BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 8406401 · Received March 9, 2019

    Report

    Report Number
    8031673-2019-00033
    Event Type
    Malfunction
    Date Received
    March 9, 2019
    Date of Event
    December 10, 2018
    Report Date
    July 22, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. DEVICE EVALUATED BY MANUFACTURER: THE AIA-900 INSTRUMENT, SERIAL NUMBER (B)(6), WAS RETURNED TO THE TOSOH INSTRUMENT SERVICE CENTER (ISC) FOR EVALUATION. FUNCTIONAL TESTING OF THE RETURNED AIA-900 INSTRUMENT DID NOT PASS; THE SAMPLE LOADER Y2 MOTOR WOULD NOT POWER ON AFTER A FIRST RUN. THE REPORTED EVENT WAS CONFIRMED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO A FAULTY SAMPLE LOADER Y2 MOTOR ON THE AIA-900 INSTRUMENT. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. A FIELD SERVICE ENGINEER ARRIVED AT THE SITE TO ADDRESS THE REPORTED EVENT AND PERFORM PREVENTIVE MAINTENANCE. THE FSE CONFIRMED THE REPORTED EVENT BY RUNNING A RACK ROTATION TEST; HOWEVER, COULD NOT FIND AN ISSUE WITH THE AIA-900 ANALYZER. THE FSE TURNED THE INVESTIGATION OVER TO A SR. FSE. THE SENIOR FSE REPRODUCED THE ERROR AND CONFIRMED THE ERROR VIA THE ERROR LOG. THE SR. FSE WAS ABLE TO OPERATE THE Y2-AXIS MOTOR FROM THE MAINTENANCE SOFTWARE WITHOUT ERROR. NEXT, SR. FSE REPLACED THE MB BOARD, THE MAIN BOARD AND THE SLD BOARD; HOWEVER, THE ISSUE PERSISTED. THE SR. FSE THEN CHECKED EVERY SENSOR ON THE SAMPLE LOADER, AND THE POWER SUPPLY AND NO ISSUES WERE NOTED. WHEN THE SR. FSE REPLACED THE MAIN BOARD THE SOFTWARE WAS LOADED WITHOUT INPUTTING THE SAVED PARAMETERS TO CHECK FOR CORRUPTED PARAMETER. THE DEVICE HAD PARTIAL FUNCTIONALITY AS THE CUSTOMER COULD RESET THE UNIT AFTER THE SAMPLES RAN AND LOAD ANOTHER RACK AND CONTINUE; HOWEVER, ONLY ONE RACK COULD RUN AT A TIME. THE SR. FSE ALSO ATTEMPTED TO RESOLVE THE ISSUE BY USING DIFFERENT COMBINATIONS OF THE 3 CIRCUIT BOARDS MB, MAIN, AND SLD BOARDS. NONE OF THE INTERVENTIONS RESOLVED THE REPORTED ISSUE. THE DECISION WAS FINALLY MADE TO DEINSTALL THE AIA-900 AND INSTALL A REPLACEMENT UNIT. A 13 MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(6) FROM NOV102017 THROUGH AWARE DATE (B)(4) 2018. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE AIA-900 OPERATOR'S MANUAL, UNDER CHAPTER 7- ERROR MESSAGES AND FLAGS WAS REVIEWED. 2322 S.RACK NOT FED FROM OUT POSIT. THE AIA-900 OPERATOR'S MANUAL INDICATES THAT THE 2322 S.RACK NOT FED FROM OUT POSIT ERROR MESSAGE IS GENERATED WHEN THE X1 END POINT RACK DETECTION SENSOR S076 DETECTS A RACK WHEN THE TAKE-OUT (Y2) BELT IS DRIVEN. THE OPERATOR IS INSTRUCTED TO CHECK TO SEE IF THERE IS ANY IMPEDIMENT TO THE SAMPLE RACK FEED. IF THE TROUBLE REOCCURS, CONTACT THE TOSOH LOCAL REPRESENTATIVES AND CHECK THE S076 AND THE TAKE-OUT BELT MECHANISM. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT HAS NOT YET BEEN DETERMINED; INVESTIGATION IS CURRENTLY IN PROCESS.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED TO A TOSOH FIELD SERVICE ENGINEER THAT THEY RECEIVED "2322 SAMPLE RACK NOT FED FROM OUT POSIT" ERRORS WITH THEIR AIA-900 ANALYZER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR LUTEINIZING HORMONE (LH II), ESTRADIOL (E2), AND BETA HUMAN CHORIONIC GONADOTROPIN (BHCG). THERE WAS 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
    199590 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1