BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19568361 · Received June 19, 2024

    Report

    Report Number
    3003442380-2024-09180
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Date of Event
    March 15, 2024
    Report Date
    June 20, 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 1891487. DEVICE 20 OF 20.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES, ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN 20 INFUSION LEAKING AT SITE LOCATION. THE INFUSION SET LONG FOR 1 TO 2 DAYS. THE BLOOD GLUCOSE LEVEL WAS 200-300 MG/DL. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672707 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 6000789 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female