BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 16616549 · Received March 25, 2023

    Report

    Report Number
    3004753838-2023-064922
    Event Type
    Malfunction
    Date Received
    March 25, 2023
    Date of Event
    February 23, 2023
    Report Date
    March 24, 2023
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    CRITICAL ALERT DOESN¿T CLEAR EVEN IF THE IN-APP CRITICAL ALERT HAS BEEN ALLOWED IN SETTINGS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379060 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male