BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 19590730 · Received June 22, 2024

    Report

    Report Number
    3003442380-2024-09366
    Event Type
    Injury
    Date Received
    June 22, 2024
    Date of Event
    May 23, 2024
    Report Date
    August 16, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016620
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4) - MDR 3003442380-2024-09366- DEVICE 2 OF 3.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR 1893416: CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY, THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED FOR THE MALFUNCTION CODE SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE. THE BATCH 6000610 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. THE REFERENCE SAMPLES FOR BATCH 6000610 WERE PREVIOUSLY TESTED IN 1792009 ON 02/DEC/2023. DEVICE HISTORY RECORD (DHR) REVIEW: PACKING LOT 6000610 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 104 IN THE LINE L-3, ON 24-MAY-2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 11/AUG/2025 AGAINST MALFUNCTION CODE SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE AND LOT 5389965 AND OTHER 3 COMPLAINTS HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 5389965 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: THIS IS A COMPLAINT WHICH IS BEING ADDRESSED AS PART OF A CORRECTIVE AND PREVENTIVE ACTION (CAPA) 1768101: "AUTOSOFT 90, KINKED SOFT CANNULA ISSUES WHICH HAS BEEN OPENED AS A RESULT OF TRENDING ACTIVITIES. THIS COMPLAINT IS A REPORTABLE WITH VALID LOT NUMBER/PRODUCT CODE

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 23 MAY 2024, IT WAS REPORTED THAT ON (B)(6) 2024, PATIENT EXPERIENCED INFUSION SET CANNULA WAS KINKED. WITHIN 3 OR MORE HOURS OF ABDOMEN AND THE HIP AREA INSERTION CUSTOMER NOTICED SYMPTOMS. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS 600 MG/DL. THEREFORE, THEY TRIED TO TREAT IT WITH CORRECTION BOLUS VIA PUMP AND MULTIPLE DAILY INJECTION. THE MULTIPLE EVENTS OCCURRED, FIRST HAPPENED ON (B)(6) 2024, SECOND ON (B)(6) 2024 AND THIRD ON (B)(6) 2024. ADDITIONALLY, THE PATIENT HAD MODERATE KETONES. ON (B)(6) 2024 PATIENT VISITED EMERGENCY ROOM FOR FEW HOURS AND TREATED WITH INTRAVENOUS (IV) AND FLUIDS OF SALINE AND INSULIN. UNOMEDICAL 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.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103253 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6000610 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention