BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7363545 · Received March 22, 2018

    Report

    Report Number
    8031673-2018-03641
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Date of Event
    April 13, 2017
    Report Date
    March 22, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 14-APR-2017 FOUND THAT THERE WAS AN OBSTUCTION AT THE END OF THE WASTE TUBE THEN REMOVED IT AND IT STARTED TO FLOW WITHOUT RESTRICTION AND ALSO NOTICED THAT THE SUCTION TUBE ON BUFFER # 3 WAS BENT, THEN REPLACED IT WITH A NEW ONE. RAN 20 SAMPLES ALL WITH NO ERRORS AND QC (QUALITY CONTROL) THAT PASSED WELL IN LAB RANGE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS A RESTRICTION AT THE END OF THE WASTE TUBE.

    Description of Event or Problem · 0

    ON (B)(6) 2017 THE CUSTOMER REPORTED FLUID LEAK WITH THEIR HLC-723G8 ANALYZER. CUSTOMER REPORTED HEARING A VERY LOUD SOUND AND SAYS THAT NOTHING IS DRAINING TO THE WASTE, FLUID RAN ON THE COUNTER. 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
    205735 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1