BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 22076135 · Received May 23, 2025

    Report

    Report Number
    3003442380-2025-09471
    Event Type
    Malfunction
    Date Received
    May 23, 2025
    Date of Event
    April 2, 2025
    Report Date
    July 25, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018273
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4) - DEVICE 1 OF 7.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR 2210757 - MDR 3003442380-2025-09471 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. THE BATCH 6007389 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2 FOR THE CODE LEAKAGE FROM CONNECTION BETWEEN THE TUBING CONNECTOR AND THE INFUSION SET (CANNULA PART/BASE PIECE). COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 3 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL AIR FLOW TEST 1 ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL AIR LEAK TEST 2 ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6007389 WAS MANUFACTURED ACCORDING TO THE WI VERSION 114 MANUFACTURED IN THE LINE L-10, LI103, ON 29/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; NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 19/JUN/2025 AGAINST MALFUNCTION CODE LEAKAGE FROM CONNECTION BETWEEN THE TUBING CONNECTOR AND THE INFUSION SET (CANNULA PART/BASE PIECE) AND LOT 6007389, 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 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 CANADA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVEN EVENTS WHERE THE INFUSION SET TUBING WAS LEAKING AT COUPLING HOUSING FROM (B)(6) 2025. THE INFUSION SET WAS IN USE FOR LESS THAN 48 HOURS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. 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
    972212 AUTOSOFT 90 UNO INSET II 60/9 PINK TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002822 6007389 05705244018273

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female