BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6268028 · Received January 20, 2017

    Report

    Report Number
    3004753838-2017-06607
    Event Type
    Malfunction
    Date Received
    January 20, 2017
    Date of Event
    December 30, 2016
    Report Date
    December 30, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000279
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE G5 SYSTEM IS ASSOCIATED WITH PRODUCT CODE PQF.

    Additional Manufacturer Narrative · 1

    (B)(4) DESCRIBE EVENT OR PROBLEM - ADDITIONAL, DEVICE AVAILABLE FOR EVALUATION - ADDITIONAL, ADDITIONAL INFORMATION/DEVICE EVALUATION, DEVICE EVALUATED BY MANUFACTURER - ADDITIONAL, EVENT PROBLEM AND EVALUATION CODES - ADDITIONAL.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2016 THAT ON (B)(6) 2016, THE RECEIVER CEASED TO FUNCTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT WAS PROVIDED FOR EVALUATION. THE REPORTED EVENT OF RECEIVER CEASED TO FUNCTION COULD NOT BE CONFIRMED. A ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED. A REVIEW OF THE DATA LOG FOUND FIRMWARE ERRORS. THE REPORTED EVENT THAT THE RECEIVER CEASED TO FUNCTION WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. IN ADDITION TO THE RECEIVER, A UNIVERSAL SERIAL BUS (USB) POWER SUPPLY (PART NUMBER MT21255/ LOT NUMBER 2150806/ SERIAL NUMBER N/A) WAS RETURNED AND EVALUATED. LOAD TEST WAS PERFORMED AND NO DEFECT WAS FOUND. THE REPORTED EVENT OF AN ERROR ICON DISPLAY WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. ALSO A UNIVERSAL SERIAL BUS (USB) A TO UNIVERSAL SERIAL BUS (USB) MICRO B WIRE (PART NUMBER MT20655/ LOT NUMBER 2150804/ SERIAL NUMBER N/A) WAS RETURNED FOR EVALUATION. CABLE TESTING WAS PERFORMED AND NO DEFECT WAS FOUND. THE REPORTED EVENT OF AN ERROR ICON DISPLAY WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50074 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. MT22719-BLU 5219450 00386270000279

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR