BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5295936 · Received December 14, 2015

    Report

    Report Number
    3004753838-2015-63919
    Event Type
    Malfunction
    Date Received
    December 14, 2015
    Date of Event
    November 23, 2015
    Report Date
    November 24, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000125
    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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM ON (B)(6) 2015 TO REPORT THAT ON (B)(6) 2015, THE PATIENT EXPERIENCED A PERMANENT OUT OF RANGE SIGNAL. 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. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED PROBLEM COULD NOT BE REPRODUCED AND THERE WAS NO FAILURE DETECTED. THE ROOT CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM ON (B)(6) 2015 TO REPORT THAT ON (B)(6) 2015, THE PATIENT EXPERIENCED A PERMANENT OUT OF RANGE SIGNAL. SUBSEQUENT TO THE INITIAL MDR, THE RETURNED RECEIVER (PART NUMBER STK-DR-PNK/LOT NUMBER 5201403), BEING USED WITH THE COMPLAINT TRANSMITTER, WAS RETURNED ON 12/07/2015. THE RETURNED RECEIVER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED FAULT COULD NOT BE REPRODUCED AND THERE WAS NO FAILURE DETECTED. A REVIEW OF THE DOWNLOADED RECEIVER LOG DID NOT FIND ANY ERRORS RELATED TO THE CUSTOMER COMPLAINT. THE DEVICE WAS DETERMINED TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION. THE REPORTED EVENT OF AN INTERMITTENT OUT OF RANGE SIGNAL WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822843 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-05 5201194 00386270000125

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR