4 DAYS AFTER THE SENSOR INSERTION INTO THE ARM. ON 07/03/2024, THE PATIENT'S SENSOR FAILED (CAPTURED IN SR 240722-011349) AND WHEN THE SENSOR WAS REMOVED, THE SENSOR WIRE WAS MISSING. ON 07/06/2024, THE SENSOR SITE WAS RED AND THE PATIENT CALLED THE EMERGENCY ROOM (ER) AND WAS ADVISED TO PLACE A WARM CLOTH ON THE AREA FOR 24 HOURS. ON 07/08/2024, THE PATIENT WENT TO THE DOCTOR AND THE PATIENT UNDERWENT AN X-RAY. NO RETAINED SENSOR WIRE WAS NOTED ON THE X-RAY. THE PATIENT WAS DIAGNOSED WITH A SKIN INFECTION AND WAS PRESCRIBED ORAL BACTRIM FOR 4 DAYS AND ALSO APPLIED HEAT TO THE AREA. AT THE TIME OF REPORT, THE PATIENT STATED THE SWELLING HAS SUBSIDED, BUT THERE IS A STILL A ¿LUMP¿ PRESENT. THE PATIENT ALSO HAS PAIN IN THE AREA THAT HAS PERSISTED. THE ALLEGATION AND 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
    1176918 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1724087001 00386270004109

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other