BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLOOKO WEB PORTAL

    MDR report key: 22308100 · Received June 23, 2025

    Report

    Report Number
    MW5171748
    Event Type
    Malfunction
    Date Received
    June 23, 2025
    Date of Event
    June 11, 2025
    Report Date
    June 11, 2025
    Manufacturer
    GLOOKO INC
    Product Code
    PHV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS PATIENT WEARS AN OMNIPOD 5 INSULIN PUMP. THE SETTINGS IN HIS GLOOKO REPORT WERE DIFFERENT THAN THE SETTINGS ON HIS OMNIPOD CONTROLLER. THIS COULD LEAD TO INSULIN BEING DOSED INCORRECTLY AND THE HEALTH CARE PROVIDER ORDERING THE INSULIN FOR THE PUMP TO MAKE INACCURATE CLINICAL DECISIONS. SETTINGS SEEN IN THE WEB PORTAL GLOOKO. PATIENT CODE: 4582. DEVICE CODE: 2919. REFERENCE REPORT#: MW5171749.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2064135 GLOOKO WEB PORTAL CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE PHV GLOOKO INC

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male Other HUMALOG. THERAPY START DATE: