BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20372303 · Received October 4, 2024

    Report

    Report Number
    3003442380-2024-26183
    Event Type
    Malfunction
    Date Received
    October 4, 2024
    Date of Event
    August 30, 2024
    Report Date
    November 6, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016620
    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 (B)(4).

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET TUBING DETACHMENT FROM HUB EVENT ON 30-AUG-2024, 31-AUG-2024 AND 1-SEP-2024. THE INFUSION SET WAS IN USE FOR ONE AND A HALF DAY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1443199 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6005474 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female