BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4753451 · Received May 6, 2015

    Report

    Report Number
    3004753838-2015-03545
    Event Type
    Malfunction
    Date Received
    May 6, 2015
    Date of Event
    March 8, 2015
    Report Date
    April 8, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT RECEIVER WAS NOT RETURNED TO DEXCOM. THE TRANSMITTER (PART NUMBER STT-GL-003/SERIAL NUMBER (B)(4)/LOT NUMBER 5192109), BEING USED WITH THE COMPLAINT RECEIVER WAS RETURNED ON (B)(4) 2015. THE RETURNED TRANSMITTER 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. EVALUATION OF THE TRANSMITTER DID NOT CONFIRM THE REPORTED EVENT OF A PERMANENT OUT OF RANGE SIGNAL.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT PERMANENT OUT OF RANGE SIGNAL ON (B)(6) 2015. THE PATIENT DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296065 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649-PNK 5191806

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR