BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7366735 · Received March 23, 2018

    Report

    Report Number
    8031673-2018-03660
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Date of Event
    April 8, 2016
    Report Date
    March 23, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. TS (TECHNICAL SUPPORT) CALLED THE CUSTOMER TO TELL THEM THAT THEY ARE USING DI HLC-723RP DRIVER BUT SINCE THEY BEGAN USING THIS DRIVER THE RESULTS ARE TRANSMITTING CORRECTLY TO DI (DATA INNOVATIONS) EXCEPT WHEN IT IS A FLAGGED RESULT. IF A FLAG IS PRESENT ON THE RESULT THE RESULT DOES NOT SHOW IN DI. THEY WILL INFORM THE DEVELOPER OF THE DRIVER SO HE CAN BETTER UNDERSTAND HOW TO MAKE A CHANGE TO THE DRIVER THAT WILL RECTIFY THE PROBLEM. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DI HLC-723RP DRIVER NOT TRANSMITTING FLAGGED RESULTS.

    Description of Event or Problem · 0

    ON (B)(6) 2016 THE CUSTOMER REPORTED INTERFACE NO LONGER WORKING WITH THEIR HLC-723G8 ANALYZER. THE CUSTOMER IS UNABLE TO RUN HBA1C PATIENT SAMPLES. 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
    208721 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1