BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20513277 · Received October 23, 2024

    Report

    Report Number
    3003442380-2024-29025
    Event Type
    Malfunction
    Date Received
    October 23, 2024
    Date of Event
    September 14, 2024
    Report Date
    September 24, 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

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES ON (B)(6) 2024, IT WAS REPORTED THAT INFUSION WAS CANNULA WAS KINKED WITHIN 3 HOURS AFTER INSERTION. THE INFUSION SET WAS OIN USE FOR 4 HOURS. CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87602 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female