BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 10751841 · Received October 28, 2020

    Report

    Report Number
    3004753838-2020-126905
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    September 30, 2020
    Report Date
    October 28, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000385
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COM-2012074-20. 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 A "SESSION ENDED, I HAVE A NEW TRANSMITTER" MESSAGE OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED AS A "SESSION ENDED" MESSAGE WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINE TO BE A TRANSMITTER FAILED ERROR. THE REPORTED EVENT OF A "SESSION ENDED, I HAVE A NEW TRANSMITTER" MESSAGE IS REPORTABLE BASED ON THE FINDING OF A TRANSMITTER FAILED ERROR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214697 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-02 5275347 00386270000385

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR