BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20448070 · Received October 15, 2024

    Report

    Report Number
    3003442380-2024-28468
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    August 14, 2024
    Report Date
    November 13, 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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 2011424 - MDR 3003442380-2024-28468 - DEVICE 1 OF 5.

    Description of Event or Problem · 0

    REFERENCE NUMBER(B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED FIVE INFUSION SET TUBING WAS BEND ON (B)(6) 2024. THE INFUSION SET WAS IN USE FOR 2-3 HOURS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324250 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6003157 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male