BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19576667 · Received June 20, 2024

    Report

    Report Number
    3003442380-2024-09230
    Event Type
    Malfunction
    Date Received
    June 20, 2024
    Date of Event
    December 9, 2023
    Report Date
    June 20, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016682
    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 1892888 - MDR 3003442380-2024-09230 - DEVICE 5 OF 15.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2023, THE PATIENT REPORTED THAT THE INFUSION SET CANNULA WAS KINKED WITHIN 3 OR MORE HOURS AFTER INSERTION ON UPPER BUTTOCKS, WHICH CAUSED THE PATIENT BLOOD GLUCOSE LEVELS TO 300-450 MG/DL. THE PATIENT 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
    2194174 AUTOSOFT XC UNO INSET I 60/6 PINK TCAP 10PK INT FPA UNOMEDICAL A/S 1001682 UNKNOWN 05705244016682

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female