BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19724471 · Received July 11, 2024

    Report

    Report Number
    3003442380-2024-13087
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    May 29, 2024
    Report Date
    July 9, 2024
    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) - DEVICE 1 OF 3.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT'S INFUSION SET FELL OFF DURING USE ON 29-MAY-2024, 30-MAY-2024 AND 31-MAY-2024. MOREOVER, THE ISSUE OCCURRED WITH THREE SIMILAR TYPES OF INFUSION SETS USED FOR ONE TO TWO DAYS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2426464 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6003170 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male