BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT 30

    MDR report key: 22553288 · Received July 21, 2025

    Report

    Report Number
    3003442380-2025-11769
    Event Type
    Injury
    Date Received
    July 21, 2025
    Date of Event
    June 1, 2025
    Report Date
    July 15, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018365
    PMA / PMN Number
    K061374
    Adverse Event
    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) HAS BEEN EVALUATED. THE BATCH 6009892 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3.0 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2.0 FOR THE CODE OCCLUSION (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). 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 3.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL FLOW TEST 1 ACCORDING TO WI VERSION 2.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6009892 WAS MANUFACTURED ACCORDING TO THE WI 4905501 VERSION 28 IN THE LINE 1 INSET 30, ON 20/OCT/2024, WITH A TOTAL OF 23,100 UNITS. SEALING BAG: THE LOT 4K03969 WAS MANUFACTURED ACCORDING TO THE WI VERSION 29 TUBE SEALING PROCESS IN THE MACHINE 213010 ON 18/OCT/2024, WITH A TOTAL OF 23,700 UNITS. GLUING OF TUBE THE LOT 4K02024 WAS MANUFACTURED ACCORDING TO THE WI VERSION 65.0 IN THE MACHINE SC07, ON 17/OCT/2024, WITH A TOTAL OF 24,400 UNITS. THE LOT 4K03968 WAS MANUFACTURED ACCORDING TO THE WI 4 VERSION 65.0 IN THE MACHINE SC07, ON 17/OCT/2024, WITH A TOTAL OF 1,900 UNITS. REVIEW OF THE DEVICE HISTORY RECORD (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 (B)(6) 2025 AGAINST MALFUNCTION OCCLUSION (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) AND LOT 6009892 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6009892 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 CANADA. IT WAS REPORTED THAT THE PATIENT WENT TO AN EMERGENCY ROOM (ER) AND EVENTUALLY GOT HOSPITALIZED ON (B)(6) 2025 AND WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. THE BLOOD GLUCOSE LEVEL WAS OVER 33.3 MMOL/L AT THE TIME OF EVENT AND WAS CAUSED BY THE OCCLUSION ALARM. THE PATIENT ALSO EXPERIENCED STOMACH FLU AND DEHYDRATION. PATIENT WAS FOUND POSITIVE FOR HIGH KETONES LEVEL AND KETONE LEVELS WERE FOUND TO BE LIFE-THREATENING. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2025. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737143 AUTOSOFT 30 UNO INSET 30 60/13 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002825 6009892 05705244018365

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Male Hospitalization| R