BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7509396 · Received May 11, 2018

    Report

    Report Number
    3004753838-2018-051132
    Event Type
    Malfunction
    Date Received
    May 11, 2018
    Date of Event
    April 8, 2018
    Report Date
    April 12, 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

    DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. VOLTAGE TESTING WAS PERFORMED AND RESULTED IN 0 VOLTAGE. A REVIEW OF THE DOWNLOADED DATA LOG CONFIRMED THE REPORTED EVENT OF LOSS OF CONNECTION. THE PROBABLE CAUSE OF THE ISSUE IS NO COMMUNICATION DUE TO A GAB IN THE DEVICE LOGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349803 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9438-06 6007097 10386270000221

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR