BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19685442 · Received July 6, 2024

    Report

    Report Number
    3003442380-2024-12321
    Event Type
    Malfunction
    Date Received
    July 6, 2024
    Date of Event
    May 25, 2024
    Report Date
    July 6, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018129
    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 1904646 - MDR 3003442380-2024-12321 - DEVICE 1 OF 2.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT ENCOUNTERED TWO SIMILAR EVENTS WHERE TWO INFUSION SETS FELL OFF DURING USE, ON (B)(6) 2024. AFTER BEING USED FOR LESS THAN 6 HOURS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477041 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 UNKNOWN 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male