BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLOOKO WEB APPLICATION

    MDR report key: 10752087 · Received October 28, 2020

    Report

    Report Number
    3009137498-2020-00009
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    September 30, 2020
    Report Date
    October 28, 2020
    Manufacturer
    GLOOKO INC
    Product Code
    OUG
    PMA / PMN Number
    N/A#S-P#N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HCP USER REPORTED THAT CERTAIN SETTINGS FROM THE INSULET OMNIPOD DASH SYSTEM, THAT ARE UPLOADED TO THE GLOOKO DEVICE SYSTEM VIA AN INSULET CLOUD TO GLOOKO CLOUD CONNECTION, WERE NOT GETTING DISPLAYED ON THE GLOOKO WEB APPLICATION. NO ADVERSE EVENTS WERE REPORTED. THE GLOOKO ENGINEERING TEAM WAS ABLE TO REPRODUCE THE ISSUE AND A SOFTWARE CHANGE WAS IMPLEMENTED. PRIOR TO THE GLOOKO SOFTWARE CHANGE, A WORKAROUND WAS PROVIDED TO THE AFFECTED USERS VIA A MANUAL UPLOAD USING INSULET'S USB CABLE INSTEAD OF THE CLOUD TO CLOUD CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216059 GLOOKO WEB APPLICATION GLOOKO WEB APPLICATION OUG GLOOKO INC 20.5.1

    Patients

    Seq Age Sex Outcome Treatment
    1