BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7229325 · Received January 30, 2018

    Report

    Report Number
    3004753838-2018-000684
    Event Type
    Malfunction
    Date Received
    January 30, 2018
    Date of Event
    January 6, 2018
    Report Date
    January 6, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    10386270000221
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PT REPORTS " WISH THERE WERE FEWER 'NO SIGNAL' EVENTS TO MY(B)(4) (EVEN WHEN IT'S NEXT TO THE DEVICE). "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71412 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9438-06 10386270000221

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR