BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLOOKO MOBILE APPLICATION FOR IOS

    MDR report key: 8787041 · Received July 12, 2019

    Report

    Report Number
    3009137498-2009-00007
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 13, 2019
    Report Date
    July 12, 2019
    Manufacturer
    GLOOKO INC
    Product Code
    PHV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A GLOOKO USER REPORTED THAT THE GLOOKO MOBILE APPLICATION FOR IOS WAS INCORRECTLY DISPLAYING RETROSPECTIVE "HIGH" AND "LOW" CGM VALUES. NO ADVERSE EVENT WAS REPORTED. THE GLOOKO ENGINEERING TEAM INVESTIGATED THE ISSUE AND A SOFTWARE FIX WILL BE IMPLEMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581053 GLOOKO MOBILE APPLICATION FOR IOS GLOOKO MOBILE APPLICATION FOR IOS PHV GLOOKO INC 5.5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other