BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19674693 · Received July 4, 2024

    Report

    Report Number
    3003442380-2024-11755
    Event Type
    Malfunction
    Date Received
    July 4, 2024
    Date of Event
    May 30, 2024
    Report Date
    October 27, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018181
    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 (B)(4). DEVICE 3 OF 6

    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 WAS LEAKING AT SITE ON 30-MAY-2024, 31-MAY-2024 AND 02-JUN-2024. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS 12.2MMOL. MOREOVER, THE ISSUE OCCURRED WITH SIX SIMILAR TYPES OF INFUSION SETS USED FOR 24 HOURS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271396 AUTOSOFT 90 UNO INSET II 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002819 6002617 05705244018181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown