BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 20386173 · Received October 7, 2024

    Report

    Report Number
    3004753838-2024-258385
    Event Type
    Injury
    Date Received
    October 7, 2024
    Date of Event
    September 19, 2024
    Report Date
    October 7, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A WIRE/NEEDLE/CANNULA DAMAGED OR MISSING OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN, WHICH IS OFF-LABEL USAGE OF THE DEVICE ON (B)(6) 2024. ON THE SAME DAY, THE PATIENT REMOVED THE SENSOR BECAUSE IT FAILED ( REPORTED IN 240919-015870) BUT WHEN SHE REMOVED THE SENSOR, THE ENTIRE SENSOR WIRE GOT STUCK IN HER SKIN. THERE WAS A PORTION OF THE SENSOR THAT WAS STICKING OUT OF HER SKIN BUT WHEN SHE TRIED TO REMOVE IT HERSELF USING TWEEZERS, IT MOVED THE WIRE AND THE ENTIRE WIRE WAS STUCK INSIDE HER SKIN. ON (B)(6) 2024, THE PATIENT WENT TO THE HOSPITAL. THERE THEY ANAESTHETIZED HER ABDOMEN MADE AN "X" CUT TO REMOVE THE WIRE. THE WIRE WAS SUCCESSFULLY REMOVED AND THEY PRESCRIBED MUPIROCIN OINTMENT TO AVOID INFECTION. AT THE TIME OF THE REPORT THE PATIENT WAS OKAY. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2546470 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1824175001

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other