BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER

    MDR report key: 7140463 · Received December 21, 2017

    Report

    Report Number
    8031673-2017-00198
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    November 27, 2017
    Report Date
    December 21, 2017
    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. ON (B)(6) 2017 A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S FACILITY. FSE CONFIRMED THE CUSTOMER'S ISSUE OF GETTING THE H-V PEAK FLAG 40 AFTER THE A0 PEAK. FSE OBSERVED SMALL LEAK NEAR THE FILTER HOUSING, THEN CLEANED AND TIGHTEN THE HOUSING, AND REPLACED THE PREFILTER. FSE ALSO NOTICED THE COLUMN HAD 20 INJECTIONS AND WAS ON BACKWARDS. FSE FLIPPED THE COLUMN TO THE CORRECT FLOW ORIENTATION, THEN RAN PRECISION AND PRIMED THE COLUMN. FSE ALSO RAN CALIBRATION AND QUALITY CONTROLS AND THE G8 INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER ACTION WAS REQUIRED. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR (B)(4) FROM (B)(6) 2016 THROUGH (B)(6) 2017. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE G8 OPERATOR'S MANUAL UNDER CHAPTER 4 - SCREEN OPERATIONS, THE PARAMETER FOR FLAG CODE 40 IS "REPORT IF ONE OR MORE OF H-V0, H-V1 AND H-V2 PEAKS WAS DETECTED. TO ENABLE, SET AS "40 = 0". IN ADDITION, IN CHAPTER 5, MAINTENANCE PROCEDURES, SECTION 5.6 PROVIDES STEP-BY-STEP INSTRUCTIONS FOR COLUMN REPLACEMENT. SPECIFICALLY, NUMBER 8 (PAGE 144) STATES FOR THE CUSTOMER TO "CONNECT THE NEW COLUMN TO THE PUMP (INLET) SIDE ONLY, TAKING CARE OF THE FLOW DIRECTION SHOWN BY THE ARROW ON THE LABEL, WHICH SHOULD BE RIGHT TO LEFT, AND LET THE BUFFER FLOW INTO THE COLUMN WHEN BUFFER COMES OUT OF THE OPEN END OF THE COLUMN, PRESS THE "PUMP" KEY TO STOP THE FLOW." THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE WAS DUE TO COLUMN NO PRIMED AND PUT ON INCORRECTLY.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED GETTING FLAG 40 - H-V PEAK AND NO RESULTS ON PATIENT SAMPLES IN THE G8 INSTRUMENT. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919899 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1