BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNO INSET II 46/6 SC1 BLUE MCAN

    MDR report key: 19590410 · Received June 21, 2024

    Report

    Report Number
    3003442380-2024-09433
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    May 19, 2024
    Report Date
    June 21, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244020306
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1892562 - MDR 3003442380-2024-09433 - DEVICE 3 OF 3. E1 PATIENT CITY: (B)(4).

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE CANADA. IT WAS REPORTED ISSUES WITH 3 INFUSION SETS WHERE 2 INFUSION SETS FELL OFF AFTER 2 HOURS AND THE THIRD ONE FELL OFF AFTER 24 HOUR. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068232 UNO INSET II 46/6 SC1 BLUE MCAN MINIMED MIO FPA UNOMEDICAL A/S MMT-941A600 6000281 05705244020306

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown