BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7602890 · Received June 14, 2018

    Report

    Report Number
    8031673-2018-00553
    Event Type
    Malfunction
    Date Received
    June 14, 2018
    Date of Event
    May 29, 2018
    Report Date
    December 18, 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. DEVICE EVALUATION BY MANUFACTURER: FIELD SERVICE ENGINEERING (FSE) VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING THE EVALUATION, FSE CONFIRMED THE ERROR IN THE ERROR LOG. FSE REPLACED THE EKI BOARD FOR LEVEL SENSING ON THE MAIN ARM. FSE THEN ADJUSTED THE LIQUID ADC VALUE TO 724 WITH POT ON BOARD. FSE ALSO PERFORMED K1 CALCULATION FOR CLOT DETECTION DUE TO THE NEW EKI BOARD. THE NEW K1 WAS 311 PUT IN THE PO5 FILE. FSE RAN QUALITY CONTROL WITH ACCEPTABLE RESULTS. THERE WERE NO FURTHER ERRORS REPORTED. THE INSTRUMENT WAS VERIFIED AS OPERATIONAL. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. THE INSTRUMENT WAS INSTALLED ON 06-JUL-2017. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL (B)(4) FROM 06-JUL- 2017 THROUGH (B)(6) 2018. THERE WAS ONE (1) SIMILAR COMPLAINT IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-2000 OPERATOR'S MANUAL UNDER APPENDIX 4 - ERROR MESSAGES STATES THE FOLLOWING: [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 PROBABLE CAUSE OF THE 2066 FALSE DETECTION OF SPECIMEN LEVEL BY MAIN ARM ERROR MESSAGE FAULT OR FAILURE OF THE MAIN ARM.

    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. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR SERIAL NUMBER (B)(4), WHICH CONFIRMED THAT THERE WERE NO NON-CONFORMANCES, FAILURES, DISCREPANCIES, OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT.

    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. THE EKI BOARD WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED USING A MULTIMETER AND NO PROBLEMS WERE NOTED WITH CONTINUITY. FUNCTIONAL TESTING WAS PERFORMED BY CHECKING LIQUID AD. ALL LIQUID AD VALUES WERE WITHIN RANGE. THE ERROR COULD NOT BE DUPLICATED. THE PART PASSED TESTING.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED ERROR MESSAGE ERROR 2066 FALSE DETECTION OF SPECIMEN LEVEL BY MAIN ARM ON CONTROL IN CUPS WITH THE AIA-2000 INSTRUMENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF BETA HUMAN CHORIONIC GONADOTROPIN (BHCG), HUMAN CHORIONIC GONADOTROPIN (HCG), AND ALPHA FETOPROTEIN (AFP) PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445967 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1