BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7704626 · Received July 19, 2018

    Report

    Report Number
    8031673-2018-00632
    Event Type
    Malfunction
    Date Received
    July 19, 2018
    Date of Event
    June 21, 2018
    Report Date
    July 19, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. DEVICE EVALUATION BY MANUFACTURER: A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S FACILITY TO ADDRESS THE REPORTED EVENT. FSE INSPECTED THE INSTRUMENT AND FOUND THE UPTAKE CHECK VALVE WAS LEAKING. FSE REPLACED THE CHECK VALVE AND ADJUSTED THE FLOW RATE TO 1.05 ML/MIN. FSE RAN PRECISION AND VERIFIED THE RT IS WITHIN THE RANGE (ACCEPTABLE RANGE IS 0.57 TO 0.61 MINUTES). FSE SUCCESSFULLY COMPLETED QUALITY CONTROL RUN AND VERIFIED INSTRUMENT OPERATION. NO FURTHER ACTION WAS REQUIRED. INSTRUMENT IS FUNCTIONING AS EXPECTED. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(4). THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE G8 VARIANT ANALYSIS MODE 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 FLUCTUATING SA1C RT WAS DUE TO A FAULTY UPTAKE VALVE.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED FLUCTUATING SA1C RETENTION TIME (RT) ON G8 INSTRUMENT. CUSTOMER STATED FLOW FACTOR (FF) HAS BEEN UP TO 1.27 ML/MIN. CUSTOMER WILL ADJUST THE FF TO REFLECT THE SA1C RT BUT THEN THE SA1C RT WILL CONTINUE TO FLUCTUATE HIGHER OR LOWER. CUSTOMER STATED THE PRESSURE HAS BEEN REPORTING MOSTLY IN THE 7.0'S, COLUMN COUNT = 2300, FILTER COUNT (FC) = 48. 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
    546339 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1