BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT 90

    MDR report key: 19557188 · Received June 18, 2024

    Report

    Report Number
    3003442380-2024-08929
    Event Type
    Injury
    Date Received
    June 18, 2024
    Date of Event
    May 14, 2024
    Report Date
    June 18, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018303
    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 1890714 - DEVICE 2 OF 5.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED KINGDOM. IT WAS REPORTED THAT THE PATIENT'S INFUSION SET FELL OFF DURING USE. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS 2.8 MMOL/L WHICH WAS TREATED BY PEN AND CONSUMING CARBOHYDERATES. THE ISSUE OCCURRED WITH FIVE SIMILAR TYPES OF INFUSION SETS USED FOR 24-48 HOURS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2323265 AUTOSOFT 90 UNO INSET II 60/6 BLUE TCAP 10PK INT FPA UNOMEDICAL A/S 1002823 5412131 05705244018303

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown