BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLOOKO DEVICE SYSTEM

    MDR report key: 7648923 · Received June 28, 2018

    Report

    Report Number
    3009137498-2018-00002
    Event Type
    Malfunction
    Date Received
    June 28, 2018
    Date of Event
    June 8, 2018
    Report Date
    June 28, 2018
    Manufacturer
    GLOOKO INC
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A CLINIC REPORTED THAT THEY WERE UNABLE TO VIEW REMOTE DATA UPLOADED FROM A PATIENT'S INSULIN PUMP ON THE GLOOKO APPLICATION. THE CLINIC REPORTED THAT THE PATIENT INVOLVED WAS NEW TO THEIR INSULIN PUMP AND HAD PREVIOUSLY EXPERIENCED LOW BLOOD GLUCOSE LEVELS. NO ADVERSE EVENT WAS REPORTED. GLOOKO ENGINEERING INVESTIGATED THE ISSUE AND WAS ABLE TO REPRODUCED IT IN-HOUSE. A SOFTWARE UPDATE WAS IMPLEMENTED TO ADDRESS THE ISSUE AND THE INVESTIGATION WAS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488521 GLOOKO DEVICE SYSTEM GLOOKO WEB APPLICATION JQP GLOOKO INC 18.2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other