BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7337950 · Received March 14, 2018

    Report

    Report Number
    8031673-2018-02512
    Event Type
    Malfunction
    Date Received
    March 14, 2018
    Date of Event
    January 13, 2017
    Report Date
    March 14, 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).TS EXPLAINED WHAT DATA IS SENT AND HOW TO SEND IT. CONFIRMED HER TRANS SETTING IS SET TO 7. HAD THE CUSTOMER REBOOT THE G8, ADVISED TO CONTACT DI (DATA INNOVATIONS) IF FURTHER ISSUES. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS INTERFACE ISSUE WITH DI.

    Description of Event or Problem · 0

    ON (B)(6) 2017, THE CUSTOMER REPORTED INTERFACE ISSUES WITH NEW LIS WITH THEIR HLC-723G8 ANALYZER. CUSTOMER STATED THEY WERE DOWN, HAD SERVICE (FOR LOW TOTAL AREAS) AND NOW INTERFACE IS NOT WORKING, NOT SENDING CORRECT RESULTS. THE CUSTOMER IS UNABLE TO RUN HBA1C PATIENT SAMPLES. TS (TECHNICAL SUPPORT) EXPLAINED WHAT DATA IS SENT AND HOW TO SEND IT. CONFIRMED HER TRANS SETTING IS SET TO 7. HAD THE CUSTOMER REBOOT THE G8, ADVISED TO CONTACT IF FURTHER ISSUES. 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
    182230 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1