BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4614845 · Received March 18, 2015

    Report

    Report Number
    3004753838-2015-02092
    Event Type
    Malfunction
    Date Received
    March 18, 2015
    Date of Event
    February 22, 2015
    Report Date
    February 22, 2015
    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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RECEIVER WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE TRANSMITTER (9438-05/69D44) THAT WAS BEING USED WITH THE RECEIVER WAS RETURNED ON (B)(4) 2015. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE TEST FAILED, CONFIRMING THE REPORTED EVENT OF A PERMANENT OUT OF RANGE SIGNAL. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE TRANSMITTER.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT A PERMANENT OUT OF RANGE SIGNAL ON (B)(6) 2015. PATIENT WAS ADVISED TO RESET THE DEVICE. 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
    183033 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR