BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 20245008 · Received September 18, 2024

    Report

    Report Number
    3003442380-2024-25713
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    June 17, 2024
    Report Date
    August 20, 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 1973730- MDR 3003442380-2024-25713- DEVICE 4 OF 10.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CANNULA ISSUES WITH TEN INFUSION SETS. THE CANNULAS WERE KINKED. THE EVENT OCCURRED ON 17-JUN-2024, 20-JUN-2024, 29-JUN-2024, 02-JUL-2024, 05-JUL-204, 17-JUL-2024, 26-JUL-2024, AND 08-AUG-2024. PATIENT NOTICED SYMPTOMS WITHIN 3 HOURS OF INSERTION. INFUSIONS SETS WERE USED FOR A FEW HOURS. PATIENT REPLACED THE INFUSION SETS 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
    1319585 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 6004244 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female