BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 8003988 · Received October 25, 2018

    Report

    Report Number
    8031673-2018-00709
    Event Type
    Malfunction
    Date Received
    October 25, 2018
    Date of Event
    August 22, 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
    OH, 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 WASTE TUBING OF THE WASH PROBE #3 WAS LOOSE. FSE CUT BACK THE TUBING AND REINSERTED IT TO THE ASSEMBLY. THE ANALYZER WAS PRIMED WITHOUT ANY ISSUES AND THE DAILY CHECK RAN SUCCESSFULLY. IN ADDITION, THE CUSTOMER RAN QUALITY CONTROLS AND THE RESULTS WERE IN ACCEPTABLE RANGE. THE INSTRUMENT RAN WITHOUT ERRORS. THE PROBABLE CAUSE OF THIS EVENT WAS A LOOSE WASH PROBE #3. A 13-MONTH COMPLAINT AND SERVICE HISTORY REVIEW FOR AIA-2000LA ANALYZER SERIAL NUMBER (B)(4) FOR 21-JUL-2016 TO 22-AUG-2017 WAS PERFORMED FOR SIMILAR COMPLAINTS. THERE WERE NO OTHER SIMILAR COMPLAINTS FOUND IN THIS TIME FRAME. THE AIA-2000 OPERATOR'S MANUAL, CHAPTER 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 A PERSISTENT ERROR 2242 (WASH PROBE PURGE OVERFLOW) WITH THEIR AIA-2000 ANALYZER. THE CUSTOMER TRIED TROUBLESHOOTING BY CLEANING THE WASH PROBE, PRIMING, REBOOTING THE ANALYZER, AND PERFORMING VERSION UP, BUT THE ANALYZER DISPLAYED THE SAME ERROR. THE CUSTOMER REQUESTED SERVICE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING FOR LHII E2 PRL FSH BHCG PROGII AND CTNL2 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
    845597 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1