BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 22085534 · Received May 27, 2025

    Report

    Report Number
    3003442380-2025-09916
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    May 11, 2025
    Report Date
    June 24, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244018150
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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) ACCORDING TO REFERENCE RESULTS COMPLAINT IS (B)(4) HAS BEEN EVALUATED. THE BATCH 6010454 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 OCCLUSION AT INFUSION SITE (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) (SPECIFIC CAUSE NOT IDENTIFIED). COMPLAINT INVESTIGATION: 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 WORK INSTRUCTION (WI) VERSION 3 ON REFERENCE SAMPLES, (B)(4) SAMPLES OUT (B)(4) SAMPLES PASSED THE TEST. FUNCTIONAL (FLOW TEST) TEST ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, (B)(4) SAMPLES OUT (B)(4) SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010454 WAS MANUFACTURED ACCORDING TO THE WI VERSION 120 PACKAGED IN THE INSET 6, ON 30/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING THE LOT 4L03514 WAS MANUFACTURED ACCORDING TO THE WI VERSION 65 IN THE GLUING OF TUBING IN THE MACHINE SC02, ON 27/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4L02361 WAS MANUFACTURED ACCORDING TO THE WI VERSION 08 IN THE GLUING OF TUBING IN THE MACHINE ITL01, ON 12/NOV/2024, 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 19/JUN/2025 AGAINST MALFUNCTION CODE OCCLUSION AT INFUSION SITE (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) (SPECIFIC CAUSE NOT IDENTIFIED) AND LOT 6010454. NO OTHER COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT NUMBER AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO HARM, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO OTHER COMPLAINT RECEIVED ON 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

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

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON 11-MAY-2025.THE BLOCKAGE WAS AT THE SITE. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715762 AUTOSOFT 90 UNO INSET II 110/6 GREY TCAP 10PK INT FPA UNOMEDICAL UM-D 1002818 6010454 05705244018150

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female