BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM

    MDR report key: 4988726 · Received August 10, 2015

    Report

    Report Number
    3004753838-2015-80348
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 13, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE TRANSMITTER (B)(4) THAT WAS USED WITH THE DEVICE WAS RETURNED FOR EVALUATION ON (B)(6) 2015. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). SUBSEQUENT TO THE INITIAL MDR, THE RETURNED TRANSMITTER (PART NUMBER STT-GL-003/SERIAL NUMBER (B)(4)/LOT NUMBER 5201166), WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE TEST FAILED. THE REPORTED EVENT OF A PERMANENT OUT OF RANGE SIGNAL WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE TRANSMITTER.

    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
    522782 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM MDS MDS DEXCOM, INC. MT22608-BLU 5201275

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR