BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20319026 · Received September 27, 2024

    Report

    Report Number
    3003442380-2024-27192
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    June 12, 2024
    Report Date
    August 29, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016620
    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 1991335 - MDR 3003442380-2024-27192 - DEVICE 1 OF 4 H11: SINCE NO LOT NUMBER IS AVAILABEL, 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 WOULD 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 12-JUNE-2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED 4 INFUSION SETS CANNULA KINKED EVENTS ON 12-JUNE-2024 AND 15-JUNE-2024 WITHIN 3 HOURS AFTER INSERTION. INFUSION SET WAS IN USE FOR LITTLE LESS THAN A DAY 18 HOURS. THE SITE OF INSERTION WAS 1 ON ARM, ALTERNATING BETWEEN ABDOMEN AND ARM. THE BLOOD GLUCOSE WAS REPORTED 400 - 420 MG/DL AND TREATED WITH MULTI-DAILY INJECTION (MDI) AND WALK. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. 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
    1492049 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 UNKNOWN 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female