BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM

    MDR report key: 5384188 · Received January 21, 2016

    Report

    Report Number
    3004753838-2016-40521
    Event Type
    Malfunction
    Date Received
    January 21, 2016
    Date of Event
    January 1, 2016
    Report Date
    January 1, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000156
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM ON (B)(6) 2016 TO REPORT THAT ON (B)(6) 2016, PATIENT EXPERIENCED A PERMANENT OUT OF RANGE SIGNAL. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    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 5201166), BEING USED WITH THE COMPLAINT RECEIVER, WAS RETURNED ON 03/21/2016. 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. THE REPORTED EVENT OF A PERMANENT OUR OF RANGE SIGNAL WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40786 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM MDS MDS DEXCOM, INC. MT22495 5207990 00386270000156

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR