A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW WAS PERFORMED FOR SIMILAR COMPLAINTS FOR SERIAL NUMBER (B)(4). THERE WERE NO SIMILAR COMPLAINTS FOUND DURING THE SEARCHED PERIOD. THE G8 OPERATOR'S MANUAL UNDER CHAPTER 1, INTRODUCTION, STATES THE FOLLOWING: CALIBRATION PROCEDURE: THE ANALYZER HAS A TWO-POINT AUTOMATIC CALIBRATION FUNCTION. EACH LABORATORY MUST MONITOR QC RESULTS ACCORDING TO GOOD LABORATORY PRACTICES TO DETERMINE WHEN TO RECALIBRATE. CALIBRATION FREQUENCY SHOULD BE BASED UPON QC RESULTS AND CHROMATOGRAM QUALITY. CALIBRATION IS STABLE FOR AT LEAST SEVEN DAYS IF THE SYSTEM IS CALIBRATED AND MAINTAINED ACCORDING TO THE PROCEDURES PROVIDED IN THE TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723G8 OPERATOR'S MANUAL. CALIBRATION ACCEPTABILITY CRITERIA WHEN THE CALIBRATION PROCEDURE IS COMPLETED, THE ANALYZER AUTOMATICALLY ACCEPTS OR REJECTS THE CALIBRATION RESULTS. IF THE CALIBRATION IS UNSUCCESSFUL, RECALIBRATION WILL BE REQUIRED. A CALIBRATION ERROR MESSAGE APPEARS AND THE RUN ABORTS IF: THE TWO SA1C% RESULTS FOR CALIBRATOR 1 DIFFER BY 0.3% OR MORE. THE TWO SA1C% RESULTS FOR CALIBRATOR 2 DIFFER BY 0.3% OR MORE. ANY OF THE FOUR CALIBRATOR RESULTS DIFFER FROM ITS ASSIGNED VALUE BY ? 30% OR MORE. SECTION 1.6 OF THE OP'S MANUAL PROVIDES DETAILED INFORMATION ON CALIBRATION PREPARATION AND PROCEDURE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO ANALYZER REQUIRED CALIBRATION AND A FLOW RATE ADJUSTMENT.
D
Patient 1
THE CUSTOMER REPORTED DURING THEIR COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY TESTING SURVEY SAMPLES FOR HEMOGLOBIN A1C (HBA1C), THE SAMPLE RESULTS WERE OUT OF RANGE HIGH ON THEIR G8 ANALYZER. WHEN COMPARED TO THE RESULTS FROM THE CUSTOMER'S OTHER G8 ANALYZER, THE RESULTS WERE IN RANGE BUT RUNNING HIGH. CUSTOMER STATED, CALIBRATION IS ONLY DONE WHEN THE COLUMN IS CHANGED; SA1C RETENTION TIME (RT) IS 0.60, FLOW FACTOR(FF) IS 1.10. TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO INCREASE FLOW FACTOR TO 1.12, POWER OFF AND ON THE ANALYZER AND RUN FIVE SAMPLES AS PRIMES TO CHECK THE RT, CALIBRATE AND RUN CONTROLS, THEN RERUN SURVEY SAMPLES. TSS FOLLOWED UP WITH THE CUSTOMER AND THE CUSTOMER STATED THAT CHANGING THE FLOW FACTOR CHANGED THE SA1C RT TO 0.59 AND CALIBRATION MADE RESULTS THE SAME ON BOTH ANALYZERS. CUSTOMER WILL CALCULATE NEW CONTROL MEAN BASED ON RESULTS FROM THE CURRENT ANALZER AND USE THE SD FROM THE INSERT RANGE. SURVEY SAMPLES ARE TOO OLD TO RERUN. NO FURTHER ACTION REQUIRED. THE G8 ANALYZER IS FUNCTIONING AS EXPECTED. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT SURVEY RESULTS.