BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19444120 · Received June 1, 2024

    Report

    Report Number
    3003442380-2024-05403
    Event Type
    Malfunction
    Date Received
    June 1, 2024
    Date of Event
    April 23, 2024
    Report Date
    June 1, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016712
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED THAT PATIENT FACED INFUSION SET CANNULA KINKED EVENT. THE EVENT OCCURED AFTER 3 OR MORE HOURS OF INSERTION. THE INFUSION SET HAD BEEN USED FOR AROUND 7 HOURS. THE INSERTION SITE WAS AT THE ABDOMEN. THE BLOOD GLUCOSE LEVEL WAS 200-239 MG/DL AT THE TIME OF EVENT. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERY 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 WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865261 AUTOSOFT XC UNO INSET I 60/6 BLUE TCAP 10PK INT FPA UNOMEDICAL A/S 1001683 6003317 05705244016712

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male