BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5338714 · Received December 31, 2015

    Report

    Report Number
    3004753838-2015-78270
    Event Type
    Malfunction
    Date Received
    December 31, 2015
    Date of Event
    December 5, 2015
    Report Date
    December 7, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000064
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONALLY THE TRANSMITTER ((B)(4)) THAT WAS USED WITH THE COMPLAINT DEVICE HAS BEEN RECEIVED FOR EVALUATION ON (B)(6) 2015 AND REPORTED SEPARATELY IN REPORT MFR NO. 3004753838-2015-78271.

    Description of Event or Problem · 1

    THE COMPLAINT RECEIVER DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED. A REVIEW OF THE DOWNLOADED RECEIVER LOG DID NOT FIND ANY ERRORS RELATED TO THE CUSTOMER COMPLAINT. A SENSOR (LOT NUMBER 5202626) WAS RETURNED; HOWEVER, AN INVESTIGATION WAS NOT PERFORMED ON THE DEVICE BECAUSE IT WAS DETERMINED TO BE UNNECESSARY AS IT IS UNRELATED TO THE ALLEGED COMPLAINT. ADDITIONALLY, THE TRANSMITTER BEING USED WITH THE COMPLAINT RECEIVER WAS RETURNED FOR EVALUATION. THE TRANSMITTER (PART NUMBER STT-GL-003/LOT NUMBER 5201956) 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

    STUDY COORDINATOR CONTACTED DEXCOM ON BEHALF OF THE PATIENT ON (B)(6) 2015 TO REPORT THAT ON (B)(6) 2015, THE PATIENT EXPERIENCED A PERMANENT OUT OF RANGE SIGNAL. THE COMPLAINT DEVICE HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861105 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649 140514405 00386270000064

    Patients

    Seq Age Sex Outcome Treatment
    1