BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20459983 · Received October 16, 2024

    Report

    Report Number
    3003442380-2024-28610
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    August 16, 2024
    Report Date
    September 19, 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 2013042 - MDR 3003442380-2024-28610 - DEVICE 3 OF 3.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED THAT PATIENT FACED 3 INFUSION SETS CANNULA KINKED AFTER 3 HOURS OF INSERTION. INSERTION SITE WAS UPPER BUTTOCKS AND THIGH. THE BLOOD GLUCOSE LEVEL WAS HIGH. THEREFORE, PATIENT WAS TREATED WITH MULTIPLE DAILY INJECTION. CUSTOMER CONFIRMED THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION. CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. COMPANY 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
    2558791 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6005298 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male