BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 8144653 · Received December 7, 2018

    Report

    Report Number
    8031673-2018-05299
    Event Type
    Malfunction
    Date Received
    December 7, 2018
    Date of Event
    November 13, 2018
    Report Date
    February 15, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K131580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: 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. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR SERIAL NUMBER (B)(4), WHICH CONFIRMED THAT THERE WERE NO NONCONFORMANCES, FAILURES, DISCREPANCIES, OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT.

    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.DEVICE EVALUATION BY MANUFACTURER: A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER'S SITE TO ADDRESS THE REPORTED EVENT. FSE CONFIRMED CUSTOMER WAS EXPERIENCING INTERMITTENT A1A NOT DETECTED. FSE CHECKED THE FLUIDICS, VALVE OPERATION AND ADJUSTED FLOW FACTOR FOR RT TO 0.58-0.59. FSE RAN PRECISION AND QUALITY CONTROLS. ALL RESULTS WERE WITHIN ACCEPTABLE RANGES. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE G8 INSTRUMENT IS FUNCTIONING AS EXPECTED. THE G8, SERIAL NUMBER (B)(6), WAS INSTALLED ON 01-JAN-2018. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FROM INSTALLATION DATE THROUGH AWARE DATE. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE G8 VARIANT ANALYSIS MODE OPERATOR'S MANUAL UNDER CHAPTER 1 INTRODUCTION AND APPLICATION STATES THE FOLLOWING: THE TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723G8 USES NON-POROUS ION EXCHANGE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) FOR RAPID, ACCURATE AND PRECISE SEPARATION OF THE STABLE FORM OF HBA1C FROM OTHER HEMOGLOBIN FRACTIONS. ANALYSIS IS CARRIED OUT WITHOUT OFF-LINE SPECIMEN PRETREATMENT OR INTERFERENCE FROM SCHIFF BASE. THE ANALYZER DILUTES THE WHOLE BLOOD SPECIMEN WITH HEMOLYSIS & WASH SOLUTION, AND THEN INJECTS A SMALL VOLUME OF THIS SPECIMEN ONTO THE TSKGEL G8 VARIANT HSI COLUMN. SEPARATION IS ACHIEVED BY UTILIZING DIFFERENCES IN IONIC INTERACTIONS BETWEEN THE CATION EXCHANGE GROUP ON THE COLUMN RESIN SURFACE AND THE HEMOGLOBIN COMPONENTS. THE HEMOGLOBIN FRACTIONS (DESIGNATED AS A1A, A1B, F, LA1C+, SA1C, A0, AND H-V0, H-V1, HV2) ARE SUBSEQUENTLY REMOVED FROM THE COLUMN BY PERFORMING A STEP-WISE ELUTION USING THE VARIED SALT CONCENTRATIONS IN THE VARIANT ELUTION BUFFERS HSI 1, 2, AND 3. 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 MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FLOW RATE NEEDED ADJUSTMENT.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED NOT GETTING RESULTS ON SOME SAMPLES ON THE G8 INSTRUMENT. THE CUSTOMER THINKS IT MIGHT BE DUE TO THE RETENTION TIME. TECHNICAL SUPPORT SPECIALIST (TSS) WAS UNABLE TO CONFIRM CUSTOMER'S COMPLAINT BECAUSE CUSTOMER PROVIDED INSUFFICIENT DATA FOR REVIEW. CUSTOMER'S RETENTION TIME (RT) WAS 0.58 (THE ACCEPTABLE RANGE IS 0.57 TO 0.61 MINUTES; OPTIMAL IS 0.59 MINUTE) 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
    982152 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1