BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 30

    MDR report key: 21879795 · Received April 22, 2025

    Report

    Report Number
    3003442380-2025-06602
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    March 16, 2025
    Report Date
    June 13, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V
    Product Code
    FPA
    UDI-DI
    05705244014664
    PMA / PMN Number
    K061374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED MODEL NUMBER AND SERIAL NUMBER UNDER D4. 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 INVESTIGATION RELATED TO THIS COMPLAINT WAS CONDUCTED AND COMPLETED ON OCTOBER 19, 2023, UNDER THE PREVIOUS PROCEDURE. REFERENCE SAMPLES FROM LOT NO. 6000149 WERE TESTED AND DOCUMENTED IN TRACKWISE RECORD (B)(4) ON THE SAME DATE. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE BATCH RECORD 6000149 WAS VERIFIED AND IT WAS FOUND WITHIN SPECIFICATIONS. DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. TRENDING: A QUERY WAS RUN IN DATABASE ON 12-JUN-2025 AGAINST MALFUNCTION CODE 7 SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE AND LOT 6000149, WITH NO TREND IDENTIFIED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED ONE INFUSION SET CANNULA KINKED EVENT ON (B)(6) 2025. THE EVENT OCCURRED WITHIN 3 HOURS OF INSERTION. THE INSERTION SITE WAS THIGH. PATIENT 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 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
    1261306 AUTOSOFT 30 INSET 30 2-PACK 60/13 GREY TCAP FPA UNOMEDICAL DEVICES S.A. DE C.V 1002825 6000149 05705244014664

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female