BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP/GLOOKO

    MDR report key: 15310957 · Received August 26, 2022

    Report

    Report Number
    MW5111745
    Event Type
    Malfunction
    Date Received
    August 26, 2022
    Date of Event
    August 9, 2022
    Report Date
    August 24, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE INSULIN PUMP SETTINGS IN THE OMNIPOD DO NOT MATCH THE SETTINGS THAT ARE BEING DOWNLOADED TO GLOOKO IN BOTH THE OMNIPOD DASH AND OMNIPOD 5. THIS COULD CAUSE A PROVIDER TO OVER OR UNDER DOSE A CHILD WITH INSULIN. FDA SAFETY REPORT ID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147317 OMNIPOD INSULIN PUMP/GLOOKO ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Female