BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 20104732 · Received August 30, 2024

    Report

    Report Number
    3003442380-2024-23100
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    July 1, 2024
    Report Date
    July 31, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    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 1954847- MDR 3003442380-2024-23100- DEVICE 4 OF 5 SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATE IT WAS REPORTED THAT THE PATIENT EXPERIENCED CANNULA ISSUES WITH FIVE INFUSION SETS. THE CANNULAS WERE KINKED. THE EVENT OCCURRED BETWEEN 2024. PATIENT NOTICED SYMPTOMS WITHIN 3 HOURS OF INSERTION FOR ALL EVENTS. THE SITE OF INSERTION WAS THE ABDOMEN, UPPER BUTTOCKS, AND THIGH. PATEINT REGULARLY ROTATED SITE LOCATION. PATIENT CONFIRMED THAT THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION. BLOOD GLUCOSE LEVEL WAS 560 MG/DL AT THE TIME OF THE EVENT. THEREFORE, PATIENT TOOK CORRECTION INJECTION VIA MDI. 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
    1794903 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female