BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6033910 · Received October 17, 2016

    Report

    Report Number
    3004753838-2016-99747
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    September 21, 2016
    Report Date
    September 21, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000231
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2016, THAT ON (B)(6) 2016, THE RECEIVER DISPLAYED ERROR HW BBT NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE RECEIVER WAS RETURNED FOR EVALUATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. THE RECEIVER DATA LOG WAS DOWNLOADED AND REVIEWED AND FIRMWARE ERRORS WERE OBSERVED. THE REPORTED EVENT OF THE RECEIVER DISPLAYING ERROR HW BBT AND SCREEN ERROR ALARM WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684923 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. MT22719 5213219 00386270000231

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR