BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM

    MDR report key: 4951063 · Received July 29, 2015

    Report

    Report Number
    3004753838-2015-70070
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Date of Event
    July 2, 2015
    Report Date
    July 2, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. THE RECEIVER LOG WAS REVIEWED AND NO ISSUES RELATED TO THE CUSTOMER COMPLAINT WERE FOUND. FUNCTIONAL TESTING WAS PERFORMED ON THE DEVICE AND DEVICE FAILED AUDIO TEST. THE CUSTOMER COMPLAINT OF NO AUDIO OUTPUT WAS CONFIRMED AND THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE SPEAKER SUB-ASSEMBLY.

    Description of Event or Problem · 1

    PATIENT'S FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT THAT ON (B)(6) 2015, PATIENT EXPERIENCED NO AUDIO OUTPUT. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493101 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM MDS MDS DEXCOM, INC. MT22608-BLU 5201250

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR