BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 8075993 · Received November 15, 2018

    Report

    Report Number
    8031673-2018-05266
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    October 31, 2018
    Report Date
    January 3, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE STC LANE ASSEMBLY WAS RETURNED FOR EVALUATION TO THE TOSOH INSTRUMENT SERVICE CENTER (ISC) WITH NO SHIPPING DAMAGE. INSPECTION OF THE X-AXIS MOVEMENT OF STC LANE NOTED ROUGH SPOTS ALONG THE LANE FROM ANY COMBINATION OF THE FOLLOWING PARTS, DAMAGED BELT, FAULTY X-AXIS MOTOR (PM060) OR BROKEN LINEAR BEARING. THIS ROUGH X-AXIS MOVEMENT COULD LEAD TO MISALIGNMENT OF STC LANE OVER TIME, WHICH WOULD CAUSE CUP TRANSFER TO STC LANE ERRORS. THE STC LANE ASSEMBLY FAILED TESTING. THE REPORTED EVENT WAS DUPLICATED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FAILURE IS FAULTY X-AXIS MOTOR, BELT OR LINEAR BEARING. 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.

    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. FSE ARRIVED AT THE SITE TO ADDRESS THE REPORTED EVENT. FSE CONFIRMED THE ERROR BY RUNNING THE CUP TRANSFER MACRO. NEXT, FSE THE CLEANED THE SENSOR FLAG ASSEMBLY AND REPLACED THE STC LANE ASSEMBLY AFTER NOTING "MIXING MOTOR ASSEMBLY STALL" ERRORS CAUSED BY ELECTRIC WIRING IN THE PLARAIL CHAIN ASSEMBLY. THEN, FSE ALIGNED THE POSITIONS, RAN TWO CONSECUTIVE CUP TRANSFER MACROS, AND CLEANED THE TIP DISCARD SHUT AND STAINLESS STEEL. THE CUSTOMER WAS SUBSEQUENTLY ABLE TO RUN QUALITY CONTROL (QC) WITHOUT ISSUE. NO FURTHER ACTION WAS REQUIRED BY FIELD SERVICE. A 13 MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER 10058011 FROM 30SEP2017 THROUGH AWARE DATE 31OCT2018. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE AIA-2000 OPERATOR'S; CHAPTER8 - TROUBLESHOOTING - ERROR MESSAGES WAS REVIEWED. 2151 HYBRID ARM/ CUP TRANSFER PICKUP FAILURE THE AIA-2000 OPERATOR'S MANUAL INDICATES THAT THE 2151 HYBRID ARM/ CUP TRANSFER PICKUP FAILURE ERROR MESSAGE IS GENERATED WHEN THE S137 SENSOR FAILS TO DETECT A CUP AT THE HOME POSITION AFTER THE CUP PICKUP OPERATION. THE OPERATOR IS INSTRUCTED TO CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FAILURE OF THE STC LANE ASSEMBLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED "2151 HYBRID ARM PICKUP FAILURE" ERRORS ON THEIR AIA-2000ST ANALYZER. THE CUSTOMER PERFORMED A VERSION UP; HOWEVER, STATE THAT THE ERROR WAS INCREASING IN FREQUENCY. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR ALFA-FETA PROTEIN. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914812 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1