BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 9988858 · Received April 22, 2020

    Report

    Report Number
    3004753838-2020-037976
    Event Type
    Malfunction
    Date Received
    April 22, 2020
    Date of Event
    April 21, 2020
    Report Date
    April 22, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS DETERMINED THAT THE SIGNAL LOSS WAS RELATED TO THE MOBILE APPLICATION. IT WAS INDICATED THAT THE OPERATING SYSTEM FOR THE SMART DEVICE WAS NOT A SUPPORTED SYSTEM, WHICH IS OFF-LABEL USAGE OF THE DEVICE. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND SIGNAL LOSS WAS FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS THE TRANSMITTER AND APP WERE UNABLE TO ESTABLISH A CONNECTION. NO O INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449190 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR