BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7291132 · Received February 22, 2018

    Report

    Report Number
    8031673-2018-00093
    Event Type
    Malfunction
    Date Received
    February 22, 2018
    Date of Event
    January 23, 2018
    Report Date
    February 22, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. ON 24-JAN-2018, A FIELD SERVICE ENGINEER (FSE) CONFIRMED BROAD PEAKS ON PATIENT SAMPLES. THE FSE REPLACED ELUTION BUFFER 2 AS THE PROBLEM STARTED AFTER REPLACING IT. ELUTION BUFFERS 1 AND 3 WERE ONLY HALF USED. THE FSE NOTICED BROAD PEAKS PERSISTED. THE FSE PERFORMED TEST ON ELUTION BUFFERS 2-WAY SOLENOID VALVES. THE 2-WAY SOLENOID VALVE FOR ELUTION BUFFER 3 FAILED. THE FSE REPLACED THE 2-WAY SOLENOID VALVE. THE FSE THEN RERAN TEST ON ALL 2-WAY SOLENOID VALVES, WHICH PASSED. THE FSE RAN A PATIENT SAMPLE AND OBTAINED A BROAD PEAK. THE FSE CLEANED AND FLUSHED THE DRAIN LINE; FOUND THE WASTE TUBE GOING TOO FAR DOWN ON THE BOTTOM OF THE WASTE BOTTLE. THE FSE TRIMMED THE WASTE TUBE TO GO INTO THE WASTE BOTTLE AND NOT SIT IN THE WASTE LIQUID. THE FSE THEN REPLACED ELUTION BUFFER 1 AND 2 AND OBTAINED CHROMATOGRAMS WITH GOOD PEAKS. THE FSE THEN PERFORMED CALIBRATION, RAN QUALITY CONTROLS, AND PRECISION, ALL PASSED WITHIN SPECIFICATIONS. NO FURTHER ACTION WAS REQUIRED BY THE FSE. THE G8 INSTRUMENT WAS WORKING WITHIN SPECIFICATIONS. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(4) FROM 23-DEC-2016 THROUGH AWARE DATE (B)(6) 2018. 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: INTERPRETATION OF RESULTS: 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. CHAPTER 2, PRE-INSTALLATION, UNDER SECTION 2.5 CONNECTIONS, STATES: WASTE TUBE: INSERT THE WASTE TUBE FIRMLY INTO THE WASTE PORT LOCATED ON THE BOTTOM OF THE MAIN UNIT. (REFER TO FIG. 2-9). SECURELY TIGHTEN THE WASTE TUBE WITH THE TIE WRAP PROVIDED IN THE ACCESSORY BOX. INSERT THE OTHER END OF THE TUBE INTO THE WASTE BOTTLE. (REFER TO FIG. 2-10) NOTE: IF THE WASTE TUBE IS BENT, THE WASTE LIQUID MAY NOT DRAIN OUT SMOOTHLY. ADJUST (CUT) THE TUBE LENGTH TO KEEP THE TUBE END ABOVE THE WASTE LIQUID LEVEL. WHEN CHANGING THE ANALYZER LOCATION, MAKE SURE THAT THE TUBE IS NOT LOOSE, BROKEN OR BENT AND THAT THE WASTE LIQUID DRAINS UNOBSTRUCTED. THE SAMPLE LOADER MUST ALSO BE TEMPORARILY DISCONNECTED WHEN CHANGING THE ANALYZER LOCATION. PLEASE CONTACT THE AUTHORIZED REPRESENTATIVES. IF THE WASTE TUBE IS BENT AND WASTE LIQUID CANNOT DRAIN, THE SAMPLE DILUTION MAY NOT BE ACCURATELY PERFORMED DURING THE ASSAY. KEEP THE WASTE TUBE END ABOVE THE TOP OF THE WASTE LIQUID. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO THE WASTE TUBE GOING TOO FAR DOWN THE WASTE BOTTLE, CAUSING BLOCKAGE.

    Description of Event or Problem · 0

    ON (B)(6) 2018, A CUSTOMER REPORTED BROAD PEAKS ON PATIENT SAMPLES WITH THE G8 INSTRUMENT. THE CUSTOMER REBOOTED THE INSTRUMENT, BUT THE ISSUE PERSISTED. THE CUSTOMER REQUESTED SERVICE IN ORDER TO ADDRESS THE ISSUE. 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 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
    134009 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1