BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 8136569 · Received December 6, 2018

    Report

    Report Number
    8031673-2018-05309
    Event Type
    Malfunction
    Date Received
    December 6, 2018
    Date of Event
    November 16, 2018
    Report Date
    February 5, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K131580
    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. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. H.3. DEVICE EVALUATION BY MANUFACTURER: THE PIA BOARD WAS RECEIVED FOR EVALUATION. THE PART ARRIVED WITHOUT WIRES AND THEREFORE HAD TO BE SOLDERED ON THE PART. FUNCTIONAL TESTING WAS PERFORMED ON THE PART AND FOUND THAT THE LED ON ASM BOARD CORRESPONDING TO THE PIA BOARD INTERMITTENTLY SHOWED "ON" WHEN NO FLAG WAS TRIPPING THE SENSOR. THE PART FAILED TESTING. THE REPORTED PROBLEM WAS CONFIRMED. H6 EVALUATION CODES: METHODS: 4109-HISTORICAL DATA ANALYSIS, 10-TESTING OF ACTUAL/SUSPECTED DEVICE, RESULTS: 4203-ELECTRICAL/ELECTRONIC COMPONENT IDENTIFIED, CONCLUSION CODE: 4307-CAUSE TRACED TO COMPONENT FAILURE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FAULTY DIODE IN THE PIA BOARD.

    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 (FSE) VISITED THE CUSTOMER TO ADDRESS TO ADDRESS THE REPORTED EVENT. FSE WAS ABLE TO CONFIRM ERROR 712 X2 AXIS AND ERROR 999 X2 HOME OVERRUN IN THE ERROR LOG. FSE WAS ALSO ABLE TO REPRODUCE THE ERRORS. FSE REPLACED THE X2 HOME SENSOR TO RESOLVE THE ERROR. FSE THEN RAN QUALITY CONTROLS (QC) AND 10 PATIENT SAMPLES WITH NO ERRORS AND WITH ACCEPTABLE RESULTS. 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)(6) FROM 16-OCT-2017 THROUGH AWARE DATE (B)(4) 2018. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE G8 VARIANT ANALYSIS MODE OPERATOR'S MANUAL UNDER CHAPTER 6, TROUBLESHOOTING, STATES THE FOLLOWING: 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. 712 X2-AXIS ERROR: CAUSE: INDICATES THAT AN OPERATION ERROR HAS OCCURRED IN THE X2-AXIS. ACTION: INSPECT THE X2-AXIS AND EXECUTE THE SL.ROTATE. THE MOST PROBABLE CAUSE OF THE X2-AXIS ERROR HAS NOT BEEN DETERMINED. THE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED GETTING 712 X2-AXIS ERROR MESSAGES ON THE G8 INSTRUMENT. THE CUSTOMER REPORTED THAT THE WHITE PUSHER FOOT POPS OUT AND ATTEMPTS TO RETURN TO THE HOME POSITION THEN GIVES AN ERROR MESSAGE. 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
    976196 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1