BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER

    MDR report key: 7136178 · Received December 20, 2017

    Report

    Report Number
    8031673-2017-00194
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    November 24, 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
    NM, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA THE FSE DISPATCHED DATE WAS (B)(6) 2017. THE CORRECTED DATE IS (B)(6) 2017. 510K WAS K071132. THE 510K IS K131580. DEVICE EVALUATED BY CUSTOMER WAS YES. THE CORRECTED IS NO AND THE COMPLAINTS WAS RESOLVED OVER THE PHONE.

    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) FOLLOWED-UP OVER-THE-PHONE WITH THE CUSTOMER TO ADDRESS THE ISSUE. THE CUSTOMER REPORTED THAT THE FACILITY WAS ABLE TO RUN SAMPLES WITHOUT ANY ISSUES OVER THE WEEKEND. THE G8 INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. 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 2, PRE-INSTALLATION, PROVIDES GUIDANCE ON HOW TO RESOLVE THE ISSUE. IT STATES "8. DRAIN VALVE: IF AN AIR BUBBLE ENTERS THE PUMP ENSUING IN LOW PRESSURE ERRORS, OPEN THIS VALVE TO EXPEL THE BUBBLE WITH A DRAIN FLUSH. DO NOT OPEN THIS VALVE DURING AN ASSAY." FURTHER GUIDANCE IS PROVIDED IN CHAPTER 6 - TROUBLESHOOTING FOR ERROR 101 PRESSURE LOW. HERE, IT STATES THAT THE ERROR IS GENERATED WHEN THE PRESSURE WILL NOT RISE BECAUSE THE PUMP IS UNABLE TO RUN DUE TO AIR BUBBLES IN THE PUMP CHECK VALVE. IT ALSO INSTRUCTED THE CUSTOMER TO: "IF THE ELUTION BUFFER IS EMPTY, PLACE A NEW ELUTION BUFFER AND EXECUTE REAGENT CHANGE. NEXT, EXECUTE DRAIN FLUSH. SEE "CHAPTER 5 SECTION 5.5: PUMP AIR REMOVAL". EXECUTE MANUAL PUMPING USING THE PUMP KEY IN THE MAIN SCREEN (SECOND SCREEN), AND OPEN AND CLOSE THE DRAIN VALVE 2 OR 3 TIMES. IF THE PRESSURE RISES WHEN THE DRAIN VALVE IS CLOSED, THE OPERATION IS COMPLETE. IF THE PRESSURE STILL DOES NOT RISE OR STABILIZE, EXECUTE DRAIN FLUSH AGAIN. IN ADDITION, CONFIRM THAT THE DRAIN VALVE IS SECURELY CLOSED." THE MOST PROBABLE CAUSE OF THE ISSUE CANNOT BE DETERMINED SINCE CUSTOMER REPORTED THAT THE ISSUE WAS RESOLVED PRIOR TO THE FOLLOW-UP CALL.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED GETTING ERROR MESSAGE 101 PRESSURE LOW ON THE G8 INSTRUMENT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915670 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1