BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7366744 · Received March 23, 2018

    Report

    Report Number
    8031673-2018-03662
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Date of Event
    April 29, 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
    TX, 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. ON 03-MAY-2016 TS (TECHNICAL SUPPORT) TALKED TO THE CUSTOMER TO VERIFY G8 RS232 SETTING ON EACH OF THEIR G8'S. THEY TRANSMIT TO A DI (DATA INNOVATIONS) LANTRONICS BOX WHICH IS CONNECTED TO THEIR VISTA. ON 04-MAY-2016 TS FOLLOW UP CALL AND FOUND THAT THE G8 DID WORK PREVIOUSLY BUT NOT NOW. ON 05-MAY-2016 TS RECEIVED A CALL FROM THE CUSTOMER WHO REPORTED THAT IT WAS DISCOVERED THAT THE G8 WHICH WAS NOT TRANSMITTING, WAS TRANSMITTING ALL FRACTIONS BUT THE SA1C. WHEN TS CALLED BACK TO REQUEST THE TRACINGS, THE CUSTOMER REPORTED THAT IT WAS NOW TRANSMITTING AND ISSUE WAS RESOLVED BY CHANGING DI DRIVER SETTINGS. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WERE INCORRECT DRIVER SETTINGS.

    Description of Event or Problem · 0

    ON (B)(6) 2016 THE CUSTOMER REPORTED INTERMITTENT COMMUNICATION WITH THEIR HLC-723G8 ANALYZER. CUSTOMER REPORTED THAT G8 #1 IS SENDING TO THE DI (DATA INNOVATIONS) BUT NOT #2 AND BOTH HAVE THE SAME SETTINGS. 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
    209697 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1