BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFTÂ XC

    MDR report key: 19970558 · Received August 13, 2024

    Report

    Report Number
    3003442380-2024-20272
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    April 16, 2024
    Report Date
    November 8, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016927
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - DEVICE 1 OF 2.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THIS MDR IS BEING SUBMITTED FOR AN UNKNOWN NUMBER OF DEVICES IN WHICH THE ISSUE WAS EXPERIENCED. IT WAS REPORTED THAT PATIENT FACED 2-3 BOXES OF INFUSIONS SET TUBE LEAKAGE EVENT ON (B)(6) 2024. INFUSION SET HAS BEEN USED FOR 2 DAYS. THE BLOOD GLUCOSE LEVEL WAS OVER 250-380 MG/DL. CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2174344 AUTOSOFTÂ XC UNO INSET I 110/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001728 6000707 05705244016927

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male