TOSOH HLC-723G8 ANALYZER G8

Additional Manufacturer Narrative

SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW THROUGH AWARE DATE OF EVENT FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4). THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE ST HBA1C AIA-PACK PACKAGE INSERT STATES THE FOLLOWING: QUALITY CONTROL IN ORDER TO MONITOR AND EVALUATE THE PRECISION OF THE ANALYTICAL PERFORMANCE, IT IS RECOMMENDED THAT COMMERCIALLY AVAILABLE CONTROL SAMPLES BE ASSAYED DAILY. THE MINIMUM RECOMMENDATIONS FOR THE FREQUENCY OF RUNNING INTERNAL CONTROL MATERIAL ARE: · AFTER CALIBRATION, THREE LEVELS OF CONTROLS ARE RUN IN ORDER TO ACCEPT THE CALIBRATION CURVE. · THE THREE LEVELS OF CONTROLS ARE ALSO REPEATED AFTER CALIBRATION WHEN CERTAIN SERVICE PROCEDURES ARE PERFORMED (E.G. TEMPERATURE ADJUSTMENT, SAMPLING MECHANISM CHANGES, MAINTENANCE OF THE WASH PROBE OR DETECTOR LAMP ADJUSTMENT OR CHANGE). IF ONE OR MORE CONTROL SAMPLE VALUE(S) IS OUT OF THE ACCEPTABLE RANGE, IT WILL BE NECESSARY TO INVESTIGATE THE VALIDITY OF THE CALIBRATION CURVE AND THE ASSAY RESULTS BEFORE REPORTING PATIENT VALUES. STANDARD LABORATORY PROCEDURES SHOULD BE FOLLOWED IN ACCORDANCE WITH THE REGULATORY AGENCY UNDER WHICH THE LABORATORY OPERATES. LIMITATIONS OF THE PROCEDURE FOR DIAGNOSTIC PURPOSES, THE RESULTS OBTAINED FROM THIS ASSAY SHOULD BE USED IN CONJUNCTION WITH OTHER DATA (E.G., SYMPTOMS, RESULTS OF OTHER TESTS, CLINICAL IMPRESSIONS, THERAPY, ETC.). VARIANT OPERATOR'S MANUAL CHAPTER 1: INTRODUCTION AND APPLICATIONS: THE TIME FROM INJECTION OF THE SAMPLE TO THE TIME THE SPECIFIC PEAK ELUTES OFF THE COLUMN IS CALLED RETENTION TIME. THE TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723G8 SOFTWARE HAS BEEN WRITTEN SO THAT EACH OF THE EXPECTED FRACTIONS HAS A WINDOW OF ACCEPTABLE RETENTION TIMES. IF THE DESIGNATED PEAK FALLS WITHIN THE EXPECTED WINDOW, THE CHROMATOGRAM PEAKS WILL BE PROPERLY IDENTIFIED. WHEN A PEAK ELUTES AT A RETENTION TIME NOT WITHIN A SPECIFIED WINDOW, AN UNKNOWN PEAK (P00) RESULTS. IF MORE THAN ONE PEAK ELUTES AT TIMES NOT SPECIFIED BY THE SOFTWARE WINDOWS, EACH IS GIVEN A SEQUENTIAL P0X TITLE. IN ORDER TO KEEP THE PEAKS WITHIN THEIR APPROPRIATE WINDOWS, IT MAY BE NECESSARY TO CHANGE HOW FAST OR SLOW THE BUFFERS ARE MOVING THROUGH THE SYSTEM BY CHANGING THE PUMP FLOW RATE. INTERPRETATION OF RESULTS THE SA1C MEASURING RANGE IS 4.0 - 16.9%. THE IDEAL RETENTION TIME FOR SA1C IS 0.59 MINUTES. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FLOW RATE NEEDED TO BE ADJUSTED.

Description of Event or Problem

THE CUSTOMER REPORTED HIGH BIAS WITH COLLEGE OF AMERICAN PATHOLOGISTS (CAP) 2019 GH-5C SURVEY ON THEIR ANALYZER. THE CUSTOMER STATED THAT THEY FAILED ONE (1) HEMOGLOBIN A1C (HBA1C) SAMPLE OUT OF FIVE (5); (GH-15 SAMPLE RESULT IS 10.1% [ACCEPTABLE RANGE IS 9.0-10.0]). THE SAMPLE WAS REPEATED AFTER REFRIGERATING FOR SEVERAL WEEKS AND RESULT WAS 10.0% TECHNICAL SUPPORT SPECIALIST (TSS) SUGGESTED THAT THE CUSTOMER ORDER ANOTHER GH-15 SAMPLE, BUT CUSTOMER DECLINED DUE TO NOT HAVING ENOUGH SAMPLES REMAINING. THE CUSTOMER CONFIRMED THE QUALITY CONTROLS WERE WITHIN ACCEPTABLE RANGE, COLUMN COUNT WAS 712 INJECTIONS AND SA1C RETENTION TIME (RT) WAS 6.1ML/MIN (ACCEPTABLE RANGE 0.57-0.62). TSS ADVISED THE CUSTOMER TO ADJUST THE FLOWRATE SINCE THE RT WAS ON THE HIGH END OF ACCEPTABILITY. THE CUSTOMER ADJUSTED THE FLOW RATE, REPOWERED THE ANALYZER, SUCCESSFULLY COMPLETED CALIBRATION AND QC RUNS. SA1CRT IS NOW AT 0.58 - 0.59ML/MIN. THE 2019 GH-5C SURVEY WAS REPEATED, AND THE SA1C RESULT WAS 9.8% FOR THE SPECIMEN WITH RANGE 9.0-10.0%. NO FURTHER ACTION REQUIRED BY TOSOH. THE ANALYZER IS FUNCTIONING AS EXPECTED. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.