BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 24274421 · Received February 5, 2026

    Report

    Report Number
    3004529019-2026-00011
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    January 13, 2026
    Report Date
    February 5, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER BY PHONE AND CONFIRMED THE REPORTED ISSUE WITH THE CUSTOMER. THE FSE INSTRUCTED THE CUSTOMER TO INSPECT THE CUP PICK UP CLAWS AND PRESENCE SENSOR. THE FSE THEN INSTRUCTED THE CUSTOMER TO CLEAN THE CUP PICK UP PRESENCE SENSOR AND PERFORM AN ALL SET HOME ACTION. THE CUSTOMER VALIDATED THE ANALYZER BY RUNNING A PATIENT SAMPLE, WITH NO ERRORS RECURRING. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE AIA-900 ANALYZER IS OPERATING AS EXPECTED. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW THROUGH AWARE DATE OF EVENT FOR SIMILAR COMPLAINTS WAS PERFORMED FOR FAILURE MODE "4151 (900 ONLY) C.TRANS-Z HOME DETECT ERROR". THERE WERE SEVENTEEN (17) SIMILAR COMPLAINTS FOUND DURING THE SEARCHED PERIOD, INCLUDING THIS ONE. THE AIA-900 OPERATORS MANUAL UNDER SECTION 12: FLAGS AND ERROR MESSAGES STATES THE FOLLOWING: [4151] C. TRANS-Z HOME DETECT ERROR. CAUSE: THE HOME SENSOR S062 FAILED TO BE ACTIVATED AFTER THE TRANSFER Y MOVED TOWARD THE HOME POSITION. 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 S062 AND PM061 FOR A POSSIBLE MALFUNCTION. THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE WAS DUE TO A DUST/DIRT PROBLEM OF THE CUP PICKUP PRESENCE SENSOR, CAUSE TRACED TO MAINTENANCE.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED 4151 C.TRANS-Z HOME DETECT ERROR ON THE AIA-900 ANALYZER. TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO INSPECTED THE WASTE AND CHUTE FOR OBSTRUCTIONS, NONE WERE FOUND. TSS THEN INSTRUCTED THE CUSTOMER TO PERFORM AN ALL SET HOME, WITH THE ERROR RECURRING. 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
    335597 AIA-900 FLUOROMETER, FOR CLINICAL USE KHO TOSOH HI-TEC, INC. AIA-900 04560189283992

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown