BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLOOKO DEVICE SYSTEM

    MDR report key: 7555254 · Received May 30, 2018

    Report

    Report Number
    3009137498-2018-00001
    Event Type
    Malfunction
    Date Received
    May 30, 2018
    Date of Event
    April 30, 2018
    Report Date
    May 30, 2018
    Manufacturer
    GLOOKO INC
    Product Code
    JQP
    PMA / PMN Number
    K130886
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER ALLEGES THE GLOOKO APPLICATION RUNNING ON THE (B)(4) TABLET WIPED A BLOOD GLUCOSE METER DATA CLEAN. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394575 GLOOKO DEVICE SYSTEM GLOOKO KIOSK APPLICATION JQP GLOOKO INC 2.6.1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other