BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20154114 · Received September 6, 2024

    Report

    Report Number
    3003442380-2024-24198
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    June 10, 2024
    Report Date
    August 8, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016958
    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 1962250 - MDR 3003442380-2024-24198 - DEVICE 1 OF 2.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 10-JUNE-2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED TWO INFUSION SETS CANNULA KINKED EVENTS WITHIN 3 HOURS AFTER INSERTION. THE SITE OF INSERTION WAS ABDOMEN. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. 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
    1887641 AUTOSOFT XC UNO INSET I 110/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001729 6003937 05705244016958

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male