BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 15883098 · Received November 29, 2022

    Report

    Report Number
    3004753838-2022-222322
    Event Type
    Injury
    Date Received
    November 29, 2022
    Date of Event
    October 3, 2022
    Report Date
    November 29, 2022
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    40386270000253
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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

    IT WAS REPORTED THAT A SKIN REACTION OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT DEVELOPED REDNESS AND PIMPLES UNDER THE SENSOR PATCH. THE PATIENT HAD ITCHING SENSATION AND PAIN IN THE AREA. PRIOR TO SENSOR INSERTION THE AREA WAS PREPPED WITH ALCOHOL. ON (B)(6) 2022, THE PATIENT CONSULTED A HEALTHCARE PERSONNEL (HCP) AND WAS PRESCRIBED ORAL HYDROCODONE (UNSPECIFIED DOSAGE) TO HELP RELIEVE THE PAIN FROM THE SKIN REACTION. AT THE TIME OF THE CALL, THE PATIENT STATED THE REACTION AREA IS HEALING AND SHE¿S DOING FINE. A PHOTOGRAPH WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS CONFIRMED VIA PHOTOGRAPHIC INSPECTION. 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
    2574272 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI 40386270000253

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Other