BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A1A-2000

    MDR report key: 7505702 · Received May 11, 2018

    Report

    Report Number
    8031673-2018-00434
    Event Type
    Malfunction
    Date Received
    May 11, 2018
    Date of Event
    April 26, 2018
    Report Date
    November 23, 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)(4) 2018, FIELD SERVICE ENGINEERING (FSE) VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING THE EVALUATION, FSE WAS ABLE TO CONFIRM THE COMPLAINT. TO RESOLVE THE ISSUE, THEY REPLACED THE WORN, LOOSE WASH SYRINGES WHICH WAS POSSIBLY CAUSING AIR TO ENTER THE WASH SYSTEM INTERMITTENTLY. THERE WAS ALSO EVIDENCE OF LEAKING ON THE BF INCUBATOR. FSE THEN REPLACED THE WASTE PUMP DUE TO BLACK DUST COMING OUT OF IT. THEY ALSO REPLACED THE WORN SUBSTRATE SYRINGE WHICH WAS SHOWING PLASTIC AT THE TOP. FSE WAS ABLE TO RUN CONTROLS WITH ACCEPTABLE RESULTS. THE INSTRUMENT WAS MADE READY FOR USE. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM (B)(6) 2017 THROUGH AWARE DATE (B)(6) 2018. THERE WAS ONE (1) SIMILAR COMPLAINT FOUND DURING THE SEARCHED PERIOD. THE AIA-2000 OPERATOR'S MANUAL UNDER CHAPTER 8, OTHER ASPECTS OF OPERATION STATES THE FOLLOWING: NO RESULT ( >H, <L ) THIS DETERMINES THE WAY IN WHICH DATA IS REPORTED INSTEAD OF CONCENTRATION WHEN THE ASSAY RESULT IS ">H" OR "<L.". THE TEST FILE ASSAY RANGE (UPPER LIMIT AND LOWER LIMIT) IS INCLUDED IN REPORTS WHEN ASSAY RANGE IS SELECTED. THE <", "> SYMBOLS ARE ADDED TO THE REPORT WHEN ASSAY RANGE (< >) IS SELECTED. IT ALSO FURTHER STATES THAT FOR <L RESULTS, CALCULATION FAILED DUE TO ASSAY RESULT BEING UNDER ASSAY RANGE (REPRESENTED BY ASSAY RANGE LOWER LIMIT VALUE IN TEST FILE). THE MOST PROBABLE CAUSE OF THE <L FLAG WAS DUE TO INTERMITTENT AIR IN THE BF WASH SYSTEM.

    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. ADDITIONAL INFORMATION: 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

    (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. DEVICE EVALUATION BY MANUFACTURER: TWO DRAIN PUMPS, TWO WASH SYRINGES, AND A SUBSTRATE SYRINGE WERE RETURNED AND EVALUATED ON 05/16/2018. FUNCTIONAL TESTING WAS PERFORMED WITH THE PARTS BUT THE <L FLAG COULD NOT BE DUPLICATED. THE QUALITY CONTROL RESULTS BEFORE AND AFTER THE PARTS WERE TESTED WERE ACCEPTABLE. ALL PARTS PERFORMED AS INTENDED. RESULTS CODE: 213 NO FAILURE DETECTED. CONCLUSION CODE: 71 NO FAILURE DETECTED; DEVICE OPERATED WITHIN SPECIFICATION. THE MOST PROBABLE CAUSE OF THE <L FLAG COULD NOT BE DETERMINED. THE PARTS PERFORMED AS INTENDED.

    Description of Event or Problem · 0

    ON (B)(6) 2018, A CUSTOMER REPORTED THAT THEY WERE GETTING <L FLAGS ON DIFFERENT ASSAYS BEING RUN FROM DIFFERENT LEVELS OF QUALITY CONTROL (QC) MATERIALS WITH THE A1A-2000 INSTRUMENT.. THEY ALSO GOT A <L FLAG FOR ALPHA FETOPROTEIN (AFP) ON LEVEL 1 QC. HOWEVER, WHEN THEY RE-RAN THE LEVEL 1 QC A SECOND TIME, THE AFP RESULT WAS 30. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH IN DELAYED REPORTING OF AFP 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
    350920 A1A-2000 A1A-2000 KHO TOSOH CORPORATION A1A-2000

    Patients

    Seq Age Sex Outcome Treatment
    1