BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 8075982 · Received November 15, 2018

    Report

    Report Number
    8031673-2018-05257
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    October 29, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SORTER PLARAIL CHAIN ASSEMBLY, ONE SPMD BOARD, ONE SORT BOARD, AND ONE PIQ BOARD WERE RETURNED FOR EVALUATION TO THE TOSOH INSTRUMENT SERVICE CENTER (ISC) WITH NO SHIPPING DAMAGE. FUNCTIONAL TESTING OF THE SORTER PLARAIL CHAIN ASSEMBLY FAILED. FUNCTIONAL TESTING OF THE SPMD BOARD, SORT BOARD, PIQ BOARD PASSED. THE REPORTED EVENT WAS DUPLICATED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS DUE TO A FAULTY SORT-5 TO SORB-1 GROUND CABLE. 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. INSPECTION OF THE DEVICE REVEALED THAT THE SORTER TIP MECHANISM WAS NOT WORKING. FSE PERFORMED THE TIP MACRO TEST, AND THE TIP DID NOT GO DOWN AND DID NOT PICK UP ANY TIPS. NO OBSTRUCTIONS WERE SEEN, BUT THE "Y" MOVEMENT WAS "NOT SMOOTH". FSE REPLACED THE SPMD BOARD WHICH IMPROVED THE "Y" MOVEMENT. NEXT, FSE PERFORMED A TIP MACRO TEST WITHOUT ISSUE UNTIL THE THIRD RACK, WHEN A LOW, SCREECHING, NOISE SOUNDED. FSE REPLACED THE SORT AND PLARAIL CHAIN ASSEMBLY, THE SORT BOARD AND WAS SUBSEQUENTLY ABLE TO PERFORM THE TIP MACRO TEST REPEATEDLY WITHOUT ERROR. THE CUSTOMER RAN QC WITHOUT ISSUE. WHEN FSE FOLLOWED UP WITH THE CUSTOMER THE NEXT DAY, THE CUSTOMER REPORTED THAT THEY WERE NOW RECEIVING "2207 NO TIP ACQUIRED BY SORTER" ERROR CODE. FSE RETURNED TO THE SITE TO CLEAN AND LUBRICATE THE TIP MECHANISM. THE CUSTOMER WAS SUBSEQUENTLY ABLE TO RUN THE TIP MACRO TEST AND 600 PATIENT SAMPLES 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 THE SERIAL NUMBER 10577205 FROM 29SEP2017 THROUGH AWARE DATE 29OCT2018. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE AIA-2000 OPERATOR'S MANUAL; CHAPTER10 - TROUBLESHOOTING - ERROR MESSAGES WAS REVIEWED. 4061 SORTER TIP PICKUP Z-AXIS HOME DETECTION FAILURE THE AIA-2000 OPERATOR'S MANUAL INDICATES THAT THE 4061 SORTER TIP PICKUP Z-AXIS HOME DETECTION FAILURE ERROR MESSAGE IS GENERATED WHEN 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). THE OPERATOR IS INSTRUCTED TO CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. 2207 NO TIP ACQUIRED BY SORTER THE AIA-2000 OPERATOR'S MANUAL INDICATES THAT THE 2207 NO TIP ACQUIRED BY SORTER ERROR MESSAGE IS GENERATED WHEN NO TIP WAS DETECTED DURING THE TIP ATTACHMENT CHECK. IF RETRY FAILS, MEASUREMENT RESULT WILL BE FLAGGED (MF FLAG). THE OPERATOR IS INSTRUCTED TO CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED "4061 SORTER TIP PICKUP Z-AXIS HOME DETECTION FAILURE" ERRORS WITH THEIR AIA-2000ST ANALYZER. THE CUSTOMER STATED THEY ATTEMPTED TO RUN QUALITY CONTROL (QC), BUT THE ERROR REOCCURRED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR BETA HUMAN CHORIONIC GONADOTROPIN (BHCG). 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
    914600 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1