BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5002389 · Received August 13, 2015

    Report

    Report Number
    3004753838-2015-75093
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    May 9, 2015
    Report Date
    May 9, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND FOUND NO OBSERVATIONS RELATED TO THE CUSTOMER COMPLAINT. FUNCTIONAL TESTING WAS PERFORMED AND FOUND NO FAILURES RELATED TO THE COMPLAINT. THE DATA LOG WAS DOWNLOADED AND REVIEWED FINDING A HARDWARE ERROR. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE UI-U1 FAILURES AND HARDWARE ERRORS.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015, TO REPORT THAT ON (B)(6) 2015, THEIR RECEIVER WOULD NOT TURN ON. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534418 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649-BLU 5150450

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR