BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8622485 · Received May 18, 2019

    Report

    Report Number
    3004753838-2019-043025
    Event Type
    Malfunction
    Date Received
    May 18, 2019
    Date of Event
    April 22, 2019
    Report Date
    April 22, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000804
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NO AUDIO FOR LOW ALERT OCCURRED ON THE APP. IT WAS INDICATED THAT THE OPERATING SYSTEM FOR THE SMART DEVICE WAS NOT A SUPPORTED SYSTEM, WHICH IS MISUSE OF THE DEVICE. DATA WAS EVALUATED AND THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415782 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. N/A 00386270000804

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR