BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19568357 · Received June 19, 2024

    Report

    Report Number
    3003442380-2024-09176
    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 - MDR 3003442380-2024-09176 - DEVICE 16 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
    641082 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