BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19677554 · Received July 5, 2024

    Report

    Report Number
    3003442380-2024-12233
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    May 6, 2024
    Report Date
    July 5, 2024
    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 1903446- MDR 3003442380-2024-12233- DEVICE 2 OF 8

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN(B)(6) IT WAS REPORTED THAT THE INFUSION SET'S TUBING WAS LEAKING AT SITE WITHIN LAST TWO WEEKS. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS 250 MG/DL.. MOREOVER, THE ISSUE OCCURRED WITH EIGHT INFUSION SETS USED BETWEEN ONE TO ONE AND HALF DAYS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472897 AUTOSOFT 90 UNO INSET II 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002819 5416054 05705244018181

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male