BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19768614 · Received July 18, 2024

    Report

    Report Number
    3003442380-2024-14777
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    June 5, 2024
    Report Date
    July 18, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018334
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1914926 - MDR 3003442380-2024-14777 - DEVICE 1 OF 2.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED 2 INFUSION SET FELL OFF EVENT ON (B)(6) 2024. THE INFUSION SET WAS IN USE FOR OVER 24 HOURS THEN ABOUT 3 HOURS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352438 AUTOSOFT 90 UNO INSET II 60/9 BLUE TCAP 10PK INT FPA UNOMEDICAL A/S 1002824 5408218 05705244018334

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male