BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 20703773 · Received November 18, 2024

    Report

    Report Number
    3003442380-2024-31911
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    October 5, 2024
    Report Date
    October 21, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244014541
    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 2042951 (B)(4). DEVICE 1 OF 2.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CANNULA ISSUES WITH TWO INFUSION SETS. THE CANNULAS WERE KINKED. THE EVENT OCCURRED ON (B)(6) 2024. PATIENT NOTICED SYMPTOMS WITHIN 3 OR MORE HOURS AFTER INSERTION. THE INSERTION OF SITE WAS THE ABDOMEN. INFUSION SETS WERE USED FOR 3-4 HOURS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES 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
    2604333 AUTOSOFT 90 INSET II 2-PACK 60/6 GREY TCAP FPA UNOMEDICAL A/S 1000281 6005340 05705244014541

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male