BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER

    MDR report key: 6834862 · Received August 31, 2017

    Report

    Report Number
    8031673-2017-00018
    Event Type
    Malfunction
    Date Received
    August 31, 2017
    Date of Event
    August 3, 2017
    Report Date
    October 25, 2018
    Manufacturer
    TOSOH HI-TEC
    Product Code
    LCP
    PMA / PMN Number
    K131580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. 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. ON (B)(6) 2017 A FIELD SERVICE ENGINEER (FSE) INSTRUCTED THE CUSTOMER TO CHECK FOR PINK FLUID IN THE WELL WHEN RUNNING SAMPLES. THE CUSTOMER CONFIRMED PINK FLUID WAS PRESENT IN THE WASH WELL. THE FSE INSTRUCTED THE CUSTOMER TO CONFIRM WHETHER FILTERS ON THE BUFFERS AND WASH WERE CONNECTED; THE CUSTOMER FOUND THE PLASTIC FILTER IN THE WASH BUFFER BOTTLE WAS DISCONNECTED. A 13-MONTH COMPLAINT HISTORY REVIEW FOR SERIAL NUMBER (B)(4) FOUND NO OTHER COMPLAINT DURING THIS TIME PERIOD. THE G8 OPERATOR'S MANUAL UNDER CHAPTER 3, ASSAY OPERATIONS, STATES TO CHECK THE FLOW LINE CONNECTIONS, PARTICULARLY THE FILTER, DURING WARM UP OPERATIONS PRIOR TO STARTING AN ASSAY. THE ROOT CAUSE OF THE REPORTED ISSUE WAS ATTRIBUTED TO A DISCONNECTED FILTER IN THE WASH BUFFER BOTTLE.

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. UNDER THE ABOVE SECTION "USER FACILITY" WAS INCORRECTLY SELECTED. THE ONLY REPORT SOURCE IS "HEALTH PROFESSIONAL".

    Description of Event or Problem · 0

    ON (B)(6) 2017 THE CUSTOMER REPORTED NO PEAKS AND TOTAL AREA IN PATIENT SAMPLES. ON (B)(6) 2017 A FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER OVER-THE-PHONE TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF 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
    615430 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH HI-TEC G8

    Patients

    Seq Age Sex Outcome Treatment
    1