BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET

    MDR report key: 24614686 · Received March 17, 2026

    Report

    Report Number
    3003442380-2026-02820
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    February 19, 2026
    Report Date
    February 21, 2026
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K991759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SAUDI ARABIA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE EVENT ON (B)(6) 2026. PATIENT REPORTED THAT THE INFUSION SET WAS LEAKING AT SITE AFTER FEW HOURS OF USE. THE BLOOD GLUCOSE LEVEL WAS HIG, AND THE PATIENT WAS TREATED WITH PUMP. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684093 QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL UM-D MMT-399A 6013428 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown