BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4173750 · Received October 15, 2014

    Report

    Report Number
    3004753838-2014-25687
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 4, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED COMPLAINT DEVICE WAS VISUALLY INSPECTED AND FOUND NO OBSERVATIONS RELATED TO THE COMPLAINT. RECEIVER DATA WAS DOWNLOADED AND FOUND NO HARDWARE ERRORS RELATED TO THE COMPLAINT. DEVICE FAILED FUNCTIONAL TESTING. FURTHER TESTS SHOWED THAT THE SPEAKER IS DEFECTIVE. THE ROOT CAUSE WAS DETERMINED TO BE AN ASSEMBLY ERROR.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6)2014 TO CLAIM NO AUDIO OUTPUT ON (B)(6)2014. AT THE TIME OF THE CALL TO DEXCOM TECHNICAL SUPPORT, NO MEDICAL INTERVENTION OR INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654238 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR