BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7532405 · Received May 22, 2018

    Report

    Report Number
    8031673-2018-00470
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    May 4, 2018
    Report Date
    May 22, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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: FIELD SERVICE ENGINEERING (FSE) CONDUCTED A SERVICE CALL WITH THE CUSTOMER OVER-THE-PHONE TO ADDRESS THE REPORTED EVENT. DURING TROUBLESHOOTING, THE CUSTOMER REPORTED THAT THEY WERE GETTING RETENTION TIMES (RT) OF 0.53 WITH WHOLE BLOOD SAMPLES. THE CUSTOMER STATED THAT THEY WERE PREVIOUSLY GETTING A FLOW FACTOR OF 1.15 WHICH CHANGED TO 1.50 AFTER CHANGING THE COLUMN. FSE CALCULATED A NEW FLOW FACTOR OF 1.10 AND INSTRUCTED THE CUSTOMER TO CHANGE THE FLOW FACTOR (FF) TO 1.10 AND TO RUN 5 WHOLE BLOOD SAMPLES. THE CUSTOMER RECEIVED GOOD CHROMATOGRAMS WITH RTS OF 0.59 WITH THE ADJUSTED FF 1.10. FSE THEN INSTRUCTED THE CUSTOMER TO CALIBRATE, RUN PRECISION, AND THEN RUN QUALITY CONTROL (QC). THE CALIBRATION PASSED WITH NO ERRORS. THE PRECISION PASSED WITH COEFFICIENT OF VARIATION (CV) <=2.0%: PRECISION MEAN: 5.892%, STANDARD DEVIATION (SD): 0.029, CV: 0.49%, STRECK QC LOT # 7324 WAS WITHIN ASSAY INSERT RANGES. LEVEL 1 RESULT 5.1 (RANGE 4.2-6.2), LEVEL 2 RESULT 9.9( RANGE: 7.8-11.8). THE INSTRUMENT WAS VERIFIED AS OPERATIONAL. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. A 13 MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED ON 19-MAY-2018 FOR G8 INSTRUMENT WITH SERIAL NUMBER (B)(4). THE SEARCH WAS CONDUCTED FROM 04-APR-2017 THROUGH AWARE DATE (B)(6) 2018 AND DID NOT FIND ANY SIMILAR COMPLAINTS DURING THE SEARCHED PERIOD. THE G8 OPERATOR'S MANUAL UNDER CHAPTER 1, INTRODUCTION AND APPLICATIONS, STATES THE FOLLOWING: THE TIME FROM INJECTION OF THE SAMPLE TO THE TIME THE SPECIFIC PEAK ELUTES OFF THE COLUMN IS CALLED RETENTION TIME. THE TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723G8 SOFTWARE HAS BEEN WRITTEN SO THAT EACH OF THE EXPECTED FRACTIONS HAS A WINDOW OF ACCEPTABLE RETENTION TIMES. IF THE DESIGNATED PEAK FALLS WITHIN THE EXPECTED WINDOW, THE CHROMATOGRAM PEAKS WILL BE PROPERLY IDENTIFIED. WHEN A PEAK ELUTES AT A RETENTION TIME NOT WITHIN A SPECIFIED WINDOW, AN UNKNOWN PEAK (P00) RESULTS. IF MORE THAN ONE PEAK ELUTES AT TIMES NOT SPECIFIED BY THE SOFTWARE WINDOWS, EACH IS GIVEN A SEQUENTIAL P0X TITLE. IN ORDER TO KEEP THE PEAKS WITHIN THEIR APPROPRIATE WINDOWS, IT MAY BE NECESSARY TO CHANGE HOW FAST OR SLOW THE BUFFERS ARE MOVING THROUGH THE SYSTEM BY CHANGING THE PUMP FLOW RATE. THE G8 VARIANT ANALYSIS MODE TRAINING MANUAL UNDER LESSON 8 - TROUBLESHOOTING, STATES THE FOLLOWING: ADJUSTING THE FLOW RATE - HOW AND WHY ON THE TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723G8; VARIANT ANALYSIS MODE IT MAY BE NECESSARY TO ADJUST THE FLOW RATE BECAUSE EITHER UNIDENTIFIABLE PEAKS APPEAR ON ALL THE CHROMATOGRAMS OR THE AVERAGE RETENTION TIME FOR VARIOUS PEAKS HAS CHANGED SIGNIFICANTLY. THE FLOW RATE IS CHANGED BY CHANGING THE FLOW FACTOR IN THE INSTRUMENT. THE FLOW FACTOR IS GENERALLY 1.00 ML/MIN. THE FLOW FACTOR SHOULD ONLY BE ADJUSTED +/- 0.05 OF THE DEFAULT FACTORY SETTING. THE MOST PROBABLE CAUSE OF THE PEAK PATTERN ERROR 211 WAS THE OVER ADJUSTMENT OF THE FLOW RATE TOO HIGH WHEN THE PEAK PATTERN ERROR OCCURRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY WERE GETTING ERROR 211 PEAK PATTERN WHILE RUNNING THE G8 INSTRUMENT. THE CUSTOMER CHANGED THE COLUMN, FILTER, AND THE SAMPLE NEEDLE, BUT THE ERROR PERSISTED. THE PUMP PRESSURE WAS 9.8 AND THE BUFFERS AND WASH WERE AT LEAST HALF FULL. THE CUSTOMER FURTHER REPORTED THAT WHILE WATCHING SAMPLES RUN, THEY NOTICED THE R4 VALVE FLUCTUATING. THE FLUCTUATION STOPS WHEN THE ANALYZER GOES TO PUMP THE WASH. THE CUSTOMER HAD NOT BEEN ABLE TO GET ANY RESULTS DESPITE CHANGING THE COLUMN. FIELD SERVICE ENGINEERING WAS DISPATCHED TO ADDRESS THE REPORTED, WHICH RESULTED IN DELAY OF REPORTING HGA1C PATIENT RESULTS. THERE IS 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
    374591 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1