BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 30

    MDR report key: 19848478 · Received July 28, 2024

    Report

    Report Number
    3003442380-2024-17642
    Event Type
    Malfunction
    Date Received
    July 28, 2024
    Date of Event
    April 21, 2024
    Report Date
    July 28, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    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 1925126 - MDR 3003442380-2024-17642 - DEVICE 3 OF 5

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT FACED 5 INFUSION SET CANNULA KINKED EVENT ON 21-APRIL-2024 AFTER 3 OR MORE HOURS OF INSERTION. INFUSION SET HAS BEEN USED FOR 2-3 DAYS. INSERTION SITE WAS ABDOMEN. CUSTOMER REGULARLY ROTATE SITE LOCATION. THE GLUCOSE LEVEL WAS 20MMOL/L AND OTHERS BETWEEN 11-19 MMOL/L. FURTHERMORE, CUSTOMER CONFIRMED THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION. CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN 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 AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1586813 AUTOSOFT 30 UNO INSET 30 60/13 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002825 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female