BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM PQF

    MDR report key: 7378097 · Received March 28, 2018

    Report

    Report Number
    3004753838-2018-31232
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    February 26, 2018
    Report Date
    February 28, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, THE PATIENT EXPERIENCED A LOSS OF CONNECTION. IT WAS REPORTED THAT THE PATIENT WAS USING AN UNSUPPORTED OPERATING SYSTEM. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. LABELING INDICATES: THE DEXCOM G5 MOBILE APPLICATION IS ONLY COMPATIBLE FOR SELECT SMART DEVICES AND MOBILE OPERATING SYSTEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221765 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM PQF CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9438-06 6006242

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR