BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19835078 · Received July 26, 2024

    Report

    Report Number
    3003442380-2024-16384
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    June 14, 2024
    Report Date
    July 26, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016712
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1922579 - MDR 3003442380-2024-16384 - DEVICE 6 OF 8.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT, PATIENT FACED 8 INFUSION SET CANNULA KINKED EVENT ON (B)(6) 2024. THE SYMPTOMS WERE NOTICED WITHIN 3 HOURS OF INSERTION. THE SITE OF INSERTION WAS AT ABDOMEN. THE GLUCOSE LEVEL WAS HIGH AND THE PATIENT WAS TREATED WITH THE CORRECTION BOLUS VIA MULITIPLE DAILY INJECTION (MDI). UNOMEDICAL DO NOT SEE KINK 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 KINK SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534188 AUTOSOFT XC UNO INSET I 60/6 BLUE TCAP 10PK INT FPA UNOMEDICAL A/S 1001683 6005296 05705244016712

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female