BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 8082030 · Received November 16, 2018

    Report

    Report Number
    8031673-2018-05272
    Event Type
    Malfunction
    Date Received
    November 16, 2018
    Date of Event
    November 2, 2018
    Report Date
    December 17, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. THE SLV AND THE SORT BOARD WERE RETURNED FOR EVALUATION. BOTH BOARDS WERE INSTALLED AND FUNCTIONALLY TESTED BY RUNNING THE CUP AND TIP PICKUP SORTER MACROS SEVERAL TIMES IN AN EFFORT TO DUPLICATE THE INTERMITTENT SORTER ERRORS. THE PARTS FUNCTIONED AS INTENDED. PRECISION TESTING WAS ALSO PERFORMED IN AN EFFOR TO DUPLICATE THE ERROR. HOWEVER, ALL RESULTS WERE IN RANGE WITHOUT ANY ERRORS. THE PARTS PASSED TESTING. THE ERROR COULD NOT BE DUPLICATED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE PARTS FUNCTIONED AS INTENDED.

    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. H.3. DEVICE EVALUATION BY MANUFACTURER: A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING SERVICING, FSE REPLACED THE SLAVE ½ BOARD AND THE SORTER BOARD. FSE THEN RAN THE TIP PICK UP AND CUP PICK MACROS WITHOUT ANY FURTHER ERRORS. THE DAILY CHECK WAS PERFORMED AND PASSED. QUALITY CONTROLS (QC) WERE RUN BY THE CUSTOMER WITH ACCEPTABLE RESULTS. THE INSTRUMENT WAS OPERATING AS EXPECTED. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER 10577205 FROM 02-OCT-2017 THROUGH AWARE DATE 02-NOV-2018. THERE WERE NO SIMILAR COMPLAINTS FOUND DURING THE SEARCHED PERIOD. THE AIA-2000 OPERATOR'S MANUAL UNDER APPENDIX 4 - ERROR MESSAGES STATES THE FOLLOWING: [4063] SORTER TIP PICKUP Z-AXIS HOME OVERRUN CAUSE : THE HOME SENSOR ACTIVATED IMPROPERLY FOLLOWING MOVEMENT OF THE Z-AXIS SORTER TIP PICKUP. IF RETRY FAILS, THE MEASUREMENT RESULT WILL BE FLAGGED (MF FLAG). SOLUTION : CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. [4061] SORTER TIP PICKUP Z-AXIS HOME DETECTION FAILURE CAUSE : THE HOME SENSOR FAILED TO ACTIVATE AFTER THE SORTER TIP PICKUP Z-AXIS MOVED TOWARD THE HOME POSITION. 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 ERROR MESSAGES HAS NOT YET BEEN DETERMINED. THE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THEY WERE CONSTANTLY GETTING ERROR 4063 SORTER TIP PICKUP Z-AXIS HOME AND ERROR 4061 SORTER TIP PICKUP Z-AXIS HOME DETECTION FAILURE WITH THE AIA-2000ST INSTRUMENT. THERE WERE ABLE TO CLEAR THE ERRORS BUT THEY WOULD LATER RECUR. THE INSTRUMENT WAS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF ALPHA FETOPROTEIN (AFP) AND BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) 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
    918802 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1