BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7551609 · Received May 29, 2018

    Report

    Report Number
    8031673-2018-00499
    Event Type
    Malfunction
    Date Received
    May 29, 2018
    Date of Event
    May 15, 2018
    Report Date
    May 29, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. FIELD SERVICE ENGINEERING CONDUCTED A SERVICE CALL WITH THE CUSTOMER OVER-THE-PHONE TO ADDRESS TO ADDRESS THE REPORTED EVENT. FSE WAS ABLE TO CONFIRM THE ERROR. FSE THEN EXPLAINED TO CUSTOMER THAT THE Z1 AXIS MOTORS ARE MOSTLY CAUSED BY A DRY SHAFT AN SCREW DRIVE ON THE Z1 AXIS. FSE ADVISED THE CUSTOMER TO POWER DOWN THE ANALYZER, REMOVE NEEDLE, AND CLEAN SHAFT AND SCREW DRIVE WITH ALCOHOL THEN APPLY LUBRICATION. THE CUSTOMER CLEANED AND APPLIED LUBRICANT TO THE Z1 AXIS AND THE INSTRUMENT WAS RUNNING WITHOUT ANY FURTHER 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 15-APR-2017 THROUGH AWARE DATE 15-MAY-2018. THERE WAS ONE (1) SIMILAR COMPLAINT IDENTIFIED DURING THE SEARCHED PERIOD. THE G8 VARIANT ANALYSIS MODE OPERATOR'S MANUAL UNDER CHAPTER 6, TROUBLESHOOTING, STATES THE FOLLOWING: 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. 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 DUE TO THE DRY Z-AXIS SHAFT AND SCREW DRIVE.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED GETTING INTERMITTENT 710 Z1-AXIS AND LOW TOTAL AREA ERROR MESSAGES ON THE G8 INSTRUMENT. THE CUSTOMER REPORTED THAT THE TOTAL AREA WAS 40.75 AND WHEN THEY REPEATED THE SAMPLE, THE RESULTS AND TOTAL AREA WERE ACCEPTABLE. THE CUSTOMER RAN A SMP RESET SUCCESSFULLY. THE SAMPLE NEEDLE DID NOT APPEAR TO BE BENT AS IT WAS PREVIOUSLY REPLACED. THE INSTRUMENT WAS DOWN. THE A 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
    392617 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1