BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5511017 · Received March 18, 2016

    Report

    Report Number
    3004753838-2016-33830
    Event Type
    Malfunction
    Date Received
    March 18, 2016
    Date of Event
    February 22, 2016
    Report Date
    February 22, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000279
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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

    THE UNIVERAL SERIAL BUS (USB) CABLE (LOT NUMBER 2132956) BEING USED WITH THE COMPLAINT RECEIVER DEVICE WAS RETURNED FOR EVALUATION ON 03/28/2016. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECTS WERE FOUND. CABLE TESTING WAS PERFORMED BY MEASURING THE USB CABLE PINS AND THE TESTS PASSED. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT RECEIVER DEVICE HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM ON (B)(6) 2016 TO REPORT THAT ON (B)(6) 2016, THE PATIENT'S RECEIVER DISPLAYED ERROR 67. AT THE TIME OF CONTACT, NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. THE RECEIVER LOG WAS REVIEWED AND SCREEN ERROR ALARMS AND FIRMWARE ERRORS WERE OBSERVED. THE REPORTED EVENT OF AN ERROR ICON DISPLAY WAS CONFIRMED DURING LOG REVIEW. A ROOT CAUSE COULD NOT BE DETERMINED. IN ADDITION,THE UNIVERSAL SERIAL BUS (USB) CABLE (LOT NUMBER 2132955) BEING USED WITH THE COMPLAINT RECEIVER DEVICE WAS RETURNED FOR EVALUATION ON 03/28/2016. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECTS WERE FOUND. CABLE TESTING WAS PERFORMED BY MEASURING THE USB CABLE PINS AND THE TESTS PASSED. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166225 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT22719-BLU 5205007 00386270000279

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR