BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER

    MDR report key: 7329959 · Received March 12, 2018

    Report

    Report Number
    8031673-2018-00199
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    February 16, 2018
    Report Date
    March 11, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 19-FEB-2018, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S FACILITY TO ADDRESS THE REPORTED ISSUE. FSE ADJUSTED THE SYS-INI SETTING FROM 110 TO 115, TIGHTENED BOTH OF THE SYRINGE PUMPS, RAN PRECISION, AND QC. ALL RESULTS PASSED WITHIN ACCEPTABLE RANGE AND THE FSE VERIFIED THE G8 INSTRUMENT WAS WORKING AS INTENDED. THE TOTAL AREA RESULTED IN NORMAL RANGE (TOTAL AREA OPTIMAL RANGE IS 700 TO 3000). NO FURTHER ACTION REQUIRED FROM FIELD SERVICE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SERIAL NUMBER (B)(4) FROM (B)(6) 2017 THROUGH (B)(6) 2018 FOR SIMILAR COMPLAINTS WAS PERFORMED. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE G8 OPERATOR'S MANUAL UNDER CHAPTER 1, INTRODUCTION AND APPLICATION, UNDER INTERPRETATION OF RESULTS, PROVIDES GUIDANCE ON THE TOTAL AREA AND CHROMATOGRAPHY. PARAGRAPHS THREE TO FIVE STATE " RESULTS WILL NOT BE REPORTED IF THE TOTAL AREA (TA) IS <500 WHICH CAN BE SEEN IN SEVERE ANEMIA. RESULTS WILL NOT BE REPORTED IF THE TA IS >4000 WHICH CAN BE SEEN IN POLYCYTHEMIA. (SEE "ABNORMAL RED CELL SURVIVAL IN PREVIOUS SECTION). THE OPTIMAL GOAL FOR TOTAL AREA IS BETWEEN 700-3000. HOWEVER A TA IN THE RANGE OF 500-4000 IS ACCEPTABLE AND REPORTABLE FOR WHOLE BLOOD SPECIMENS. THE CHROMATOGRAM MUST BE EXAMINED FOR ANY UNIDENTIFIABLE PEAKS (I.E., P00, P01,) BEFORE THE A0 PEAK. DO NOT REPORT THE RESULT IF THESE PEAKS EXIST. WHEN THERE IS A QUESTION CONCERNING THE CHROMATOGRAPHY, REPEAT THE SAMPLE. IF THE REPEATED SAMPLE ALSO DISPLAYS UNUSUAL CHARACTERISTICS, IT IS APPROPRIATE TO EVALUATE WHETHER THE UNUSUAL RESULT IS DUE TO AN ABNORMAL SAMPLE, A PROCEDURAL ERROR, AN INSTRUMENT MALFUNCTION OR A SAMPLE-HANDLING PROBLEM. FOR FURTHER INFORMATION, SEE THE TROUBLESHOOTING SECTION IN THIS OPERATOR'S MANUAL." IN ADDITION, CHAPTER 3 ASSAY OPERATIONS, UNDER DETAILED PEAK INFORMATION, THE OPTIMAL RANGE FOR TOTAL AREA IS 700 TO 3000. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO THE SMALL SYRINGE DRAW SETTING NEEDED TO BE ADJUSTED.

    Description of Event or Problem · 0

    ON (B)(6) 2018, CUSTOMER REPORTED GETTING LOW TOTAL AREA (THE TOTAL AREA OPTIMAL RANGE IS 700 TO 3000) WITH PATIENT SAMPLES ON THE G8 INSTRUMENT. CUSTOMER NOTED THE QUALITY CONTROLS (QC) WERE WITHIN ACCEPTABLE RANGE AND THE SAMPLE NEEDLE HAD BEEN REPLACED. ON 19-FEB-2018, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR HEMOGLOBIN A1C (HBA1C). 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
    174349 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1