BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5128971 · Received October 5, 2015

    Report

    Report Number
    3004753838-2015-62113
    Event Type
    Malfunction
    Date Received
    October 5, 2015
    Date of Event
    September 14, 2015
    Report Date
    September 14, 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) 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

    SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT TRANSMITTER WAS NOT RETURNED TO DEXCOM. THE RECEIVER (PART NUMBER STR-GL-001/SERIAL NUMBER (B)(4)/LOT NUMBER 5191143), BEING USED WITH THE COMPLAINT TRANSMITTER, WAS RETURNED ON 10/03/215. THE RETURNED COMPLAINT DEVICE WAS VISUALLY INSPECTED AND NO DEFECTS WERE FOUND. A REVIEW OF THE RECEIVER DATA LOG CONFIRMED A HARDWARE ERROR CODE. THE ROOT CAUSE WAS DETERMINED TO BE A HARDWARE COMPONENT FAILURE.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658127 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-05 5197562 00386270000125

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR