BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7349478 · Received March 19, 2018

    Report

    Report Number
    8031673-2018-02570
    Event Type
    Malfunction
    Date Received
    March 19, 2018
    Date of Event
    June 10, 2016
    Report Date
    March 19, 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-(B)(4). FSE WAS DISPATCHED AND ON (B)(4) 2016 FOUND A BIG HUNK OF DUST THAT ACCUMULATED IN GEAR OF X2 ACTION CAUSING THE ERRORS. CLEANED GEARS OF DUST BUILDUP AND LOADER. RAN SAMPLE LOADER ROTATION MULTIPLE TIMES WITHOUT ERRORS. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS THE DUST BUILDUP IN X2 GEAR.

    Description of Event or Problem · 0

    ON (B)(6) 2016, THE CUSTOMER REPORTED INTERMITTENT X2 ERRORS WITH THEIR HLC-723G8 ANALYZER. 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
    192184 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1