TOSOH HLC-723G8 ANALYZER G8

Report

Report Number: 8031673-2018-00779
Event Type: Malfunction
Date Received: August 17, 2018
Date of Event: August 3, 2018
Report Date: August 17, 2018
Manufacturer: TOSOH CORPORATION
Product Code: LCP
PMA / PMN Number: K131580
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

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: FIELD SERVICE ENGINEERING (FSE) VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING SERVICING, FSE INSPECTED THE LARGE AND SMALL SYRINGE FOR SECURITY, DAMAGE, AND BUBBLES. HOWEVER, THERE WAS NO DAMAGE OR BUBBLE IN THE SYRINGES. FSE THEN INSPECTED ALL TUBING ON THE INJECTOR LOW PRESSURE SIDE AND FOUND NO EVIDENCE OF LEAKAGE OR DAMAGE. FSE ALSO INSPECTED THE PUMP, LINE FILTER, AND INJECTOR TUBING FOR DAMAGE OR LEAKAGE BUT NONE WERE FOUND. FSE THEN REPLACED THE NEEDLE, SAMPLE LOOP, 5 ML SYRINGE, AND I6 TUBING. FSE ALSO REBUILT THE INJECTOR. FSE RAN THE SAMPLER RESET AND PRIMES SEVERAL TIMES AND FOUND NO LEAKS. THE CUSTOMER MADE QUALITY CONTROLS (QC) AND RAN PATIENT SAMPLES WITH GOOD RESULTS. THE INSTRUMENT WAS OPERATING AS EXPECTED AND RETURNED TO SERVICE. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL (B)(4) FROM 03-JUL-2017 THROUGH AWARE DATE (B)(6) 2018. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE G8 VARIANT ANALYSIS MODE OPERATOR'S MANUAL UNDER CHAPTER 1, INTRODUCTION AND APPLICATIONS, STATES THE FOLLOWING: 1.1 SUMMARY AND EXPLANATION OF TESTS. THE ANALYZER DILUTES THE WHOLE BLOOD SPECIMEN WITH HEMOLYSIS & WASH SOLUTION, AND THEN INJECTS A SMALL VOLUME OF THIS SPECIMEN ONTO THE TSKGEL G8 VARIANT HSI COLUMN. SEPARATION IS ACHIEVED BY UTILIZING DIFFERENCES IN IONIC INTERACTIONS BETWEEN THE CATION EXCHANGE GROUP ON THE COLUMN RESIN SURFACE AND THE HEMOGLOBIN COMPONENTS. THE HEMOGLOBIN FRACTIONS (DESIGNATED AS A1A, A1B, F, LA1C+, SA1C, A0, AND H-V0, H-V1, HV2) ARE SUBSEQUENTLY REMOVED FROM THE COLUMN BY PERFORMING A STEP-WISE ELUTION USING THE VARIED SALT CONCENTRATIONS IN THE VARIANT ELUTION BUFFERS HSI 1, 2, AND 3. 1.8 LIMITATIONS OF THE PROCEDURE. TOTAL AREA: DILUTION STUDIES DEMONSTRATE THAT THE ASSAY IS LINEAR FROM A TOTAL AREA OF 500 TO 4000. HOWEVER, THE OPTIMUM TOTAL AREA IS 700 TO 3000. INTERPRETATION OF RESULTS. RESULTS WILL NOT BE REPORTED IF THE TOTAL AREA (TA) IS <500 WHICH CAN BE SEEN IN SEVERE ANEMIA. RESULTS WILL NOT BE REPORTED IF THE TA IS >4000 WHICH CAN BE SEEN IN POLYCYTHEMIA. (SEE "ABNORMAL RED CELL SURVIVAL IN PREVIOUS SECTION). THE OPTIMAL GOAL FOR TOTAL AREA IS BETWEEN 700-3000. HOWEVER A TA IN THE RANGE OF 500-4000 IS ACCEPTABLE AND REPORTABLE FOR WHOLE BLOOD SPECIMENS. CHAPTER 3 ASSAY OPERATIONS STATES THE FOLLOWING: CHROMATOGRAM. SEE THE G8 VARIANT ANALYSIS MODE TRAINING MANUAL FOR MANY EXAMPLES OF DIFFERENT CHROMATOGRAMS. THE A1A, A1B AND HBF MAY BE ELUTED OUT WITH DIFFERENT PEAK SHAPES OR NOT BE DETECTABLE DEPENDING UPON THE SAMPLE. IF YOU OBSERVE SHOULDERS OR SPLITS AROUND THE SA1C OR A0 PEAK, THE ASSAY CONDITION MAY NOT BE OPTIMAL. IN ADDITION, IF THE SAMPLE HAS BEEN STORED FOR A LONG TIME AT ROOM TEMPERATURE AFTER COLLECTION, AN ABNORMAL CHROMATOGRAM MAY BE OBTAINED BECAUSE THE SAMPLES HAVE DETERIORATED. IF YOU OBSERVE THE SAME PHENOMENA WITH SEVERAL DIFFERENT SAMPLES, THE REAGENT MAY HAVE DETERIORATED. REPLACE THE ELUTION BUFFERS AND RUN THE ASSAY AGAIN. IF YOU OBSERVE AN ABERRANT RESULT WITH A SINGLE SPECIFIC SAMPLE, THE SAMPLE MAY HAVE DETERIORATED OR HEMOGLOBIN VARIANTS MAY BE PRESENT. THE TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723G8 VARIANT ANALYSIS MODE CAN SEPARATE THE MAJOR VARIANT HEMOGLOBINS (HBD, HBS AND HBC). SEE "CHAPTER 6 SECTION 6.4: ABNORMAL CHROMATOGRAMS" FOR TYPICAL CHROMATOGRAMS. BUT SOME HEMOGLOBIN VARIANTS SUCH AS HBE CAN NOT BE SEPARATED AND IT MAY INTERFERE WITH THE ASSAY. THE CHROMATOGRAM PATTERN FOR HEMOGLOBIN VARIANTS DIFFERS FROM THAT OF A NORMAL SAMPLE. CHAPTER 6 TROUBLESHOOTING STATES: 200 AREA LOW ERROR: THREE SUCCESSIVE RESULTS BELOW THE LOWER LIMIT OF THE TOTAL AREA (50) OCCUR. IF THE ERROR MESSAGE IS PRESENT WHEN SUFFICIENT VOLUME OF SAMPLE IS SET IN THE RACK, THE PROBLEM MAY BE CAUSED BY AN EMPTY REAGENT (HEMOLYSIS & WASH SOLUTION). CHECK THE REMAINING VOLUME OF HEMOLYSIS AND WASH SOLUTION AND START THE ASSAY AGAIN. 221 #### NOT DETECT (#### IS THE PEAK ID): A SPECIFIC PEAK (HEMOGLOBIN FRACTION) COULD NOT BE DETECTED. WHEN THIS OCCURS REPEATEDLY WITH SOME SAMPLES, THE ELUTION BUFFER MAY HAVE BECOME CONCENTRATED, RESULTING IN UNIDENTIFIED PEAK DETECTION ON CHROMATOGRAMS. NEVER MIX THE BUFFERS. WHEN THE ERROR ONLY OCCURS WITH SPECIFIC SAMPLES, A HEMOGLOBIN VARIANT MAY BE PRESENT. SECTION 6.4 ABNORMAL CHROMATOGRAMS: ALTHOUGH THE PERCENTAGE OF EACH HEMOGLOBIN COMPONENT MAY VARY SLIGHTLY FROM PATIENT TO PATIENT, MOST WHOLE BLOOD SAMPLES WILL CONTAIN SIX FRACTIONS: A1A, A1B, F, LA1C+, SA1C, AND A0. CHROMATOGRAMS FROM PATIENTS WITH HEMOGLOBIN VARIANTS OR UNKNOWN PEAKS NOT RECOGNIZED BY THE ANALYZER ARE OCCASIONALLY SEEN DURING ROUTINE TESTING. THESE PATTERNS MAY INDICATE INTERFERENCES OR PROBLEMS WITH THE ASSAY. THEREFORE, IT IS IMPORTANT TO USE CAUTION WHEN TROUBLESHOOTING. REVIEW ALL CHROMATOGRAMS TO DETERMINE WHETHER THE RESULTS ARE VALID. IN MOST CASES, RESULTS FOR THE SA1C% ARE REPORTABLE. IN SOME CASES, THE SA1C% MAY BE INVALID DEPENDING ON THE HEMOGLOBINOPATHY PRESENT, THE FLOW RATE, AND THE CONDITION OF THE COLUMN AND REAGENT SYSTEM. MATHEMATICAL ALGORITHMS USED IN THE SOFTWARE EXCLUDE VARIANT PEAKS ELUTING AFTER THE A0 PEAK WHEN CALCULATING THE TOTAL AREA. THE SA1C% IS USUALLY NOT AFFECTED IN SUCH SITUATIONS, ALTHOUGH CHROMATOGRAMS SHOULD BE CAREFULLY REVIEWED. HBS, HBD AND HBC ELUTE AFTER THE A0 PEAK. THE SA1C% IS GENERALLY REPORTABLE ON THE G8 WHEN THESE HEMOGLOBINS ARE PRESENT IN THE HETEROZYGOUS STATE WITH HBA. THE TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723G8 HAS KNOWN HEMOGLOBIN E (HBE) INTERFERENCE. WHEN A SAMPLE IS SUSPECTED TO CONTAIN HBE A FLAG WILL BE DISPLAYED. THE HBA1C RESULT WILL NOT BE REPORTED FROM THE ANALYZER. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FAILURE OF THE LARGE SYRINGE AND A WORN INJECTOR STATOR.

Description of Event or Problem · 0

A CUSTOMER REPORTED HBE SUSPECTED A1A, A1B, AND SA1C FLAGS AND ERROR MESSAGE 221 #### NOT DETECT ON LEVEL 1 AND LEVEL 2 QUALITY CONTROLS (QC) ON THE G8 INSTRUMENT. THE CUSTOMER REPORTED THAT THEY RE-RAN THE CONTROLS THREE TIMES AND THE QC LEVELS WERE IN RANGE. THE CUSTOMER SENT TECHNICAL SUPPORT (TS) CHROMATOGRAMS TO REVIEW AND CONFIRMED THAT THE PATIENT RESULTS WERE NORMAL WITH SA1C RETENTION TIMES (RT) OF 0.60 MINUTES, 0.61 MINUTES, AND 0.62 MINUTES. THE CUSTOMER REPORTED THAT THEY HAVE USED THE CONTROL MATERIAL FOR 5 DAYS BUT THE ISSUE STARTED JUST THE DAY PRIOR. UPON FOLLOW-UP, THE CUSTOMER REPORTED THAT THEY FAILED CALIBRATION WITH A1A AND A1B FLAGS, 221 #### NOT DETECT, AND LOW AREA ERRORS. THE CUSTOMER THEN REPEATED CALIBRATION AND IT PASSED WITHOUT ANY FLAGS. THE QC WAS IN RANGE AND THE PATIENT CHROMATOGRAMS WERE NORMAL. THE CUSTOMER REPORTED THAT THE ISSUES SEEMED TO OCCUR ON THE FIRST RUN. 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
636276	TOSOH HLC-723G8 ANALYZER G8	G8	LCP	TOSOH CORPORATION	G8

Patients

Seq	Age	Sex	Outcome	Treatment
1