BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7385914 · Received March 30, 2018

    Report

    Report Number
    3005529799-2018-03714
    Event Type
    Malfunction
    Date Received
    March 30, 2018
    Date of Event
    October 18, 2016
    Report Date
    March 30, 2018
    Manufacturer
    TOSOH BIOSCIENCE, INC.
    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-(B)(4). FSE WAS DISPATCHED AND ON 19-OCT-2016 FOUND THAT STANDARD MODE DEFAULTED, RELOADED SOFTWARE 5.23 VER., CHANGED STANDARD MODE TO VARIANT MODE. AFTER CALIBRATION AND PRECISION CHECK, THE CUSTOMER RESUMED OPERATIONS. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS A SOFTWARE FAILURE.

    Description of Event or Problem · 0

    ON (B)(6) 2016 THE CUSTOMER REPORTED SOFTWARE ISSUE, ANALYSER IN STANDARD MODE WITH THEIR HLC-723G8 ANALYZER. CUSTOMER REPORTED ANALYZER IN STANDARD MODE, NO PASSWORD, UTILITY, MODE, NO OPTION TO PICK VARIANT. CAN NOT CHANGE THE MODE BACK TO VARIANT SO THE SOFTWARE NEEDS TO BE RE-LOADED. ON (B)(6) 2016 THE CUSTOMER ALSO REPORTS THAT THE CGRAMS ARE NOT PRINTING AS MUCH INFORMATION AS THE MAIN G8. TS ASKED HIM TO SEND GRAM FROM BOTH G8'S. TS CALLED BACK TO VERIFY THAT THIS G8 IS SET TO THE VARIANT MODE NOT THE STD MODE. 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
    228595 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH BIOSCIENCE, INC. G8

    Patients

    Seq Age Sex Outcome Treatment
    1