BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19559472 · Received June 18, 2024

    Report

    Report Number
    3003442380-2024-08849
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    April 9, 2024
    Report Date
    June 19, 2024
    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

    INITIAL AND FINAL MDR 1890788 - MDR 3003442380-2024-08849 - DEVICE 2 OF 2.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED STATES. IT WAS REPORTED THAT PATIENT FACED TWO INFUSION SET TUBING LEAKAGE EVENTS SINCE (B)(6) 2024. THE SET WAS IN USE FOR LESS THAN A DAY. BLOOD GLUCOSE LEVELS WERE 300-350 MG/DL AT THE TIME OF EVENT. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2310731 AUTOSOFT XC UNO INSET I 110/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001728 6003398 05705244016927

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male