BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19998526 · Received August 16, 2024

    Report

    Report Number
    3003442380-2024-21587
    Event Type
    Malfunction
    Date Received
    August 16, 2024
    Date of Event
    June 27, 2024
    Report Date
    August 18, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244014572
    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 1944847- MDR 3003442380-2024- 21587- DEVICE 1 OF 6.

    Description of Event or Problem · 0

    REFERENCE NUMBER 1944847. EVENT OCCURRED IN THE UNITED STATES. ON (B)(4) 2024, IT WAS REPORTED BY THE PATIENT THAT SIX INFUSIONS SET CANNULA WAS KINKED WITHIN 3 HOURS OF INSERTION. INFUSION SET WAS PLACED IN ABDOMEN AND ARM. EVENT OCCURRED ON (B)(4). PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. COMPANY 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
    1007353 AUTOSOFT 90 INSET II 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL A/S 1000282 6002402 05705244014572

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female