TOSOH HLC-723G8 ANALYZER

Additional Manufacturer Narrative

CORRECTED DATA: D4. SERIAL NUMBER/ UNIQUE DEVICE IDENTIFIER- (B)(6) . 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.

Additional Manufacturer Narrative

H.10. ADDITIONAL MANUFACTURER NARRATIVE: 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 SYRINGE WAS RETURNED FOR FURTHER EVALUATION. THE SYRINGE WAS INSTALLED IN A TESTBED AND COULD NOT GET THE SYRINGE TO FAIL. THE RETURNED SAMPLE DID NOT CONFIRM THE REPORTED ERROR AND WAS DISCARDED. THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE IS UNKNOWN.

Additional Manufacturer Narrative

THE COMPLAINT WAS DISPATCHED TO THE FIELD SERVICE ENGINEER (FSE) DEPARTMENT FOR FURTHER INVESTIGATION. THE FSE CONFIRMED AND REPRODUCED THE REPORTED ERROR BY RUNNING A RACK OF SAMPLES AND THE ERROR OCCURRED. FSE CLEANED THE INJECTION VALVE ROTOR, STATOR AND TUBING MANIFOLD. THE FSE THEN REPLACED THE SAMPLE NEEDLE DUE TO IT BEING BENT ALONG WITH THE SMALL SYRINGE. FSE THEN RAN CALIBRATION, QUALITY CONTROL AND 20 PATIENT SAMPLES. THE RUNS WENT TO COMPLETION AND THE RESULTS WERE WITHIN SPECIFICATION AND WITHOUT ANY ERRORS. INSTRUMENT IS PERFORMING AS INTENDED AND WAS RELEASED. NO FURTHER ACTIONS ARE REQUIRED BY THE FSE. A 13 MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(6) FROM THE 10TH OF JULY 2017 THROUGH AWARENESS DATE ON THE 10TH OF AUGUST 2018. THERE WERE TWO (2) SIMILAR COMPLAINTS INCLUDING THIS ONE IDENTIFIED DURING THE SEARCHED PERIOD. THE G8 VARIANT ANALYSIS MODE OPERATOR'S MANUAL UNDER CHAPTER 6 TROUBLESHOOTING, STATES THE FOLLOWING: ERROR: 200 AREA LOW ERROR EXPLANATION: THE PEAK AREA WHICH DOES NOT REACH THE MINIMUM REQUIRED AREA (50) OCCURRED THREE TIMES IN SERIES. COUNTER MEASURE: CHECK THE SAMPLES, BUFFERS, AND HEMOLYSIS AND WASH SOLUTION. 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.

Description of Event or Problem

THE CUSTOMER REPORTED RECEIVING ERROR 200 AREA LOW ERROR ON THEIR G8 INSTRUMENT. THE CUSTOMER REPLACED THE SAMPLE NEEDLE AND THE WASTE IS NOT BLOCKED AND THE WASH AND HEMOLYSIS SOLUTION IS FULL. THE G8 INSTRUMENT IS DOWN AND UNABLE TO RUN PATIENT SAMPLES. THE CUSTOMER REQUESTED SERVICE. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF HEMOGLOBIN A1C (HBA1C) PATIENT RESULTS. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.