BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19826100 · Received July 25, 2024

    Report

    Report Number
    3003442380-2024-16250
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    June 4, 2024
    Report Date
    July 25, 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 1921598 - MDR 3003442380-2024-16250 - DEVICE 2 OF 7.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. ON 06-04-2024 IT WAS REPORTED THAT PATIENT FACED 7 INFUSION SETS CANNULA KINKED EVENT WITHIN 3 HOURS OF INSERTION. THE SITE WHERE INFUSION SET WAS INSERTED WAS ABDOMEN. BLOOD GLUCOSE AT THE TIME OF EVENT WAS 15.6 MMOL/L. 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. PATIENT REPLACED THE INFUSION SETS AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2302885 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 6002483 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female