BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM

    MDR report key: 5251254 · Received November 25, 2015

    Report

    Report Number
    3004753838-2015-77578
    Event Type
    Malfunction
    Date Received
    November 25, 2015
    Date of Event
    November 5, 2015
    Report Date
    November 5, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION HAS BEEN COMPLETED. 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 5201938), BEING USED WITH THE COMPLAINT RECEIVER, WAS RETURNED ON (B)(6) 2015. THE RETURNED TRANSMITTER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE TESTS FAILED. THE REPORTED EVENT WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE TRANSMITTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779892 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM MDS MDS DEXCOM, INC. MT22608-BLU 5201938

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR