BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6030252 · Received October 14, 2016

    Report

    Report Number
    3004753838-2016-84498
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    September 10, 2016
    Report Date
    September 10, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000279
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 09/10/2016 THAT ON (B)(6) 2016, THAT THE RECEIVER'S BUTTON(S) DO NOT RESPOND. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED FAULT COULD NOT BE REPRODUCED AND THERE WAS NO FAILURES RELATED TO THE CUSTOMER'S COMPLAINT. THE RECEIVER LOG WAS REVIEWED AND A SCREEN ERROR ALARM WAS OBSERVED. THE REPORTED EVENT OF RECEIVER BUTTON(S) DO NOT RESPOND WAS CONFIRMED DURING LOG REVIEW. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680991 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. MT22719-BLU 5218146 00386270000279

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR