BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOOKO

    MDR report key: 22195834 · Received June 12, 2025

    Report

    Report Number
    MW5171400
    Event Type
    Injury
    Date Received
    June 12, 2025
    Date of Event
    May 30, 2025
    Report Date
    June 4, 2025
    Manufacturer
    GLOOKO, INC.
    Product Code
    PHV
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE REPORT FOR THE OMNIPOD 5 SYSTEM IN GLOOKO SHOWS 2 DIFFERENT INSULIN SETTINGS FOR THE SAME DEVICE. ENDOCRINOLOGIST USE THIS REPORT ALONG WITH BLOOD SUGAR LEVELS TO MAKE TREATMENT DECISIONS. OMNIPOD 5 SYSTEM IS USED AS AN INSULIN DELIVERY DEVICE. GLOOKO IS THE INTERNET BASED SOFTWARE THAT IS USED TO OBTAIN A REPORT ON THE CURRENT SETTINGS AND USAGE HISTORY. THE OFFICE CAN LOG IN, VIEW AND PRINT THE REPORTS. THESE REPORTS ARE USED IN THE OFFICE VISIT OR WHEN ANSWERING A PATIENT'S QUESTION REGARDING BLOOD SUGARS. REF REPORT: MW5171399.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552168 GLOOKO CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE PHV GLOOKO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention