BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER

    MDR report key: 7156455 · Received January 2, 2018

    Report

    Report Number
    8031673-2017-00225
    Event Type
    Malfunction
    Date Received
    January 2, 2018
    Date of Event
    December 1, 2017
    Report Date
    June 14, 2019
    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 (B)(6) 2017 A FIELD SERVICE ENGINEER PROCEEDED TO REPLACE THE PRESSURE PUMP IN ORDER TO RESOLVE THE ISSUE. THE FSE RAN CALIBRATION, QUALITY CONTROLS AND PRECISION CHECK ON THE G8 INSTRUMENT; ALL PASSED. THE G8 INSTRUMENT WAS OPERATING WITHIN SPECIFICATIONS AFTER COMPLETING THE REPAIR. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE G8, (B)(4), FROM (B)(6) 2016 THROUGH (B)(6) 2017. THERE WERE THREE (3) SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD, WHICH INCLUDES THIS EVENT. 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 (B)(4) 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. CHAPTER 6, TROUBLESHOOTING, STATES THE FOLLOWING: 101 PRESSURE LOW THE PRESSURE WILL NOT RISE BECAUSE THE PUMP IS UNABLE TO RUN DUE TO AIR BUBBLES IN THE PUMP CHECK VALVE. IF THE ELUTION BUFFER IS EMPTY, PLACE A NEW ELUTION BUFFER AND EXECUTE REAGENT CHANGE. NEXT, EXECUTE DRAIN FLUSH. SEE "CHAPTER 5 SECTION 5.5: PUMP AIR REMOVAL". EXECUTE MANUAL PUMPING USING THE PUMP KEY IN THE MAIN SCREEN (SECOND SCREEN), AND OPEN AND CLOSE THE DRAIN VALVE 2 OR 3 TIMES. IF THE PRESSURE RISES WHEN THE DRAIN VALVE IS CLOSED, THE OPERATION IS COMPLETE. IF THE PRESSURE STILL DOES NOT RISE OR STABILIZE, EXECUTE DRAIN FLUSH AGAIN. IN ADDITION, CONFIRM THAT THE DRAIN VALVE IS SECURELY CLOSED. THE MOST PROBABLE CAUSE OF THE OUT OF RANGE RETENTION TIME WAS DUE TO A DEFECTIVE PUMP PRESSURE.

    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. CORRECTED DATA: SEE SECTIONS: F9.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A TOSOH FIELD SERVICE ENGINEER (FSE) FOUND PRESSURE TOO LOW, WHICH WAS CAUSING OUT OF RANGE RETENTION TIME (ACCEPTABLE RANGE IS 0.57 TO 0.61 MINUTES) WITH THE G8 INSTRUMENT. THE FSE ORDERED A NEW PRESSURE PUMP. IT IS NOT KNOWN WHETHER HEMOGLOBIN A1C RESULTS WERE IMPACTED DUE TO THE OUT OF RANGE RETENTION TIME. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1