BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 8003987 · Received October 25, 2018

    Report

    Report Number
    8031673-2018-00711
    Event Type
    Malfunction
    Date Received
    October 25, 2018
    Date of Event
    August 23, 2017
    Report Date
    October 25, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. THIS RECORD IS BEING SUBMITTED LATE AS PART OF A RETROSPECTIVE REVIEW PER (B)(4), COMPLAINT RETROSPECTIVE REVIEW AND REMEDIATION PROTOCOL. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, INSPECTED THE INSTRUMENT AND CONFIRMED THE FAILURE. THE FSE OBSERVED THE PROBE WAS MISSING THE INSERT. FSE REPLACED THE BF PROBE, PRIMED THE ANALYZER AND TESTED IT TO SPECIFICATIONS. THE INSTRUMENT WAS OPERATING WITH NO ERRORS. THE PROBABLE CAUSE OF THIS EVENT WAS A WORN BF PROBE. A 13 MONTH SERVICE HISTORY AND COMPLAINT HISTORY REVIEW WAS PERFORMED FOR AIA-2000ST ANALYZER SERIAL NUMBER (B)(4) FROM 23JUL2016 TO 23AUG2017. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE AIA-2000 OPERATOR'S MANUAL, CHAPTER 6 SYSTEM OPERATION, UNDER MAINTENANCE ROUTINE OUTLINES PRIMING THE SUBSTRATE LINE AND FLUSHING THE WASH SOLUTION COULD OUTPUT ERRORS WITH B/F PROBES 1 TO 4: PRIMING THE SUBSTRATE LINE. PRIME THE SUBSTRATE LINE WITH THE SUBSTRATE. FLUSH THE WASH SOLUTION. FLUSH OUT ANY WASH SOLUTION REMAINING IN THE WASH LINES. THE FOLLOWING ERROR MESSAGES APPEAR IF THE WASH SOLUTIONS ARE NOT PROPERLY FLUSHED. "2239: B/F PROBE 1 FLUSH FAILURE" APPEARS WHEN B/F PROBE 1 FLUSH FAILS. "2240: B/F PROBE 2 FLUSH FAILURE" APPEARS WHEN B/F PROBE 2 FLUSH FAILS. "2241: B/F PROBE 3 FLUSH FAILURE" APPEARS WHEN B/F PROBE 3 FLUSH FAILS. "2242: B/F PROBE 4 FLUSH FAILURE" APPEARS WHEN B/F PROBE 4 FLUSH FAILS. THESE MESSAGES INDICATE THAT AIR WAS NOT COMPLETELY FLUSHED FROM THE WASH SOLUTION LINES. IF ERRORS OCCUR, PRESS THE B/F PROBE KEY ON THE AIA-2000 SHEET KEY, OPEN THE COVER AND CHECK B/F UNIT FOR POSSIBLE CAUSES OF THE MALFUNCTION. AFTER THIS, CLICK PRIME WASH SOLUTION BUTTON ON THE OPERATION PANEL (TOOLBAR) TO REPEAT THE FLUSH PROCEDURE UNTIL THE LINES ARE FULL AND THE ERRORS STOP. CONTACT A TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES IF ERROR MESSAGES STILL APPEAR AFTER FLUSHING 5 TIMES OR MORE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED RECEIVING AN ERROR 2239 (B/F 1 PROBE PURGE FAILURE) WITH THEIR AIA-2000 ANALYZER. CUSTOMER STATED THAT THE WASH PROBE TIP WILL NOT STAY ON THE BF WASH PROBE #1 AND THAT THE TUBE THAT THE WASH PROBE TIP SLIPS TO IS NO LONGER ATTACHED TO THE PROBE ITSELF. CUSTOMER REQUESTED SERVICE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING FOR E2, FSH, BHCG, AFP, AND LHII 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
    845596 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1