BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 30

    MDR report key: 20460387 · Received October 16, 2024

    Report

    Report Number
    3003442380-2024-28815
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    August 25, 2024
    Report Date
    September 20, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018365
    PMA / PMN Number
    K061374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 2014192, DEVICE 2 OF 4. H11: SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS OR REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONCLUDED. 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 STATES. ON 09-SEPTEMBER-2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED 4 INFUSION SETS CANNULA DISLODGED EVENTS ON 01-SEPTEMBER-2024 AND 08-SEPTEMBER-2024 WITHIN 3 HOURS AFTER INSERTION. SITE OF INSERTION WAS ABDOMEN. THE BLOOD GLUCOSE LEVEL WAS REPORTED 600 MG/DL AND TREATED WITH MULTI-DAILY INJECTION (MDI). 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321662 AUTOSOFT 30 UNO INSET 30 60/13 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002825 UNKNOWN 05705244018365

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female