BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7602882 · Received June 14, 2018

    Report

    Report Number
    8031673-2018-00551
    Event Type
    Malfunction
    Date Received
    June 14, 2018
    Date of Event
    May 29, 2018
    Report Date
    June 14, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. DEVICE EVALUATION BY MANUFACTURER: A FIELD SERVICE ENGINEER (FSE) VISITED THE ACCOUNT TO ADDRESS THE REPORTED EVENT. THE FSE INSPECTED THE INSTRUMENT AND FOUND A LEAK AT THE SAMPLE LOOP. THE SAMPLE LOOP CONNECTOR WAS LOOSE AND FSE TIGHTENED THE CONNECTION. FSE VERIFIED PRECISION AND QUALITY CONTROLS WERE WITHIN RANGE. THE G8 INSTRUMENT WAS THEN OPERATIONAL IN ACCORDANCE WITH MANUFACTURER'S SPECIFICATIONS. NO FURTHER ACTION WAS REQUIRED BY THE FSE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM 29-APR-2017 THROUGH AWARE DATE 29-MAY-2018. THERE WERE NO SIMILAR COMPLAINT(S) 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. THE 101 PRESSURE LOW: THE PRESSURE WILL NOT RISE BECAUSE THE PUMP IS UNABLE TO RUN DUE TO AIR BUBBLES IN THE PUMP CHECK VALVE. 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 REPORTED EVENT WAS SAMPLE LOOP TUBING NOT TIGHT ON THE INJECTION VALVE.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED GETTING 101 PRESSURE LOW ERROR MESSAGE WITH THE G8 INSTRUMENT. THE CUSTOMER REPORTED THAT THEY TURNED ON THE INSTRUMENT TO PERFORM A DRAIN FLUSH AND NOTICED LEAKING FROM THE I-4 LINE (INJECTION VALVE). TECHNICAL SUPPORT (TS) INSTRUCTED THE CUSTOMER TO TIGHTEN THE CONNECTOR BUT THEY DID NOT HAVE A WRENCH TO DO SO. THE CUSTOMER REPORTED THAT THE TUBING WAS NOT INSERTED COMPLETELY IN THE CONNECTOR. 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
    445761 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1