BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7649465 · Received June 29, 2018

    Report

    Report Number
    8031673-2018-00598
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    June 8, 2018
    Report Date
    September 18, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR SERIAL (B)(6), WHICH CONFIRMED THAT THERE WERE NO NONCONFORMANCES, FAILURES, DISCREPANCIES, OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT. 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.

    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) VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING THE EVALUATION, FSE REPLACED THE UPTAKE CHECK VALVE AND THE STATOR FACE AND SEAL. FSE THEN PRIMED ALL FLUIDS AND RAN A DRAIN FLUSH. FSE RAN SAMPLES AND CONTROLS SEVERAL TIMES. THE COLUMN TEMPERATURE WAS 25.0. THE COLUMN COUNT AS ARRIVED WAS 4959. FSE REPLACED THE COLUMN THEN CALIBRATED AND RAN CONTROLS AND SAMPLES. CALIBRATION ( LOT ZS6002) WITH RESULTS OF 4.4, 4.4, 4.4, 9.0, 8.9. QUALITY CONTROL (QC) LEVEL 1 WAS 5.4 (RANGE 4.8 - 5.9); QC LEVEL 2 WAS 11.6 (RANGE 10.8 - 12.9). DATA INNOVATIONS (DI) LEVEL 1 WAS 5.4 AND DI LEVEL 2 WAS 11.5. PRECISION HAD A MEAN OF 5.670 WITH A STANDARD DEVIATION (SD) OF 0.048. THE COEFFICIENT OF VARIATION (%CV) OF 0.852. THE LIFE COUNT OF 09816. THE G8 INSTRUMENT WAS OPERATIONAL. NO FURTHER ACTION WAS REQUIRED BY THE FSE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM (B)(6) 2017 THROUGH AWARE DATE (B)(6) 2018. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE G8 VARIANT ANALYSIS MODE OPERATOR'S MANUAL UNDER CHAPTER 1, INTRODUCTION AND APPLICATIONS, STATES THE FOLLOWING: 1.8 LIMITATIONS OF THE PROCEDURE TOTAL AREA DILUTION STUDIES DEMONSTRATE THAT THE ASSAY IS LINEAR FROM A TOTAL AREA OF 500 TO 4000. HOWEVER, THE OPTIMUM TOTAL AREA IS 700 TO 3000. INTERPRETATION OF RESULTS WILL NOT BE REPORTED IF THE TOTAL AREA (TA) IS <500 WHICH CAN BE SEEN IN SEVERE ANEMIA. RESULTS WILL NOT BE REPORTED IF THE TA IS >4000 WHICH CAN BE SEEN IN POLYCYTHEMIA. (SEE "ABNORMAL RED CELL SURVIVAL IN PREVIOUS SECTION). THE OPTIMAL GOAL FOR TOTAL AREA IS BETWEEN 700-3000. HOWEVER A TA IN THE RANGE OF 500-4000 IS ACCEPTABLE AND REPORTABLE FOR WHOLE BLOOD SPECIMENS. CHAPTER 6 TROUBLESHOOTING STATES: 200 AREA LOW ERROR THREE SUCCESSIVE RESULTS BELOW THE LOWER LIMIT OF THE TOTAL AREA (50) OCCUR. IF THE ERROR MESSAGE IS PRESENT WHEN SUFFICIENT VOLUME OF SAMPLE IS SET IN THE RACK, THE PROBLEM MAY BE CAUSED BY AN EMPTY REAGENT (HEMOLYSIS & WASH SOLUTION). CHECK THE REMAINING VOLUME OF HEMOLYSIS & WASH SOLUTION AND START THE ASSAY AGAIN. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FAILURE OR FAULT OF THE UPTAKE VALVE.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED GETTING ERROR 200 AREA LOW ERROR ON QUALITY CONTROL (QC) LEVEL 2 WITH THE G8 INSTRUMENT. THEY CUSTOMER MADE SEVERAL HEMOLYSATES AND A FRESH QC BOTTLE BUT ALL HAVE A LOW AREA. QC LEVEL 1 WAS ACCEPTABLE. TO TROUBLESHOOT, THE CUSTOMER RAN A WHOLE BLOOD DILUTION CUP FIVE TIMES AND 4 OUT OF 5 READ LOW TOTAL AREA ERROR. ADDITIONALLY, THE CUSTOMER RECEIVED A LOW TOTAL AREA ON QC DILUTION. 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
    494612 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1