BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7297581 · Received February 26, 2018

    Report

    Report Number
    8031673-2018-01411
    Event Type
    Malfunction
    Date Received
    February 26, 2018
    Date of Event
    June 4, 2015
    Report Date
    February 26, 2018
    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

    THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-(B)(4). TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON 4 JUNE 2015. THE FSE REPLACED THE INJECTION VALVE FILTERS, AS THEY LOOKED VERY WORN. FSE ALSO REPLACED THE PUMP FILTERS AND THE TUBING AS IT HAD A SMALL LEAK DUE TO NOT SEALING FROM THE FILTER HOUSING TO THE PREHEATER. FSE ALSO REPLACED THE 6-WAY VALVE AND RAN A RACK OF SAMPLES, CALIBRATORS, AND CONTROLS SUCCESSFULLY. THE G8 WAS WORKING AS INTENDED. NO FURTHER ACTION REQUIRED BY FSE. THE PROBABLE CAUSE OF THE EVENT WAS RELATED TO THE ROTOR SEAL.

    Description of Event or Problem · 0

    ON (B)(6) 2015 A CUSTOMER REPORTED THAT THEY WERE RECEIVING LOW PRESSURE ERRORS WITH THEIR G8 ANALYZER. THE CUSTOMER WAS UNABLE TO RUN SAMPLES AND REQUESTED SERVICE TO ADDRESS THE REPORTED EVENT. CUSTOMER PERFORMED SEVERAL DRAIN FLUSHES AND THE PRESSURE RETURNED TO NORMAL BUT NO RESOLUTION. AT THE TIME OF THE CALL, CUSTOMER WAS RUNNING A RACK AND HER PRESSURE WAS 10.7. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY REPORTING HBA1 FOR PATIENT RESULTS. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE EVENT CONSEQUENCE DUE TO THE DELAY OF REPORTING PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138883 TOSOH HLC-723G8 ANALYZER G8 G8, PRODUCT CODE: LCP LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1