BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFTÂ XC

    MDR report key: 19838496 · Received July 26, 2024

    Report

    Report Number
    3003442380-2024-16941
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    April 1, 2024
    Report Date
    July 26, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016682
    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 1922404 - MDR 3003442380-2024-16941 - DEVICE 1 OF 3.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED 3 INFUSIONS SET FELL OFF DURING USE ON EVENT ON 01-APRIL-2024. CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. INSERTION AREA WAS CLEANED, AIR DRIED AND FREE FROM HAIR. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914115 AUTOSOFTÂ XC UNO INSET I 60/6 PINK TCAP 10PK INT FPA UNOMEDICAL A/S 1001682 6002000 05705244016682

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female