BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5891762 · Received August 19, 2016

    Report

    Report Number
    3004753838-2016-80079
    Event Type
    Malfunction
    Date Received
    August 19, 2016
    Date of Event
    July 23, 2016
    Report Date
    July 23, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A UNIVERSAL SERIAL BUS (USB) (LOT NUMBER 2140436) ADAPTER WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS WERE FOUND. A LOAD TEST WAS PERFORMED AND THE TEST PASSED. THE REPORTED EVENT THAT THE AC ADAPTER WAS OVERHEATING WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. IT IS UNKNOWN IF THE RETURNED ACCESSORY IS THE COMPLAINT DEVICE.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2016, THAT ON (B)(6) 2016, THE PATIENT'S AC ADAPTER WAS OVERHEATING. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540068 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR