BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER

    MDR report key: 6959366 · Received October 18, 2017

    Report

    Report Number
    8031673-2017-00056
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Date of Event
    September 18, 2017
    Report Date
    October 25, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K131580
    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. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. EVAL BY MFR: FSE (FIELD SERVICE ENGINEER) WENT ON SITE ON 28-SEPT-2017.

    Additional Manufacturer Narrative · 0

    H.10. ADDITIONAL MANUFACTURER NARRATIVE: TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. G. 3. REPORT SOURCE: UNDER THE ABOVE SECTION "USER FACILITY" WAS INCORRECTLY SELECTED. THE ONLY REPORT SOURCE IS "HEALTH PROFESSIONAL".

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: ON (B)(6) 2017 A FIELD SERVICE ENGINEER (FSE) REPLACED A BENT SAMPLE NEEDLE ASSEMBLY. THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. A 13-MONTH COMPLAINT HISTORY REVIEW FOR SERIAL NUMBER (B)(4) FOUND NO OTHER SIMILAR COMPLAINTS. THE G8 OPERATOR'S MANUAL STATES ERROR MESSAGE 708 X1-AXIS ERROR MESSAGE IS GENERATED WHEN AN OPERATIONAL ERROR OCCURS WITH THE X1-AXIS. THE OPERATOR IS INSTRUCTED TO INSPECT THE X1-AXIS. CHAPTER 5, MAINTENANCE PROCEDURES, INDICATES TO ENSURE TO CHECK THE SAMPLE NEEDLE ASSEMBLY BEFORE STARTING ANALYSIS. SECTION 5.10, SAMPLE NEEDLE REPLACEMENT, INDICATES TO REPLACE THE SAMPLE NEEDLE ASSEMBLY IF IT IS BENT OR BROKEN. THE MOST PROBABLE OF THE CAUSE OF THE BENT SAMPLE NEEDLE ASSEMBLY COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED ON 18-NOV-2017 AND WENT ON SITE ON 28-SEPT-2017

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED GETTING 708 X1-AXIS ERROR MESSAGE; THEREFORE, WAS UNABLE TO RUN PATIENT SAMPLES FOR HBA1C. THE SAMPLE NEEDLE ASSEMBLY WAS NOT CENTERED IN THE SAMPLE TUBES. ON (B)(6) 2017 A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR HBA1C. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737472 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1