BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 PROFESSIONAL SYSTEM

    MDR report key: 12009217 · Received June 16, 2021

    Report

    Report Number
    3004753838-2021-107449
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    June 14, 2021
    Report Date
    June 16, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    QII
    PMA / PMN Number
    K191833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. 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
    903826 DEXCOM G6 PROFESSIONAL SYSTEM CONTINUOUS GLUCOSE MONITOR QII DEXCOM, INC. 9445-20 5282574

    Patients

    Seq Age Sex Outcome Treatment
    1