BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7385987 · Received March 30, 2018

    Report

    Report Number
    8031673-2018-03730
    Event Type
    Malfunction
    Date Received
    March 30, 2018
    Date of Event
    June 13, 2017
    Report Date
    March 30, 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. THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-2017-0007. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. FSE WAS DISPATCHED AND ON 15-JUN-2017 REPLACED 2 WAY SOLENOID VALVE AND COLUMN DET KIT. REPLACED BUFFERS #1 & #3 AND HEM-WASH SOLUTION. CLEANED LUBED SYRINGE MOTORS AND Y-AXIS RAILS. REPLACED BUFFER BAG FILTERS FROM CUSTOMER STOCK. REPLACED PREFILTER COLUMN, RESET COUNTS FOR BOTH. RAN PRECISION WITHOUT ERRORS. RAN CALIBRATION AND QC, PASSED. RAN SEVERAL PATIENT SAMPLES ALL PASSED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS FAILURE OF 2 WAY SOLENOID VALVE AND COLUMN.

    Description of Event or Problem · 0

    ON (B)(6) 2017 THE CUSTOMER REPORTED GETTING P00 PEAKS ON BOTH QC (QUALITY CONTROL) AND PATIENT SAMPLES WITH THEIR HLC-723G8 ANALYZER. CHECKED SYSTEM FOR LEAKS AND NONE FOUND, BLED SYSTEM OF AIR. PROBABLE CHECK VALVE OR PUMP RELATED ISSUE. ON (B)(6) 2017 CUSTOMER CALLED TO ASK ABOUT THE FSE ARRIVAL TIME BECAUSE THE ANALYZER IS NOT WORKING. THE CUSTOMER IS UNABLE TO RUN HBA1C PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING HBA1C PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229798 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1