BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5227069 · Received November 16, 2015

    Report

    Report Number
    3004753838-2015-63169
    Event Type
    Malfunction
    Date Received
    November 16, 2015
    Date of Event
    October 23, 2015
    Report Date
    October 23, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000125
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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) 2015 TO REPORT THAT ON (B)(6) 2015, PATIENT EXPERIENCED AN INTERMITTENT OUT OF RANGE SIGNAL. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE COMPLAINT DEVICE WASN'T RETURNED, BUT THE RECEIVER ( B)(4)) THAT WAS USED WITH THE DEVICE HAS BEEN RECEIVED FOR EVALUATION ON (B)(6) 2015. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE RETURNED RECEIVER (PART NUMBER STK-DR-BLU/SERIAL NUMBER (B)(4)/LOT NUMBER 5202305), 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; HOWEVER, A REVIEW OF THE DIAGNOSTIC CHART CONFIRMED THE REPORTED EVENT OF AN INTERMITTENT OUT OF RANGE SIGNAL. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755313 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-05 5201935 00386270000125

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR