BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7496870 · Received May 8, 2018

    Report

    Report Number
    3004753838-2018-049416
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    March 12, 2018
    Report Date
    April 9, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    00386270000002
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT EXPERIENCED ADVERSE EVENTS ON DIFFERENT DAYS WITH THE SAME DEVICE. THE FOLLOWING REPORTS ARE BEING SUBMITTED: 180410-000190,180410-000200,180410-000205,180410-000216,180410-000224,180410-000231,180410-000241,180410-000251,180410-000257,180410-000261,180410-000271,180410-000277,180410-000283,180410-000289,180410-000297,180410-000303,180410-000311,180410-000317,180410-000327,180410-000336,180410-000345,180410-000347,180410-000356,180410-000359,180410-000363,180410-000369,180410-000378,180410-000384,180410-000394,180410-000397.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 04/09/2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. IT WAS DETERMINED THAT LOSS OF CONNECTION WAS RELATED TO THE MOBILE APPLICATION. DATA WAS RETURNED AND EVALUATED. THE REPORTED EVENT OF A LOSS OF CONNECTION WAS NOT CONFIRMED VIA DATA. A ROOT CAUSE COULD NOT BE DETERMINED. IT WAS REPORTED THAT THE OPERATING SYSTEM FOR THE SMART DEVICE WAS NOT A SUPPORTED SYSTEM. LABELING INDICATES THAT THE DEXCOM CGM APPLICATION IS ONLY COMPATIBLE FOR SELECT DEVICES AND OPERATING SYSTEMS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339850 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. N/A 00386270000002

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR