BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4885941 · Received July 1, 2015

    Report

    Report Number
    3004753838-2015-05470
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 8, 2015
    Report Date
    June 8, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    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). THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE RECEIVER ((B)(4)) THAT WAS USED WITH THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION ON 06/30/2015. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). SUBSEQUENT TO THE INITIAL MDR, RETURNED PEDIATRIC RECEIVER (PART NUMBER STK-KD-BLU/(B)(4)/LOT NUMBER 5191408) WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS ATTEMPTED BUT UNABLE TO BE PERFORMED DUE TO THE RECEIVER NOT HOLDING CHARGE. THE RECEIVER CASE WAS OPENED FOR FURTHER EVALUATION AND THE BATTERY WAS CHARGED IN ORDER TO PERFORM A CALIBRATION AND PAIRING TEST. THE TEST FAILED AND CONFIRMED THE REPORTED EVENT OF A PERMANENT OUT OF RANGE SIGNAL. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE BATTERY.

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT THAT ON (B)(6) 2015, PATIENT EXPERIENCED A PERMANENT OUT OF RANGE SIGNAL. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428331 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-05 5193035

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR