BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7366736 · Received March 23, 2018

    Report

    Report Number
    8031673-2018-03661
    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
    KS, 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) ASKED HIM TO SEND WHAT HE PRINTED OUT AND FOUND THAT THEY HAVE CHECKSUM ERROR DC1. THEY HAVE THE DI (DATA INNOVATIONS) LIS (LABORATORY INFORMATION SYSTEM) BUT NO LANTRONICS BOX. THEY HAVE AN EQUINOX WHICH SITS BETWEEN THE TOSOH AND DI. NO WAY TO MAKE ANY ADJUSTMENTS ON EQUINOX. TS ADVISED THE CUSTOMER TO CONTACT THIRD PARTY PROVIDER TO SEE IF THEY CAN TURN OFF FLOW CONTROL. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS FLOW CONTROL SET INCOORECTLY IN 3RD PARTY BOX.

    Description of Event or Problem · 0

    ON (B)(6) 2016 THE CUSTOMER REPORTED CHECK SUM ERRORS, INTERMITTENT COMMUNICATION ON NEWLY INSTALLED HLC-723G8 ANALYZER. CUSTOMER REPORTED THE NEW G8 IS GIVING CHECKSUM ERRORS INTERMITTENTLY AND IS COMMUNICATING WITH LIS (LABORATORY INFORMATION SYSTEM) INTERMITTENTLY. CAN RUN 4 SAMPLES, ALL CROSS, NO ERRORS. CAN RUN 4 MORE AND GET CHECKSUM ERRORS. 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
    208722 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1