BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3714480 · Received March 31, 2014

    Report

    Report Number
    3004753838-2014-19156
    Event Type
    Malfunction
    Date Received
    March 31, 2014
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    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). DEVICE EVALUATION: 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 SPECIFICATION. ADDITIONALLY, THE TRANSMITTER 9438-01/60DX8, WAS RETURNED. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND FOUND NO DEFECTS. FUNCTIONAL TESTING WAS PERFORMED AND THE TRANSMITTER FAILED. THE COMPLAINT OF PERMANENT LOSS OF "Y" WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE TRANSMITTER.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED DEVICE DID NOT CONFIRM THE PERMANENT OUT OF RANGE SIGNAL.

    Description of Event or Problem · 1

    CONSUMER REPORTED PERMANENT OUT OF RANGE SIGNAL. THE CONSUMER DID NOT REPORT ANY MEDICAL INTERVENTION OR INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192573 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS, PRODUCT CODE:MDS MDS DEXCOM INC. MT20649

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR