BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 30

    MDR report key: 19833346 · Received July 25, 2024

    Report

    Report Number
    3003442380-2024-16550
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    May 17, 2024
    Report Date
    July 25, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018396
    PMA / PMN Number
    K061374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1921407 - DEVICE 2 OF 4.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED 4 INFUSIONS SET TUBING LEAKAGE AT SITE EVENT ON 17-MAY-2024. INFUSION SET HAS BEEN USED FOR FEW HOURS TO SEVERAL DAYS. THE BLOOD GLUCOSE LEVEL AROUND 400MG/DL. CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215903 AUTOSOFT 30 UNO INSET 30 110/13 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002826 6004383 05705244018396

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female