BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7278999 · Received February 16, 2018

    Report

    Report Number
    8031673-2018-00072
    Event Type
    Malfunction
    Date Received
    February 16, 2018
    Date of Event
    January 17, 2018
    Report Date
    August 30, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. DEVICE EVALUATION BY MANUFACTURER: ON (B)(6) 2018 A FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE MAIN ARM ON THE SAMPLING NOZZLE ASSEMBLY WAS HITTING THE SAMPLE TUBES AND TUBE GUARD AT THE BELT LINE POSITION. THE SAMPLING NOZZLE ASSEMBLY WAS ALSO HITTING THE TUBE GUARD AT THE FRONT LOADER POSITION WHENEVER THERE WAS LOW SAMPLE VOLUME. THE FSE REPLACED THE SAMPLING NOZZLE ASSEMBLY AND EKI-BOARD, ADJUSTED POSITION ON BELT LINE, ADJUSTED TRIMMER ON EKI-BOARD, AND TIGHTENED THE Y1-AXIS MAIN SLIDE TO REDUCE MOVEMENT IN THE X1-AXIS POSITION. THE FSE ALSO ADJUSTED THE TUBE GUARDS TO PREVENT THE THICK PART OF THE SAMPLING NOZZLE ASSEMBLY FROM HITTING IT. THE FSE THEN PROCEEDED TO RUN QUALITY CONTROLS, WHICH PASSED. NO FURTHER ACTION WAS REQUIRED BY THE FSE. THE AIA-2000 WAS OPERATING WITHIN SPECIFICATIONS. THE AIA-2000, SERIAL NUMBER (B)(4), WAS INSTALLED AT THE ACCOUNT ON (B)(6) 2017; COMPLAINT AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED ON (B)(6) 2017 THROUGH AWARE DATE (B)(6) 2018. THERE WERE NO SIMILAR EVENTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-2000 OPERATOR'S MANUAL UNDER A4. APPENDIX 4: ERROR MESSAGES STATES ADDRESSES ERROR MESSAGE 2016 AS FOLLOWS: 2066 FALSE DETECTION OF SPECIMEN LEVEL BY MAIN ARM CAUSE: THE LIQUID LEVEL WAS DETECTED BEFORE REACHING THE SURFACE OF THE SPECIMEN. IF RETRY FAILS, THE MEASUREMENT RESULT WILL BE FLAGGED (MF FLAG). SOLUTION: CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. THE MOST LIKELY CAUSE OF THE REPORTED EVENT WAS DUE TO FAULTY SAMPLING NOZZLE ASSEMBLY AND EKI-BOARD.

    Additional Manufacturer Narrative · 0

    H.10. ADDITIONAL MANUFACTURER NARRATIVE: 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. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR SERIAL NUMBER 80267204, WHICH CONFIRMED THAT THERE WERE NO NONCONFORMANCES, FAILURES, DISCREPANCIES, OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT. H.11 CORRECTED DATA: THE AIA-2000, SERIAL NUMBER 80267204, WAS INSTALLED AT THE ACCOUNT ON 06-JUL-2017; COMPLAINT AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FROM 06-JUL-2017 THROUGH AWARE DATE 17-JAN-2018. THERE WERE NO SIMILAR EVENTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-2000 OPERATOR'S MANUAL UNDER A4. APPENDIX 4: ERROR MESSAGES ADDRESSES ERROR MESSAGE 2066 AS FOLLOWS: 2066 FALSE DETECTION OF SPECIMEN LEVEL BY MAIN ARM CAUSE: THE LIQUID LEVEL WAS DETECTED BEFORE REACHING THE SURFACE OF THE SPECIMEN. IF RETRY FAILS, THE MEASUREMENT RESULT WILL BE FLAGGED (MF FLAG). SOLUTION: CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. F.9. APPROXIMATE AGE OF DEVICE

    Description of Event or Problem · 0

    ON (B)(6) 2018 A CUSTOMER REPORTED GETTING ERROR MESSAGE "2066 FALSE DETECTION OF SPECIMEN LEVEL BY MAIN ARM" ON THE AIA-2000 INSTRUMENT. THE CUSTOMER REPORTED THAT THE SAMPLING NOZZLE ASSEMBLY WAS HITTING THE SAMPLE TUBE WHEN SAMPLING FROM THE BELT LINE. THE CUSTOMER REQUESTED SERVICE IN ORDER TO FURTHER INVESTIGATE THE ISSUE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR ALPHA-FETOPROTEIN (AFP). THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119894 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1