BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723GA ANALYZER G8

    MDR report key: 7308573 · Received March 1, 2018

    Report

    Report Number
    8031673-2018-01153
    Event Type
    Malfunction
    Date Received
    March 1, 2018
    Date of Event
    November 1, 2017
    Report Date
    September 14, 2018
    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. ON (B)(6) 2017, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S FACILITY TO ADDRESS THE REPORTED EVENT. THE FSE REPLACED THE BUFFER VALVE #1. THE FSE ALSO ADVISED THE CUSTOMER ON HOW TO REPLACE THE INLET FILTER. THE G8 INSTRUMENT IS OPERATIONAL. NO FURTHER ACTION IS REQUIRED BY FIELD SERVICE. A 13-MONTH COMPLAINT / SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(4) FROM AWARE DATE OF (B)(6) 2017, WHICH INCLUDED DATA FROM 01-OCTOBER-2016 THROUGH 01-NOVEMBER-2017. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD, WHICH INCLUDES THIS EVENT. THE G8 OPERATOR'S MANUAL UNDER SECTION 5.4 ELUTION BUFFER PRIMING IS AS FOLLOWS: 5.4 ELUTION BUFFER PRIMING THE ANALYZER AUTOMATICALLY PERFORMS PRIMING OR PURGING WITH ELUTION BUFFER NO. 1 AND 2 WHEN THE POWER IS TURNED ON AND WHEN IT HAS BEEN IN STAND-BY STATE FOR 90 MINUTES OR MORE. IT REPLACES THE BUFFER IN THE FLOW LINES, AND THEN STARTS THE PUMP RUN AND ASSAY. HOWEVER, IF THE ANALYZER HAS BEEN SHUT DOWN FOR A LONG PERIOD OF TIME, AIR MAY HAVE ENTERED INTO THE FLOW LINES OR THE BUFFER CONCENTRATION IN THE FLOW PATH MAY HAVE INCREASED. AS A RESULT, YOU MAY EXPERIENCE PROBLEMS SUCH AS UNSTABLE PUMPING PRESSURE, ABNORMAL CHROMATOGRAMS (UNIDENTIFIED PEAK P00 MAY APPEAR), AND AN ABNORMAL ASSAY VALUE FOR THE CONTROL. IF THIS HAPPENS, PERFORM A MANUAL PRIMING OF THE BUFFERS, AND THEN PERFORM THE DRAIN FLUSH DESCRIBED IN THE NEXT SECTION. MANUAL PUMPING OF ELUTION BUFFER NO. 1 FOR APPROXIMATELY 20 MINUTES SHOULD RESOLVE THE PROBLEM IN MOST CASES. THE MOST PROBABLE CAUSE FOR BUFFER #1 WAS BEING USED MORE THAN THE OTHER BUFFERS WAS THE VALVE#1 BUFFER WAS DEFECTIVE.

    Additional Manufacturer Narrative · 0

    (B)(4), 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. CORRECTION: UPDATED WITH CORRECT AGE OF THE DEVICE.

    Description of Event or Problem · 0

    ON (B)(6) 2017, A CUSTOMER REPORTED THAT VARIANT ELUTION BUFFER HSI #1 WAS BEING USED MORE THAN THE OTHER BUFFERS ON THE G8 INSTRUMENT. THE CUSTOMER RUNS PATIENT SAMPLES ON HBA1C DIABETES ASSAY. ON (B)(6) 2017, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR 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
    150777 TOSOH HLC-723GA ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1