BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19517476 · Received June 12, 2024

    Report

    Report Number
    3003442380-2024-07542
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    April 15, 2024
    Report Date
    June 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 1885048 - MDR 3003442380-2024-07542 - DEVICE 2 OF 2.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, THE PATIENT FACED THAT THE INFUSION SET CANNULA WAS KINKED WITHIN 3 OR MORE HOURS AFTER INSERTION AT ABDOMEN FOR 12 TO 24 HOURS, WHICH CAUSED THE PATIENT'S BLOOD GLUCOSE FROM LOW 200S MG/DL AND 350 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
    391462 AUTOSOFT 90 UNO INSET II 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002819 5390041 05705244018181

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male