BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19902746 · Received August 4, 2024

    Report

    Report Number
    3003442380-2024-19015
    Event Type
    Malfunction
    Date Received
    August 4, 2024
    Date of Event
    June 18, 2023
    Report Date
    July 5, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016620
    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 1931562- MDR 3003442380-2024-19015- DEVICE 7 OF 7.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 18-JUNE-2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED SEVEN INFUSION SET CANNULA KINKED EVENT WITHIN 3 HOURS OF INSERTION. THE INFUSION SET WAS INSERTED IN ABDOMEN. THE PATIENT BLOOD GLUCOSE LEVEL WAS FOUND TO BE HIGH. 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
    376516 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 UNKNOWN 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male