BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 24185510 · Received January 26, 2026

    Report

    Report Number
    3004529019-2026-00008
    Event Type
    Malfunction
    Date Received
    January 26, 2026
    Date of Event
    January 14, 2026
    Report Date
    January 26, 2026
    Manufacturer
    TOSOH HI-TEC, INC.
    Product Code
    KHO
    UDI-DI
    04560189283992
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 EVENT. THE FSE CONFIRMED THE ISSUE WITH THE CUSTOMER OVER THE PHONE. THE FSE INSTRUCTED THE CUSTOMER TO PERFORM AN ALL-SET-HOME, TURN THE ANALYZER OFF, OBSERVE THE SAMPLE NOZZLE, LUBRICATE THE SAMPLE NOZZLE GUIDE RAIL, SAMPLE NOZZLE SPRING AND Z-AXIS. THE FSE INSTRUCTED THE CUSTOMER TO TURN THE ANALYZER ON AND PERFORM DAILY OPERATIONS WHILE OBSERVING THE MOVEMENTS OF THE SAMPLE NOZZLE. AFTER OBSERVING THE SAMPLE NOZZLE MOVEMENTS, THE CUSTOMER WAS ABLE TO VERIFY THE RESOLUTION BY RUNNING DAILY OPERATIONS AND PATIENT SAMPLES WITHOUT ISSUES. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE AIA-900 ANALYZER IS FUNCTIONING AS EXPECTED. A COMPLAINT AND SERVICE HISTORY REVIEW FROM INSTALL DATE JANUARY 28, 2025 THROUGH THE AWARE DATE OF EVENT JANUARY 14, 2026 FOR SIMILAR COMPLAINTS WAS PERFORMED FOR FAILURE MODE "4123 (900 ONLY) SAMPLE-Z HOME OVERRUN" ON THE AIA-900 ANALYZER. THERE WERE FOUR SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD, INCLUDING THIS CASE. THE AIA-900 ANALYZER OPERATOR'S MANUAL UNDER SECTION 12: FLAGS AND ERROR MESSAGES STATES THE FOLLOWING: [4123] SAMPLE-Z HOME OVERRUN CAUSE: THE HOME SENSOR S052, WHICH IS NOT SUPPOSED TO BE ACTIVATED AFTER THE SPECIMEN DISPENSING ARM Z MOVES, WAS ACTIVATED. A RETRY WILL TAKE PLACE, AND IF THERE IS NO IMPROVEMENT A MF FLAG WILL BE ATTACHED TO THE MEASUREMENT RESULT. ACTION: PLEASE CONTACT TOSOH LOCAL REPRESENTATIVES. CHECK S052 AND ALSO CHECK TO SEE THE CAUSE OF SLIPPING, AND SO ON, THAT OCCURS WHEN PM051 MOVES TO THE LIMIT SIDE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO SAMPLE NOZZLE ASSEMBLY NEEDING LUBRICATION, CAUSE TRACED TO MAINTENANCE.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED "4123 SAMPLE-Z HOME OVERRUN" ERROR ON THE AIA-900 ANALYZER. THE CUSTOMER RESTARTED THE ANALYZER AND PERFORMED AN ALL-SET-HOME. THE ERROR OCCURS WHEN THE ANALYZER ATTEMPTS TO PICK UP A TIP FROM THE END OF THE TIP BOX. 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 PROGESTERONE (PROG II). 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
    246444 AIA-900 FLUOROMETER, FOR CLINICAL USE KHO TOSOH HI-TEC, INC. AIA-900 N/A 04560189283992

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown