BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 22812090 · Received August 14, 2025

    Report

    Report Number
    3004529019-2025-00007
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    July 18, 2025
    Report Date
    August 14, 2025
    Manufacturer
    TOSOH HI-TEC, INC.
    Product Code
    KHO
    UDI-DI
    04560189284616
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED ISSUE. THE FSE CONFIRMED THE REPORTED ISSUE BY REVIEW OF THE ERROR LOG. THE FSE HAD THE CUSTOMER CLEAN THE LEAK SENSOR S311 WITH COMPRESSED AIR DUE TO POSSIBLE DRIED WASH AFFECTING THE SENSOR, AND THE SENSOR IS NOW OPERATING AS EXPECTED. THE CUSTOMER ALSO NOTIFIED THE FSE THEY WERE GETTING ERROR 2239 B/F PROBE 1 PURGE FAILURE ERRORS AND NOTICED THE WASH SOLUTION WAS NOT BEING DELIVERED THROUGH B/F PROBE 1 DUE TO A DEFECTIVE SOLENOID VALVE SV290. THE FSE REPLACED THE SOLENOID VALVE SV290, THEN OBSERVED NORMAL WASH DELIVERY. THE FSE VALIDATED THE ANALYZER BY RUNNING A DAILY CHECK, QUALITY CONTROL (QC) AND PATIENT SAMPLES WITHOUT ERROR AND RESULTS WITHIN ACCEPTABLE RANGE. THE CUSTOMER FOLLOWED UP AT A LATER DATE AND NOTIFIED THE FSE THAT THE LEAK SENSOR S311 ERROR HAS RETURNED. THE FSE RETURNED TO THE CUSTOMER SITE AND CONFIRMED THE RECURRENCE. THE FSE DETERMINED THE POSSIBLE CAUSE WAS DUE TO AN INTERMITTENTLY OPERATING LEAK SENSOR S311 OR A DEFECTIVE LQD BOARD. THE FSE REPLACED THE LEAK SENSOR S311 AND THE LQD BOARD, THEN OBSERVED NORMAL LED OPERATION. THE FSE VALIDATED THE ANALYZER BY RUNNING A DAILY CHECK AND QUALITY CONTROL WITH RESULTS WITHIN ACCEPTABLE RANGE AND NO ERRORS RECURRING. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE AIA-2000 ANALYZER IS FUNCTIONING AS EXPECTED. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW THROUGH AWARE DATE OF EVENT FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER 10640701. THERE WERE NO OTHER SIMILAR COMPLAINTS FOUND DURING THE SEARCHED PERIOD. THE AIA-2000 OPERATORS MANUAL APPENDIX 4: ERROR MESSAGES STATES THE FOLLOWING: [3005] LEAK SENSOR DETECTED LEAKAGE. CAUSE : THE LEAK SENSOR UNDER B/F UNIT DETECTED LEAKAGE. MEASUREMENT IS SUSPENDED. SOLUTION : CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE WAS DUE TO A FAILURE OF THE LEAK SENSOR S311 AND THE LQD BOARD.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED ERROR 3005 LEAK SENSOR DETECTED LEAKAGE ON THE AIA-2000 ANALYZER. THE CUSTOMER STATED THE ERROR HAS OCCURRED MULTIPLE TIMES AND HAS POWERED OFF THE ANALYZER. THE ANALYZER IS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT WHICH RESULTED IN A DELAYED REPORTING OF PATIENT SAMPLES FOR BETA HUMAN CHORIONIC GONADOTROPIN (BHCG). THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956891 AIA-2000 FLUOROMETER, FOR CLINICAL USE KHO TOSOH HI-TEC, INC. AIA-2000 ST N/A 04560189284616

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown