BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723GA ANALYZER G8

    MDR report key: 7330099 · Received March 12, 2018

    Report

    Report Number
    8031673-2018-02428
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    August 1, 2016
    Report Date
    March 10, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. ON 01-AUGUST-2016, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S FACILITY TO ADDRESS THE REPORTED EVENT. THE FSE ADVISED THE CUSTOMER TO LOCATE THE OBSTRUCTION WITH THE FLOW RUNNING. THE FSE ADVISED TO CUSTOMER ON HOW TO FLUSH THE PARTICULATE BLOCKAGE OUT OF THE SYSTEM AND TO RE-ESTABLISH NORMAL PRESSURE. ALL ERRORS CLEARED AND THE G8 INSTRUMENT IS OPERATIONAL. NO FURTHER ACTION IS REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE FOR ERROR 100 PRESSURE HIGH AND ERROR 150 GRAD SENSOR WAS A TUBING OBSTRUCTION. THE TUBING WAS FLUSHED OUT.

    Description of Event or Problem · 0

    ON (B)(6) 2016, A CUSTOMER REPORTED ERROR 100 PRESSURE HIGH AND ERROR 150 GRAD SENSOR ON THE G8 INSTRUMENT. THE CUSTOMER STATED THAT THE HIGH PRESSURE OCCURS AND WHEN THE SYSTEM IS REBOOTED, THE ALARM SOUNDS AND A GRAD SENSOR ERROR APPEARS. THE CUSTOMER IS UNABLE TO RUN PATIENT SAMPLES ON HBA1C DIABETES ASSAY. ON (B)(6) 2016, 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
    173730 TOSOH HLC-723GA ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1