BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 5507706 · Received March 17, 2016

    Report

    Report Number
    3004753838-2016-20827
    Event Type
    Malfunction
    Date Received
    March 17, 2016
    Date of Event
    February 17, 2016
    Report Date
    February 19, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    OYC
    UDI-DI
    00386270000019
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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) 2016 TO REPORT CONTINUOUS GLUCOSE MONITORING (CGM) INACCURACIES COMPARED TO BLOOD GLUCOSE (BG) METER THAT OCCURRED ON (B)(6) 2016. SENSOR WAS INSERTED ON (B)(6) 2016. IT WAS REPORTED THAT CALIBRATION WAS NOT PERFORMED CORRECTLY. THE T:SLIM G4 USER'S GUIDE STATES: MAKE SURE YOU DO NOT CALIBRATE WHEN "- - -" OR THE OUT OF RANGE ICON ARE ON THE SCREEN. AT THE TIME OF CONTACT, NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT SENSOR WAS NOT RETURNED TO DEXCOM. THE TRANSMITTER (PART NUMBER STT-GL-003/SERIAL NUMBER (B)(4)/LOT NUMBER 5203377, BEING USED WITH THE COMPLAINT SENSOR, WAS RETURNED ON 04/08/2016. 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 INACCURACIES WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163970 T:SLIM G4 SYSTEM OYC OYC DEXCOM, INC. 9500-27 ASKU 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR