BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4252277 · Received November 14, 2014

    Report

    Report Number
    3004753838-2014-31843
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SUBSEQUENT TO THE SUPPLEMENTAL MDR, THE COMPLAINT TRANSMITTER DEVICE WAS RETURNED TO ANIMAS FOR EVALUATION. DEVICE EVALUATION WAS COMPLETED BY ANIMAS ON (B)(4) 2015. INVESTIGATION RESULTS WERE RECEIVED BY DEXCOM ON (B)(4) 2015. THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO COSMETIC FLAW. 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 INTERMITTENT OUT OF RANGE SIGNAL COULD NOT BE CONFIRMED.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOREIGN DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 ON PATIENT'S BEHALF TO REPORT INTERMITTENT OUT OF RANGE ON (B)(6) 2014. AT THE TIME OF CONTACT THE FOREIGN DISTRIBUTOR DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738638 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-01

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR