BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER

    MDR report key: 7124042 · Received December 15, 2017

    Report

    Report Number
    8031673-2017-00177
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    November 15, 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
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN BOTH EVENT AND DEVICE EVALUATED BY MFR OF THE INITIAL REPORT, THE FSE DISPATCHED DATE WAS 20-NOV-2017. THE CORRECTED DATE IS 17-NOV-2017. IN 510K NUMBER WAS K071132. THE CORRECTED 510K IS K131580.

    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) FOUND THE PEEK TUBING WAS NOT PUSHED ALL THE WAY THROUGH THE FINGER NUT. FSE PUSHED THE TUBING THROUGH THE FINER NUT AND THE ISSUE WAS RESOLVED. THE FSE THEN PROCEEDED TO RUN QUALITY CONTROLS, WHICH PASSED WITHOUT ANY ISSUES. THE G8 INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS AFTER COMPLETING THE REPAIR. ON (B)(6) 2017 A FIELD SERVICE ENGINEER (FSE) FOUND THE SAMPLE LOOP TO BE POLLUTED AND REPLACED PEEK SAMPLE LOOP COMPONENT. THE FSE THEN PROCEEDED TO RUN PRECISION, CALIBRATION AND QC, AND ALL PASSED WITHOUT ANY ISSUES. THE G8 INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS AFTER COMPLETING THE REPAIR. A 13-MONTH 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 1, INTRODUCTION AND APPLICATIONS, BEGINNING IN SECTION B: CALIBRATION PROCEDURE PROVIDES GUIDANCE ON CALIBRATION, QC, PRECISION, AND STANDARD RANGES. THE MOST PROBABLE CAUSE OF THE ISSUE WAS THE POLLUTED SAMPLE LOOP.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED GETTING OUT OF RANGE ON QUALITY CONTROLS (QC) WITH THE HBA1C ON THE G8. TECHNICAL SUPPORT SPECIALIST (TSS) INFORMED CUSTOMER THAT THE VALUES ARE WITHIN TOSOH TARGET RANGE. ON (B)(6) 2017 CUSTOMER REPORTED THEY WIDEN THE RANGE AND REQUESTED A VISIT FROM FIELD SERVICE ENGINEER (FSE). ON (B)(6) 2017 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.

    Additional Manufacturer Narrative · 1

    PLEASE DISREGARD THE FOLLOWING INFORMATION AS IT WAS INCORRECTLY REPORTED IN THE ORIGINAL SUBMISSION: "ON (B)(6) 2017 A FIELD SERVICE ENGINEER (FSE) FOUND THE PEEK TUBING WAS NOT PUSHED ALL THE WAY THROUGH THE FINGER NUT. FSE PUSHED THE TUBING THROUGH THE FINER NUT AND THE ISSUE WAS RESOLVED. THE FSE THEN PROCEEDED TO RUN QUALITY CONTROLS, WHICH PASSED WITHOUT ANY ISSUES. THE G8 INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS AFTER COMPLETING THE REPAIR. "

    Description of Event or Problem · 1

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902123 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1