BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19728438 · Received July 12, 2024

    Report

    Report Number
    3003442380-2024-13722
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    January 1, 2023
    Report Date
    July 12, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018181
    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 1910171 - MDR 3003442380-2024-13722 - DEVICE 1 OF 10.

    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 THE PATIENT ENCOUNTERED INFUSION SET CANNULA WAS KINKED WITHIN 3 HOURS OF INSERTION FOR 10 INFUSION SETS. PATIENT BLOOD GLUCOSE AT THE TIME OF ISSUE WAS REPORTED AS HIGH AND PATIENT TOOK CORRECTION INJECTION VIA MDI TO ADDRESS HIGH BG. THE SITE OF INSERTION WAS ABDOMEN. THE ISSUE GOT RESOLVED BY REPLACING THE INFUSION SET AND RESUMED INSULIN DELIVERIES 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2346970 AUTOSOFT 90 UNO INSET II 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002819 UNKNOWN 05705244018181

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female