BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM

    MDR report key: 5505719 · Received March 16, 2016

    Report

    Report Number
    3004753838-2016-11027
    Event Type
    Malfunction
    Date Received
    March 16, 2016
    Date of Event
    February 17, 2016
    Report Date
    February 17, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. THE SENSOR WAS INSERTED ON (B)(6) 2016. 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 RECEIVER (PART NUMBER STK-DR-001 /SERIAL NUMBER (B)(4)/LOT NUMBER 5202797) WAS RETURNED ON 05/18/2016. THE RETURNED RECEIVER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED RELATED TO THE COMPLAINT. THE RECEIVER LOG WAS DOWNLOADED AND, UPON REVIEW, CONFIRMED THE REPORTED EVENT OF INACCURACIES. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    TWO TRANSMITTERS (SERIAL NUMBER (B)(4)) WAS RETURNED FOR EVALUATION. THE TRANSMITTER ((B)(4)) WAS VISUALLY INSPECTED AND NO DEFECTS WERE FOUND. A VOLTAGE TEST WAS PERFORMED AND THE TEST FAILED. BECAUSE THERE WAS NOT VOLTAGE. THE TRANSMITTER ((B)(4)) WAS VISUALLY INSPECTED AND NO DEFECTS WERE FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE TEST FAILED. A PAIRING TEST WAS PERFORMED AND THE TEST PASSED. THE REPORTED EVENT OF INACCURACIES COULD NOT BE CONFIRMED A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160912 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM MDS MDS DEXCOM, INC. 9500-27 ASKU 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR