BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19759726 · Received July 17, 2024

    Report

    Report Number
    3003442380-2024-14993
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    May 22, 2024
    Report Date
    July 17, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018211
    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 1914932- MDR 3003442380-2024-14993- DEVICE 4 OF 4.

    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 ENCOUNTERED FOUR INFUSION SET CANNULAS KINKED EVENT WITHIN 3 HOURS OF INSERTION. THE INFUSION SET WAS IN USE FOR 6 HOURS. PATIENTS' BLOOD GLUCOSE LEVEL WAS FOUND TO BE 400MG/DL. PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718533 AUTOSOFT 90 UNO INSET II 110/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002820 UNKNOWN 05705244018211

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male