BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 8095263 · Received November 21, 2018

    Report

    Report Number
    8031673-2018-05291
    Event Type
    Malfunction
    Date Received
    November 21, 2018
    Date of Event
    November 12, 2018
    Report Date
    January 1, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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: A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING SERVICING, FSE CONFIRMED TWO ENTRIES OF THE STC LANE MIXING FAILURE IN THE ERROR LOG. FSE REPLACED THE STC LANE. FSE RAN THE MACRO CUP TRANSFER WITHOUT ANY ISSUE. THE CUSTOMER RAN QUALITY CONTROLS (QC) WITH ACCEPTABLE RESULTS. THE INSTRUMENT WAS OPERATING AS EXPECTED. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. A 13-MONTH HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(6) FROM 12-OCT-2017 THROUGH 12-NOV-2018.. THERE WERE THREE (3) SIMILAR COMPLAINTS, INCLUDING THIS TICKET, IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-2000 OPERATOR'S MANUAL UNDER APPENDIX 4 - ERROR MESSAGES STATES THE FOLLOWING: [3061] STC LANE MIXING FAILURE CAUSE : THE MIXING CHECK SENSOR OF THE STC LANE MIXING MOTOR FAILED TO DETECT A MIXING OPERATION. THE CURRENT MEASUREMENT WILL BE FLAGGED (IO FLAG) AND NEW MEASUREMENTS WILL BE SUSPENDED. SOLUTION : CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. THE MOST PROBABLE CAUSE OF THE 3061 STC LANE MIXING FAILURE ERROR MESSAGE WAS FAILURE OF THE STC LANE.

    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. CORRECTION: DEVICE EVALUATION IN THE INITIAL SUBMISSION SHOULD HAVE INDICATED THAT DURING THE SERVICE EVALUATION, THE NEW STC LANE REPLACEMENT DID NOT RUN PROPERLY OUT OF THE BOX. AS A RESULT, THE PART AND A LOOSE BEARING WERE REMOVED AND A SECOND STC LANE ASSEMBLY WAS INSTALLED. THE SECOND STC LANE WORKED AS EXPECTED. ADDITIONAL INFORMATION: THE NEW STC LANE THAT FAILED OUT-OF-BOX WAS RETURNED FOR EVALUATION ON 28-NOV-2018. DEVICE EVALUATION BY MANUFACTURER: THE ORIGINAL STC LANE ASSEMBLY AND THE STC LANE ASSEMBLY THAT FAILED OUT-OF-BOX WERE RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED ON THE ORIGINAL PART FINDING THAT THE STC LANE MIXING ERRORS COULD NOT BE REPLICATED. PRECISION TESTING WAS PERFORMED IN AN EFFORT TO REPLICATE THE STC LANE MIXING ERROR BUT ALL RESULTS WERE IN RANGE. THE PART PASSED TESTING. THE STC LANE ASSEMBLY THAT FAILED OUT-OF-BOX WAS FUNCTIONALLY EVALUATED AND FOUND TO LOOSE CUP PLATFORM. THIS IS LIKELY WHAT COULD HAVE CAUSED THE STC LANE MIXING ERRORS OR PHYSICAL DAMAGE TO THE TEST BED. THE ERROR WAS DUPLICATED. THE PART FAILED TESTING. EVALUATION CODES: METHOD:4109 HISTORICAL DATA ANALYSIS; 10 TESTING OF ACTUAL/SUSPECTED DEVICE. RESULTS: 213 NO DEVICE PROBLEM FOUND. CONCLUSION CODE: 4315 CAUSE NOT ESTABLISHED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE PART FUNCTIONED AS INTENDED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED ERROR MESSAGE 3061 STC LANE MIXING FAILURE WITH THE AIA-2000 INSTRUMENT. THE INSTRUMENT WAS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) 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
    936456 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1