BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLOOKO DEVICE SYSTEM

    MDR report key: 7898795 · Received September 21, 2018

    Report

    Report Number
    3009137498-2018-00005
    Event Type
    Malfunction
    Date Received
    September 21, 2018
    Date of Event
    August 21, 2018
    Report Date
    September 21, 2018
    Manufacturer
    GLOOKO INC
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A USER REPORTED THAT RECENT BLOOD GLUCOSE READINGS FROM THEIR BAYER CONTOUR NEXT ONE METER WERE NOT BEING TRANSFERRED TO THE GLOOKO MOBILE APPLICATION. AS A RESULT, THE USER WAS NOT ABLE TO ACCESS THE NEW BLOOD GLUCOSE READINGS ON THE GLOOKO APPLICATION. NO ADVERSE EVENT WAS REPORTED. THE GLOOKO ENGINEERING TEAM IS CURRENTLY INVESTIGATING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739187 GLOOKO DEVICE SYSTEM GLOOKO DEVICE SYSTEM NBW GLOOKO INC 5.0.3

    Patients

    Seq Age Sex Outcome Treatment
    1