BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 20142344 · Received September 5, 2024

    Report

    Report Number
    3003442380-2024-23967
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    July 19, 2024
    Report Date
    November 25, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018181
    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 1960153 - MDR 3003442380-2024-23967 - DEVICE 1 OF 10.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT THE PATIENT FACED LEAKAGE FROM TUBING CONNECTS TO THE INFUSION SET CLIP EVENT ON 19-JULY-2024. THE INFUSION SET WAS IN USE FOR LESS THAN 1 DAY. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899243 AUTOSOFT 90 UNO INSET II 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002819 5416054 05705244018181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown