BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5788086 · Received July 12, 2016

    Report

    Report Number
    3004753838-2016-46067
    Event Type
    Malfunction
    Date Received
    July 12, 2016
    Date of Event
    June 14, 2016
    Report Date
    June 14, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT'S MOTHER 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. AT THE TIME OF CONTACT, NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF DEVICE EVALUATION. THE RECEIVER DATA LOG WAS REVIEWED ON 06/30/2016. THE COMPLAINT OF INACCURATE CGM VALUES WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT SENSOR WAS NOT RETURNED TO DEXCOM. THE TRANSMITTER (PART NUMBER STT-GF-001/SERIAL NUMBER (B)(4)/LOT NUMBER 5210262) WAS RETURNED ON 07/07/2016. THE RETURNED TRANSMITTER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND FAILED TESTING. THE REPORTED EVENT OF INACCURACIES WAS NOT CONFIRMED BECAUSE INFORMATION ABOUT INACCURACIES CANNOT BE OBTAINED FROM THE TRANSMITTER. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439201 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5211349 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR