BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 20275046 · Received September 21, 2024

    Report

    Report Number
    3003442380-2024-26313
    Event Type
    Malfunction
    Date Received
    September 21, 2024
    Date of Event
    July 22, 2024
    Report Date
    August 23, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018129
    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 (B)(4).

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CANNULA ISSUES WITH EIGHT INFUSION SETS. THE CANNULAS WERE KINKED. THE EVENT OCCURRED ON 22-JUL-2024, 25-JUL-2024, 31-JUL-2024, 06-AUG-2024, 11-AUG-2024, 14-AUG-2024, AND 15-AUG-2024. INFUSION SETS WERE USED FOR A FEW 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
    1668023 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 6005316 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown