BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 19534302 · Received June 13, 2024

    Report

    Report Number
    3004529019-2024-00571
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    May 31, 2024
    Report Date
    July 2, 2024
    Manufacturer
    TOSOH HI-TEC, INC.
    Product Code
    KHO
    UDI-DI
    04560189283992
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) CONDUCTED A SITE VISIT AND WAS ABLE TO CONFIRM THE ISSUE WHEN TRYING TO SET THE C-TRANS ARM BACK TO HOME BUT IT FAILED TO INITIALIZE. THE FSE TESTED THE HOME SENSOR, WHICH WAS WORKING AS INTENDED, SO THE FSE SUSPECTED THERE WAS A POSSIBLE MECHANICAL BINDING IN THE Z MOTOR. THE FSE REPLACED THE TEST CUP ASSEMBLY ARM, ALIGNED THE CUP TRANSFER ASSEMBLY, PERFORMED MULTIPLE CUP TRANSFER TESTS, THEN RAN QUALITY CONTROL (QC) WITH RESULTS WITHIN SPECIFICATIONS AND NO ISSUES RECURRING. THE AIA-900 ANALYZER IS FUNCTIONING AS EXPECTED. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW THROUGH AWARE DATE OF EVENT FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(6). THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE AIA-900 OPERATOR'S 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 WAS FAILURE OF THE TEST CUP PICKUP ASSEMBLY ARM DUE TO A POSSIBLE MECHANICAL BINDING IN THE CUP PICKUP Z MOTOR.

    Additional Manufacturer Narrative · 0

    THE TEST CUP PICKING ASSEMBLY UNIT WAS RETURNED TO THE TOSOH INSTRUMENT SERVICE CENTER (ISC) FOR EVALUATION. AN ISC TECHNICIAN PERFORMED A VISUAL INSPECTION WITH NO DAMAGE FOUND. THE TECHNICIAN THEN PERFORMED FUNCTIONAL TESTING VIA MANUAL OPERATION BY RUNNING CUP REMOVAL, CUP TRANSFER, LOADER CUP TRANSFER AND DAILY CHECK TESTS WITH ALL THE RESULTS PASSING. THE RETURNED PART MEETS SPECIFICATION. THE MOST PROBABLE CAUSE CANNOT BE ESTABLISHED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED 4151 (900 ONLY) C.TRANS-Z HOME DETECT ERROR ON THE AIA-900 ANALYZER. THE CUSTOMER VERIFIED THERE WAS NO OBSTRUCTION IN THE WASTE CHUTE. THE CUSTOMER STATES THE ANALYZER FAILS DAILY CHECK IN THE MIDDLE OF A RUN. A TOSOH TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO EMPTY TEST CUPS FROM THE MAINTENANCE SCREEN AND THE TEST CUPS WENT DOWN THE WASTE CHUTE; HOWEVER, THE ERROR PERSISTS. 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
    157669 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