BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5152887 · Received October 15, 2015

    Report

    Report Number
    3004753838-2015-62376
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Date of Event
    September 25, 2015
    Report Date
    September 25, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000125
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015, TO REPORT THAT ON (B)(6) 2015 THE PATIENT HAD UNRECOVERABLE LOSS OF ANTENNA. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT TRANSMITTER WAS NOT RETURNED TO DEXCOM. THE RECEIVER (PART NUMBER STK-GL-BLU/SERIAL NUMBER (B)(4)/LOT NUMBER 5190869), BEING USED WITH THE COMPLAINT TRANSMITTER, WAS RETURNED ON 10/21/2015. THE RETURNED RECEIVER WAS VISUALLY INSPECTED AND THE UNIVERSAL SERIAL BUS (USB) DOOR IS BROKEN. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED FAULT COULD NOT BE REPRODUCED AND THERE WAS NO FAILURE DETECTED. A REVIEW OF THE DOWNLOADED RECEIVER LOG DID NOT FIND ANY ERRORS RELATED TO THE CUSTOMER COMPLAINT. THE DEVICE WAS DETERMINED TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION. THE REPORTED EVENT OF AN RECOVERABLE LOSS OF ANTENNA WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682420 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-05 5191440 00386270000125

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR