BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 20341956 · Received October 1, 2024

    Report

    Report Number
    3003442380-2024-25829
    Event Type
    Injury
    Date Received
    October 1, 2024
    Date of Event
    August 20, 2024
    Report Date
    September 10, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244026001
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 2002897 - MDR 3003442380-2024-25829- DEVICE 3 OF 3. H11: 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 POST MARKETING SURVEILLANCE (PMS) PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WOULD FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE ON MARKET QUALITY REVIEW (OMQR) PROCEDURE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, REPORTED THAT PATIENT FACED 3 INFUSION SETS CANNULA BENT AFTER 3 OR MORE HOURS OF INSERTION. INFUSION SET HAS BEEN USED FOR ONE DAY. THE BLOOD GLUCOSE LEVEL WAS 641 MG/DL. THEREFORE, PATIENT WAS TREATED WITH CORRECTION BOLUS VIA PUMP AND MULTIPLE DAILY INJECTION. HOSPITAL WAS THIRD ASSISTANCE PARTY FOR PATIENT. PATIENT HAVING KETONE LEVEL. CUSTOMER 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 AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45584 AUTOSOFT XC INSET I 2-PACK 60/6 GREY TCAP FPA UNOMEDICAL A/S 1010900 UNKNOWN 05705244026001

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention