BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19591597 · Received June 23, 2024

    Report

    Report Number
    3003442380-2024-09974
    Event Type
    Malfunction
    Date Received
    June 23, 2024
    Date of Event
    May 1, 2024
    Report Date
    December 15, 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 1894300 - MDR 3003442380-2024-09974 - DEVICE 3 OF 4.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED 4 INFUSION SET LEAKAGE AT THE SITE EVENT ON (B)(6) 2024. INFUSION SET HAS BEEN USED FOR LESS THAN 3 HOURS. INFUSION SET HAS BEEN USED FOR ONE DAY. THE BLOOD GLUCOSE LEVEL WAS 150-300MG/DL. CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068327 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6002403 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male