BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 SENSORS

    MDR report key: 23595199 · Received November 19, 2025

    Report

    Report Number
    MW5179026
    Event Type
    Injury
    Date Received
    November 19, 2025
    Date of Event
    September 1, 2025
    Report Date
    November 18, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CALLER STATED THAT SHE HAS TWO FAILED DEXCOM SENSORS THAT ALSO READS INACCURATELY. SHE SAID SHE HAS A LOT OF SENSORS IN HAND BUT ALL MADE IN MALAYSIA WHICH ARE THE ONES THAT ARE FAILING AND GIVING INCORRECT READING. SHE CALLED DEXCOM AND SUGGESTED THAT SHE RETURN TO MALAYSIA FAILED ONES BUT THEY REFUSED. PT CODE: 4580. DEVICE CODE: 3023; 1535. REF REPORT: MW5179025.

    Description of Event or Problem · 0

    ADD'L INFO RECEIVED ON 11/21/2025 FOR REPORT MW5179026 TO UPDATE PROCODE TO QBJ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313764 G7 SENSORS INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention