BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 16746591 · Received April 14, 2023

    Report

    Report Number
    3004753838-2023-078016
    Event Type
    Malfunction
    Date Received
    April 14, 2023
    Date of Event
    November 29, 2022
    Report Date
    April 14, 2023
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNKNOWN CRITICAL ALERT OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED EVENT OF AN UNKNOWN CRITICAL ALERT IS REPORTABLE BASED ON THE FINDING OF APP CRASH. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818161 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female