BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM

    MDR report key: 5333572 · Received December 29, 2015

    Report

    Report Number
    3004753838-2015-64163
    Event Type
    Malfunction
    Date Received
    December 29, 2015
    Date of Event
    December 8, 2015
    Report Date
    December 8, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000187
    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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 5201170, BEING USED WITH THE COMPLAINT RECEIVER, WAS RETURNED ON 04/14/2016. THE RETURNED TRANSMITTER 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. THE DEVICE WAS DETERMINED TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION. THE REPORTED EVENT OF A PERMANENT OUT OF RANGE SIGNAL WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    PATIENT'S MOTHER 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 WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE DATA LOG WAS PROVIDED BY THE PATIENT. THE DATA WAS REVIEWED ON (B)(6) 2015 AND DIDN'T CONFIRM THE REPORTED EVENT OF UNRECOVERABLE LOSS OF ANTENNA PAST THRESHOLD. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856223 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM MDS MDS DEXCOM, INC. MT22608 5201389 00386270000187

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR