BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7486286 · Received May 4, 2018

    Report

    Report Number
    8031673-2018-00406
    Event Type
    Malfunction
    Date Received
    May 4, 2018
    Date of Event
    April 16, 2018
    Report Date
    September 19, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K131580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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 (B)(4) 2018, FIELD SERVICE ENGINEERING (FSE) VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. FSE WAS ABLE TO CONFIRM THE COMPLAINT DUE TO HIGH FLOW RATE AND RETENTION TIME. DURING EVALUATION, FSE FOUND A BAD UPTAKE CHECK VALVE # 021218 AND REPLACED IT. THEY RAN 15 PATIENT SAMPLES AND CONTROLS WITHOUT ANY ERRORS. PATIENT SAMPLES WERE USED TO VALIDATE THE ANALYZER. 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 FOR SERIAL NUMBER (B)(4) FROM (B)(4) 2017 THROUGH AWARE DATE (B)(4) 2018. THERE WERE NO SIMILAR COMPLAINTS FOUND. 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 UNSTABLE RETENTION TIME WAS A BAD UPTAKE CHECK VALVE.

    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: THE CHECK VALVE WAS RETURNED FOR INVESTIGATION ON 05/16/2018. FUNCTIONAL TESTING WITH THE RETURNED PART WAS PERFORMED BUT COULD NOT CONFIRM AN UNSTABLE RETENTION TIME. THE FLOW RATE WAS REPORTED TO BE AROUND 1.11 ML/MIN WITH A RETENTION TIME BETWEEN 0.59 MINUTES AND 0.61 MINUTES. THE CHECK VALVE PERFORMED AS INTENDED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE CHECK VALVE PERFORMED AS INTENDED.

    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.

    Description of Event or Problem · 0

    ON (B)(6) 2018, A CUSTOMER REPORTED THAT THEY WERE NOT GETTING ANY VALUES WITH THE PATIENT RESULTS WHILE RUNNING THE G8 INSTRUMENT. TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO CHECK THE CHROMATOGRAMS WHICH SHOWED DASHED LINES. THE CUSTOMER CHECKED THE REAGENTS, CHANGED THE FILTER, AND CHECK FOR LEAKS BUT NO LEAKS WERE FOUND. TSS THEN REQUESTED THAT THE CUSTOMER SEND CHROMATOGRAMS FOR REVIEW. REVIEW OF THE CHROMATOGRAMS REVEALED 2 WITH AN SA1C RETENTION TIME (RT) OF 0.52 AND SUSPECTED HEMOGLOBIN VARIANT E (HBE) FLAGS, AND 2 HAD SA1C RTS OF 0.61 AND 0.64 (ACCEPTABLE RANGE IS 0.57 TO 0.61 MINUTES). THE FLOW FACTOR WAS SET AT 1.38. THE CUSTOMER STATED THAT WHEN THEY RAN THE SAMPLES WITH THE HBE SUSPECTED FLAGS, THE RT WAS HIGHER WITH NO FLAG. THE CUSTOMER INCREASED THE FLOW FACTOR THE WEEK BEFORE DUE TO HIGH RT. TSS INSTRUCTED THE CUSTOMER TO INCREASE THE FLOW FACTOR TO 1.41 BUT THE SA1C WAS STILL 0.61 AND 0.62. 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
    330520 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1