BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20093938 · Received August 29, 2024

    Report

    Report Number
    3003442380-2024-23001
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    January 25, 2024
    Report Date
    July 30, 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 1953606- MDR 3003442380-2024-23001- DEVICE 2 OF 15. 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 25-JAN-2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED INFUSION SET CANNULA KINKED EVENT WITHIN 3 HOURS AFTER INSERTION. THE SITE OF INSERTION WAS ABDOMEN AND LEG. THE BLOOD GLUCOSE WAS DISPLAYED HIGH AND TREATED WITH BOLUS AND INJECTION. 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
    271193 AUTOSOFT XC INSET I 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL A/S 1010899 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male