BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4141136 · Received October 3, 2014

    Report

    Report Number
    3004753838-2014-28929
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 7, 2014
    Report Date
    September 7, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT TRANSMITTER DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DAMAGE WAS FOUND. FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS RECEIVED IN A CONDITION MAKING EVALUATION NOT POSSIBLE. REPORTED FAULT COULD NOT BE REPRODUCED DURING INVESTIGATION OF THE TRANSMITTER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT AN OUT OF RANGE SIGNAL ON (B)(6) 2014. AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT, NO MEDICAL INTERVENTION OR INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618493 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-01

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR