BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER

    MDR report key: 7136014 · Received December 20, 2017

    Report

    Report Number
    8031673-2017-00195
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    November 24, 2017
    Report Date
    August 31, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K131580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10. CORRECTED DATA. IN SECTION G5 THE 510K NUMBER WAS K071132. THE CORRECTED G8 510K NUMBER IS K131580. IN SECTION H3 DEVICE EVALUATED BY CUSTOMER WAS YES. THE CORRECTED IS NO AND THE COMPLAINTS WAS RESOLVED OVER THE PHONE.

    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. H.3. NO CONCLUSION YET AVAILABLE. INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED GETTING LOW TOTAL AREA AND THE PEAKS ARE NOT DETECTED ON THE G8 INSTRUMENT. CUSTOMER ALSO NOTED THAT THE SAMPLE NEEDLE IS BENT AND HAD NO REPLACEMENT AVAILABLE AT THE FACILITY. A NEW SAMPLE NEEDLE WAS ORDERED FOR THE CUSTOMER WITH AN APPROXIMATE ARRIVAL DATE OF (B)(6) 2017, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR HEMOGLOBIN A1C (HBA1C). THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT ON DEVICE EVALUATION. ON (B)(6) 2017, CUSTOMER RECEIVED AND INSTALLED THE NEW SAMPLE NEEDLE INTO THE G8 INSTRUMENT. CUSTOMER RAN CALIBRATION AND QUALITY CONTROLS AND ALL RESULTED WITHIN ACCEPTABLE SPECIFICATION RANGE. THE G8 INSTRUMENT IS OPERATING AS INTENDED. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM 24-OCT-2016 THROUGH 24-NOV-2017. THERE WAS ONE SIMILAR COMPLAINT IDENTIFIED DURING THE SEARCHED PERIOD. THE G8 OPERATOR'S MANUAL UNDER CHAPTER 1, INTRODUCTION AND APPLICATION, UNDER INTERPRETATION OF RESULTS, PROVIDES GUIDANCE ON THE TOTAL AREA AND CHROMATOGRAPHY . PARAGRAPHS THREE TO FIVE STATE " RESULTS WILL NOT BE REPORTED IF THE TOTAL AREA (TA) IS <500 WHICH CAN BE SEEN IN SEVERE ANEMIA. RESULTS WILL NOT BE REPORTED IF THE TA IS >4000 WHICH CAN BE SEEN IN POLYCYTHEMIA. THE OPTIMAL GOAL FOR TOTAL AREA IS BETWEEN 700-3000. HOWEVER A TA IN THE RANGE OF 500-4000 IS ACCEPTABLE AND REPORTABLE FOR WHOLE BLOOD SPECIMENS. THE CHROMATOGRAM MUST BE EXAMINED FOR ANY UNIDENTIFIABLE PEAKS (I.E., P00, P01,) BEFORE THE A0 PEAK. DO NOT REPORT THE RESULT IF THESE PEAKS EXIST. WHEN THERE IS A QUESTION CONCERNING THE CHROMATOGRAPHY, REPEAT THE SAMPLE. IF THE REPEATED SAMPLE ALSO DISPLAYS UNUSUAL CHARACTERISTICS, IT IS APPROPRIATE TO EVALUATE WHETHER THE UNUSUAL RESULT IS DUE TO AN ABNORMAL SAMPLE, A PROCEDURAL ERROR, AN INSTRUMENT MALFUNCTION OR A SAMPLE-HANDLING PROBLEM. THE MOST PROBABLE CAUSE OF THE ISSUE IS DUE TO A BENT SAMPLE NEEDLE.

    Description of Event or Problem · 1

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913250 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1