BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22372280 · Received July 1, 2025

    Report

    Report Number
    3004753838-2025-168470
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    May 22, 2025
    Report Date
    July 1, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270004109
    PMA / PMN Number
    K213919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CMPL-(B)(4). 250616-015716 012 MW5170730, 250616-015372 012 MW5170731, 250616-009171 213 MW5170732, 250616-015055 213 MW5170733, 250616-016104 213 MW5170734.

    Description of Event or Problem · 0

    A VOLUNTARY MEDWATCH REPORT WAS RECEIVED ON (B)(6) 2025. IT WAS REPORTED THAT A DETACHED OR MISSING SENSOR WIRE OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1418660 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI 00386270004109

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male