BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7380225 · Received March 28, 2018

    Report

    Report Number
    8031673-2018-00238
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    March 1, 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: ON (B)(6) 2018, FSE WAS AT CUSTOMER'S SITE AND FOUND INTERMITTENT 4253 HYBRID ARM Z AXIS OVERRUN ERRORS. FSE REPLACED THE PULSE MOTOR DRIVER (PMD 2 BROAD), PERFORMED ALIGNMENTS AND ADJUSTMENT FOR THE HYBIRD ARM SET CUP BOTTOM AND BOTTLE BOTTOMS. FSE ADJUSTED Y AXIS INTO GLASS BOTTLE, CLEANED AND LUBRICATED Z AND Y AXIS, RESEATED HOME SENSOR PLUG, PRESSED IN CONNECTORS ON HYBRID ARM AND RESEATED ALL SLAVE BROADS. CUSTOMER RAN AND VERFIED CONTROLS SUCCESSFULLY WITHOUT ERRORS. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE AIA 2000LA INSTRUMENT IS FUNCTIONING AS INTENDED. INSTRUMENT WAS INSTALLED (B)(6) 2017, THEREFORE COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR AIA-2000LA, SERIAL NUMBER (B)(4), FROM (B)(6) 2017 THROUGH (B)(6) 2018. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-2000 OPERATOR'S MANUAL UNDER A4. APPENDIX 4: ERROR MESSAGES, STATES THE FOLLOWING: 4253: HYBRID ARM Z-AXIS HOME OVERRUN ERROR IS GENERATED WHEN THE HOME SENSOR ACTIVATED IMPROPERLY AFTER MOVEMENT OF THE HYBRID ARM Z-AXIS. IF RETRY FAILS, THE MEASUREMENT RESULT WILL BE FLAGGED MECHANICAL FAILURE (MF FLAG). THE SOLUTION IS FOR THE CUSTOMER TO CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. PMD BOARDS 2 PMD BOARDS (EACH FITTED WITH 15 PULSE MOTOR DRIVERS) ARE INSTALLED AT THE TOP LEVEL OF THE BOARD RACK. THE PMD1 BOARD IS IN THE HIGHEST RACK POSITION WHILE THE PMD2 BOARD IS IN THE SECOND HIGHEST POSITION. AS WITH THE SLV BOARDS, THESE ARE DIRECTLY CONNECTED TO THE MAIN BOARD BY DIN CONNECTORS. THE MOST LIKELY CAUSE OF THE REPORTED EVENT WAS DUE TO FAILED PMD2 BROAD.

    Additional Manufacturer Narrative · 0

    (B)(4), 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 NONCONFORMANCES, 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. CORRECTED DATA: IN THE INITIAL MDR SUBMISSION INCORRECTLY LISTED THE INSTALLATION DATE OF THE INSTRUMENT AS 28-JUN-2017. IT SHOUD HAVE BEEN 06-JULY-2017.

    Description of Event or Problem · 0

    ON (B)(6) 2018, A CUSTOMER REPORTED GETTING ERROR MESSAGE 4253 HYBRID ARM Z-AXIS OVERRUN ERRORS SIX TIMES TODAY ON THE AIA-2000LA INSTRUMENT. THE CUSTOMER STATED INSTRUMENT CONTINUES TO RUN BUT HAD TO RERUN THE SAMPLES THAT HAD ERRORS. 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 WAS 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
    220901 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1