BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5185302 · Received October 28, 2015

    Report

    Report Number
    3004753838-2015-62653
    Event Type
    Malfunction
    Date Received
    October 28, 2015
    Date of Event
    October 8, 2015
    Report Date
    October 8, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000125
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT'S MOTHER 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.

    Description of Event or Problem · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE 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. ADDITIONALLY, THE RECEIVER (PART NUMBER STK-PR-PNK/SERIAL NUMBER (B)(4)/LOT NUMBER 5201273), BEING USED WITH THE TRANSMITTER WAS RETURNED FOR EVALUATION. THE DEVICE 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. A REVIEW OF THE DIAGNOSTIC CHART CONFIRMED THE REPORTED EVENT OF A INTERMITTENT OUT OF RANGE SIGNAL. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716227 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-05 5202367 00386270000125

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR