BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7742060 · Received August 2, 2018

    Report

    Report Number
    8031673-2018-00729
    Event Type
    Malfunction
    Date Received
    August 2, 2018
    Date of Event
    July 13, 2018
    Report Date
    August 2, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    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: FIELD SERVICE ENGINEERING VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. FSE WAS ABLE TO CONFIRM THE ERROR IN THE ERROR LOG. DURING FURTHER EVALUATION, FSE FOUND THAT THE SAMPLER NEEDED TO BE CLEANED AND LUBRICATED. FSE ALSO CLEANED THE GUIDE RODS AND THE LEAD SCREW AND APPLIED TRI FLOW OIL. FSE THEN TESTED THE SAMPLER UNIT WITH PATIENT SAMPLES WITHOUT ANY ERRORS. THE INSTRUMENT WAS VERIFIED AS OPERATIONAL. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM (B)(6) 2017 THROUGH AWARE DATE (B)(6) 2018. THERE WAS ONE SIMILAR COMPLAINT IDENTIFIED DURING THE SEARCHED PERIOD. THE G8 VARIANT ANALYSIS MODE OPERATOR'S MANUAL UNDER CHAPTER 6, TROUBLESHOOTING, STATES THE FOLLOWING: THE 6.3 ERROR MESSAGES: WHEN CONSULTING WITH TECHNICAL SUPPORT ABOUT A PROBLEM, PLEASE NOTE THE ERROR MESSAGE AND ERROR NUMBER. IN ADDITION, IF YOU FOLLOW THE SUGGESTED SOLUTIONS IN THIS SECTION AND ARE STILL UNABLE TO RESOLVE THE ERROR, OR IF YOU ENCOUNTER AN ERROR MESSAGE THAT IS NOT NOTED, CONTACT TECHNICAL SUPPORT. GENERAL ERROR MESSAGES: WITH THESE ERRORS, THE ASSAY STOPS AND THE ANALYZER IMMEDIATELY ENTERS STAND-BY STATE. THE 710 Z1-AXIS ERROR: AN ABNORMALITY OCCURRED IN THE UP AND DOWN MOVEMENT OF THE SAMPLING NEEDLE. IF THIS OCCURS DURING A STAT ASSAY, CHECK THAT THE CONTAINER SETTING (CUP OR TUBE) IS CORRECTLY SET. THE ERROR ALSO OCCURS WHEN THE SAMPLE VIAL WAS NOT RECOGNIZED AS A PRIMARY TUBE, DUE TO THE DISORIENTED SAMPLE SENSOR. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS THE SAMPLER NEEDED LUBRICATION.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED GETTING 710 Z1-AXIS ERROR MESSAGES ON THE SECOND AND THIRD SAMPLE IN THE RACK WHILE RUNNING THE G8 INSTRUMENT. THE CUSTOMER STATED THAT THE SAMPLE NEEDLE WAS STRAIGHT AND POWERED THE INSTRUMENT OFF AND ON. HOWEVER, THE ERROR PERSISTED. TECHNICAL SUPPORT (TS) INSTRUCTED THE CUSTOMER RUN ONE RACK OF TUBES WITHOUT CAPS AND THE SAMPLE DID NOT GET ANY ERRORS. TS THEN INSTRUCTED THE CUSTOMER TO CHANGE THE NEEDLE, RECALIBRATE AND THEN RUN QUALITY CONTROL (QC). THE CUSTOMER REPORTED THAT THE Z1-AXIS ERROR REOCCURRED. TS INSTRUCTED THE CUSTOMER TO CLEAN THE SAMPLE NEEDLE GUIDE ROD WITH ALCOHOL AND LUBRICATE. THE ERROR PERSISTED. 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 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
    583474 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1