BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4951171 · Received July 29, 2015

    Report

    Report Number
    3004753838-2015-80004
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Date of Event
    June 30, 2015
    Report Date
    July 1, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED. EVALUATION IS NOT COMPLETE. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF DEVICE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED FAULT COULD NOT BE REPRODUCED. A REVIEW OF THE DOWNLOADED RECEIVER LOG FOUND ERRORS THAT WERE NOT RELATED TO THE CUSTOMER COMPLAINT. THE RECEIVER CASE WAS OPENED FOR FURTHER EVALUATION. TROUBLE SHOOTING DURING AN INTERIOR INSPECTION CONFIRMED THE REPORTED EVENT OF A THE RECEIVER REBOOTING WITHOUT MANUAL RESTART. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE BATTERY.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015, TO REPORT THAT ON (B)(6) 2015, THEIR RECEIVER REBOOTED WITHOUT MANUAL RESTART. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492728 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649-BLU 5195789

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR