BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4850695 · Received June 17, 2015

    Report

    Report Number
    3004753838-2015-05022
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 25, 2015
    Report Date
    May 25, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 AND THERE WAS NO FAILURE DETECTED. THE DEVICE WAS DETERMINED TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION. THE COMPLAINT OF AN INTERMITTENT OUT OF RANGE SIGNAL COULD NOT BE CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT THAT ON (B)(6) 2015, PATIENT EXPERIENCED AN INTERMITTENT OUT OF RANGE SIGNAL. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393013 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-05 5200676

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR