Tosoh Automated Glycohemoglobin Analyzer HLC-723G8Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 04560189282919), received between Jan 26, 2022 and Sep 24, 2026 — classified as 71 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (57 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876574 ↗
• MalfunctionSep 15, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50765925 ↗
• MalfunctionSep 14, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50765905 ↗
• MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A customer reported College of American Pathologists (CAP) survey proficiency test failure on the HLC-723 G8 analyzer. The customer did not provide any values for the testing results. The Tosoh Quality Assurance (QA) Laboratory passed all CAP proficiency tests. The customer requested service. Field Service was dispatched.There was no indication of any patient intervention or adverse health consequences due to the reported event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50725480 ↗
• MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A customer reported failed GH5-B 2026 College of American Pathologists (CAP) survey proficiency tests on the HLC-723 G8 analyzer. Value GH-09 failed and the remaining four values were high, but within range. The Tosoh Quality Assurance (QA) Laboratory passed all CAP GH5-B 2026 proficiency tests. The customer requested service. Field Service was dispatched.There was no indication of any patient intervention or adverse health consequences due to the reported event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50704489 ↗
• MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50704447 ↗
• MalfunctionJun 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER CALLED STATING PATIENT SAMPLE RESULTS RECEIVED ON THE G8 ANALYZER DIFFERED FROM THE RESULTS RECEIVED FROM A DIFFERENT PLATFORM IN A REFERENCE LAB. THE G8 ANALYZER PROVIDED A RESULT OF 5.8% COMPARED TO 5.4% FROM A REFERENCE LAB. ANOTHER SAMPLE RESULT FROM THE G8 ANALYZER WAS 5.9% COMPARED TO 5.5% FROM THE REFERENCE LAB. THESE WERE THE ONLY TWO SAMPLES QUESTIONED OUT OF 1000 PATIENT SAMPLES RAN PER MONTH. THE CUSTOMER DOES NOT KNOW WHAT PLATFORM THE REFERENCE LAB USES AND REPORTED THAT THEIR CONTROLS ARE RUNNING CLOSE TO THE MEAN WITH NO ISSUES. THE TWO PATIENT SAMPLES IN QUESTION ARE FROM NEW PATIENTS WITH NO HISTORY TO COMPARE WITH. THE LAST PERIODIC MAINTENANCE PERFORMED A FEW MONTHS PRIOR TO THE DISCREPANT RESULTS SHOWED THE ANALYZER TO BE VERY ACCURATE. THE TECHNICAL SUPPORT SPECIALIST (TSS) POINTED OUT THAT USING JUST ONE POINT FOR EACH ANALYZER DOES NOT GIVE A COMPLETE PICTURE. THE SAMPLES SHOULD HAVE BEEN RUN MULTIPLE TIMES IN ORDER TO RECEIVE AN ACCURATE RESULT. THE CUSTOMER AGREED AND DOES NOT BELIEVE THERE IS ANY ISSUE WITH THE ANALYZER. THE CUSTOMER BELIEVES THE ISSUE IS WITH THE PATIENT SAMPLES. NO FURTHER ACTION REQUIRED. THE G8 ANALYZER IS FUNCTIONING AS EXP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25622118 ↗
• MalfunctionMay 15, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED ¿A HIGHER PATIENT RESULT¿ ON THE G8 ANALYZER. THE PATIENT RESULT OF 14.7% WAS REPORTED OUT AND QUESTIONED BY THE PROVIDER. THE LABORATORY SENT THE SAMPLE TO QUEST DIAGNOSTICS FOR COMPARISON AND RECEIVED A RESULT OF 10.8%, WHICH WAS THE EXPECTED VALUE. QUALITY CONTROL (QC) WAS WITHIN RANGE. THE CUSTOMER REQUESTED SERVICE TO CONFIRM THE ANALYZER IS WORKING AS INTENDED. FIELD SERVICE WAS DISPATCHED FOR FURTHER INVESTIGATION. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED DISCREPANT PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25190556 ↗
• MalfunctionMay 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED POTENTIAL DISCREPANT PATIENT RESULTS FOR HBA1C ON THE HLC-723 G8 ANALYZER. THE PATIENT RESULT WAS 8.7% (NON-DIABETIC RANGE 4.0-6.0%), WHICH WAS CONSISTENT WITH THE PAST FEW RESULTS. DUE TO EXPECTING A LOWER RESULT, THE PHYSICIAN QUESTIONED THE PATIENT RESULT. THE PATIENT SAMPLE WAS RETESTED AT A DIFFERENT LAB USING TRINITY PREMIER AFFINITY AND RECEIVED A RESULT OF 6.0%, REFERENCE RANGE IS UNKNOWN. THE CUSTOMER STATED THEY REVIEWED ALL OF THE PATIENT SAMPLE RESULTS FROM THE PAST YEAR AND FOUND NO OTHER RESULTS THAT WERE QUESTIONABLE. THE CUSTOMER ALSO CONFIRMED THERE WERE NO ISSUES WITH QUALITY CONTROL (QC). THE CUSTOMER STATED THEY WILL REDRAW THE PATIENT SAMPLE AND SEND OUT FOR HEMOGLOBIN ELECTROPHORESIS TESTING. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POTENTIAL DISCREPANT PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107365 ↗
• MalfunctionMay 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED DISCREPANT RESULTS FOR HBA1C SAMPLES ON THE HLC-723 G8 ANALYZER AFTER SENDING THE SAMPLES TO REFERENCE LAB (QUEST DIAGNOSTICS) FOR COMPARISON BECAUSE THEY WERE QUESTIONED BY THE DOCTOR. OF THE THREE SAMPLES SENT OUT TO THE REFERENCE LAB, ONE WAS FOUND TO HAVE CLOTTED AFTER RUNNING ON THE TOSOH G8 ANALYZER AND OTHER TWO SAMPLES SENT OUT, ORIGINALLY TESTED 7.3% AND 8.7% ON THE TOSOH G8 ANALYZER, AND THEN 6.8% AND 8.3% AT THE REFERENCE LAB USING THE ROCHE COBAS ANALYZER; WHICH USES TURBIDIMETRIC INHIBITION IMMUNOASSAY TO TEST FOR HBA1C COMPARED TO HIGH PRESSURE LIQUID CHROMATOGRAPHY (HPLC) TESTING USED BY TOSOH. THE CUSTOMER'S EXPECTED RESULTS WERE MORE CONSISTENT WITH THE ONES RECEIVED BY THE ROCHE COBAS ANALYZER. THE CUSTOMER CONFIRMED QUALITY CONTROL (QC) WAS IN RANGE. THERE WAS NO PATIENT HARM OR TREATMENT CHANGE DUE TO THE POTENTIAL DISCREPANT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072323 ↗
• MalfunctionApr 27, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED ¿HIGH DISCREPANT SA1C PATIENT RESULT¿ ON THE G8 ANALYZER. THE PATIENT RESULT WAS HIGHER THAN EXPECTED AND THE PHYSICIAN SENT OUT THE RESULT TO A REFERENCE LABORATORY AND RESULT WAS SIGNIFICANTLY HIGHER. NO VALUES OR DATA WERE PROVIDED BY THE CUSTOMER AND QUALITY CONTROL (QC) WERE WITHIN RANGES. THE CUSTOMER WILL CALIBRATE AND RERUN QC. THE CUSTOMER CALLED BACK AND STATED THEY RECALIBRATED AND RAN THE CALIBRATOR AS UNKNOWN SAMPLES TO PREVENT THE RESULTS FROM TRANSFERRING TO THEIR LIS. HOWEVER, THE CALIBRATOR VALUES WERE HIGHER AND NOT CONSISTENT WITH THE CALIBRATOR BOTTLE VALUES. THE TSS INSTRUCTED THE CUSTOMER TO MAKE NEW CALIBRATORS AND RERUN QC. THE CUSTOMER FOLLOWED UP WITH TSS AND STATED ALL REAGENTS WERE CHANGED, CALIBRATIONS AND QC WERE RAN, AND ALL WERE WITHIN ACCEPTABLE RANGES. THE G8 ANALYZER IS FUNCTIONING AS EXPECTED AND THE CUSTOMER IS NOT REQUESTING FURTHER SERVICES. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED DISCREPANT PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009828 ↗
• MalfunctionFeb 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED FAILED COLLEGE OF AMERICAN PATHOLOGISTS (CAP) SURVEY CAP GH5-C 2025 FOR HEMOGLOBIN A1C ON THE HLC-723 G8 ANALYZER. THE TOSOH QUALITY ASSURANCE (QA) LABORATORY PASSED ALL CAP GH5-C 2025 PROFICIENCY TESTS. QUALITY CONTROL (QC) AND RETENTION TIME ARE ALL IN ACCEPTABLE RANGE. THE CUSTOMER RERAN THE SAMPLES WITH ALL RESULTS IN RANGE AND ACCEPTABLE. A TECHNICAL SUPPORT SPECIALIST (TSS) EXPLAINED TO THE CUSTOMER THAT POSSIBLE CONTAMINATION MAY HAVE OCCURRED DURING TESTING. THE CUSTOMER SATISFIED WITH THE ANSWER AT THE TIME, BUT LATER CALLED BACK REQUESTING SERVICE TO ENSURE NOTHING IS WRONG WITH THE ANALYZER. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24464626 ↗
• MalfunctionJan 12, 2026Device Emits Odor; Complete Loss of Power

  A CUSTOMER REPORTED THE G8 ANALYZER WAS NOT POWERING ON: THE POWER SWITCH IS NOT STAYING IN THE ON POSITION; IT KEEPS GOING TO THE OFF POSITION. THE CUSTOMER ALSO REPORTED A BURNING SMELL COMING FROM THE INSTRUMENT, BUT NO SMOKE WAS NOTED. A TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO PLUG THE INSTRUMENT INTO THE MAIN OUTLET, BUT THE ISSUE PERSISTS. THE INSTRUMENT AND UPS WERE LEFT UNPLUGGED. THE ANALYZER IS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR FURTHER INVESTIGATION. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24048936 ↗
• MalfunctionDec 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED ¿DISCREPANT PATIENT RESULTS FOR HBA1C WITH CHECK PEAK (FLAG 24)¿ DURING PATIENT RUN ON THE G8 ANALYZER. THE CUSTOMER STATED THE RESULTS WERE REPORTED TO THE PHYSICIAN AND NO PATIENT TREATMENT WAS AFFECTED. THE INITIAL PATIENT RESULT WAS 7.6% WITH FLAG 24 (CHECK PEAKS). THE CUSTOMER REPLACED THE COLUMN PRIOR TO THE RUN AND DID NOT PRIME. THE TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO REPLACE THE FILTER AND PRIME WITH SAMPLES. AFTER PRIMING, THE SAMPLES FLAGGED ON THE LOW END RETENTION TIME (RT) 0.57 MINUTES (RT RANGE 0.57-0.61 MINUTES, HOWEVER THE IDEAL RT IS .59 MINUTES). THE TSS ALSO INSTRUCTED THE CUSTOMER TO LOWER THE FLOW FACTOR FROM 1.04 TO 1.01, WHICH RAISED THE RT TO 0.59 MINUTES. THE CUSTOMER RERAN THE SAMPLE AND RESULT WAS 6.0%, WHICH WAS WITHIN THE PHYSICIAN¿S EXPECTED RANGE (NON-DIABETIC RANGE 4.0-6.0%). THE COLUMN COUNT IS 152 (MAX RECOMMENDED INJECTION IS 2500) AND FILTER COUNT IS 394 (MAX RECOMMENDED VALUE IS 400). NO FURTHER ACTION REQUIRED BY TECHNICAL SUPPORT. THE G8 ANALYZER IS FUNCTIONING AS EXPECTED. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED DISCREPANT PATIENT RESU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864191 ↗
• MalfunctionDec 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED THEIR MANUFACTURED SURVEY SAMPLES WERE NOT PRODUCING AN ACCURATE RESULT ON THE HLC-723 G8 ANALYZER. ONE SAMPLE WITH A KNOWN VALUE OF AROUND 5.0% WAS GIVING A RESULT OF 5.8% WHEN RUN. THE CUSTOMER USED 5UL OF THE SURVEY MATERIAL WITH 750UL OF HEMOLYSIS WASH. THE INITIAL RESULT RECEIVED WAS 5.0%. PER CUSTOMER PROCEDURE, THE SAMPLE MUST BE RERUN TO ENSURE ACCURACY. ADDITIONAL RESULTS ON THE SAME SAMPLE WERE ALL 5.8%. THE RETENTION TIME WAS 0.59 MINUTES AND THE TOTAL AREA SEEMED NORMAL AROUND 1300-1600. THE CUSTOMER REPLACED THE FILTER AND COLUMN, CONFIRMED THAT THE PRESSURE WAS NORMAL, ALL CONNECTIONS WERE SECURE, NO REAGENTS WERE EXPIRED, QUALITY CONTROL (QC) WAS NORMAL, AND THE SURVEY SAMPLE WAS PROPERLY MADE. THE SAMPLES WERE SENT TO A REFERENCE LAB AND THE RESULTS RECEIVED WERE 4.9% AND 5.0%. FIELD SERVICE WAS DISPATCHED. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23812124 ↗
• MalfunctionDec 2, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  A CUSTOMER REPORTED POTENTIAL DISCREPANT PATIENT RESULTS FOR HBA1C WITH CHECK PEAK FLAG ON THE CHROMATOGRAM ON THE HLC-723 G8 ANALYZER. THE RESULTS WERE REPORTED OUT TO THE PATIENT PHYSICIAN. THE INITIAL PATIENT RESULT WAS 7.3%. AFTER RERUNNING THE PATIENT SAMPLE, THE CUSTOMER RECEIVED AN EXPECTED RESULT OF 5.7% (NON-DIABETIC RANGE 4.0-6.0%). THE COLUMN COUNT IS 1292 (MAX RECOMMENDED 2500) AND RETENTION TIME (RT) IS .57 MINUTES (RT RANGE .57-.61 MINUTES, HOWEVER THE IDEAL RT IS .59 MINUTES). TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO ADJUST THE FLOW FACTOR FROM 1.08 TO 1.04. THE CUSTOMER WILL CALIBRATE THE ANALYZER. THERE WAS NO PATIENT HARM OR TREATMENT CHANGE DUE TO THE POTENTIAL DISCREPANT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23700339 ↗
• MalfunctionNov 20, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  A CUSTOMER REPORTED POTENTIAL DISCREPANT PATIENT RESULTS FOR HBA1C ON THE HLC-723 G8 ANALYZER. THE CUSTOMER WAS EXPECTING A RESULT TO REFLECT DIABETIC; HOWEVER, THE PATIENT RESULT WAS 4.1% (NON-DIABETIC RANGE 4-7%). AFTER FURTHER REVIEW OF THE CHROMATOGRAM, THE CUSTOMER FOUND THE RESULT ALSO CONTAINED AN INTERFERENCE PEAK. THE CUSTOMER REQUESTED ASSISTANCE FROM TECHNICAL SUPPORT SPECIALIST (TSS) ON ADDRESSING THE DISCREPANT RESULT. TSS INFORMED THE CUSTOMER THERE MAY BE AN UNKNOWN INTERFERENCE AND SUGGESTED A REDRAW OF THE PATIENT SAMPLE FOR A RERUN. THERE WAS NO PATIENT HARM OR TREATMENT CHANGE DUE TO THE POTENTIAL DISCREPANT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23611970 ↗
• MalfunctionOct 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED INCORRECTLY REPORTED PATIENT RESULTS FOR HBA1C ON THE HLC-723 G8 ANALYZER. THE CUSTOMER REPORTED OUT A PATIENT RESULT OF 13.2%. THE PHYSICIAN STATED THAT THE CUSTOMER DOES NOT HAVE HIGH GLUCOSE AND THE PAST A1C VALUE WAS MUCH LOWER AND NORMAL. THE SAMPLE WAS RERUN AND A RESULT OF 5.4% WAS RECEIVED, WHICH WAS NORMAL BASED ON PATIENT HISTORY. THE CUSTOMER PERFORMED A PRECISION TEST INVOLVING TEN(10) RUNS OF ONE PATIENT. NINE(9) OUT OF THE TEN RUNS WERE BETWEEN 7.9% - 8.0% AND ONE WAS 13.7%. THE PRECISION WAS REPEATED WITH ANOTHER SAMPLE AND THE SAME PATTERN WAS NOTICED. THE CUSTOMER STATED THAT THIS ISSUE STARTED AFTER PERIODIC MAINTENANCE (PM) WAS PERFORMED. THE CUSTOMER ALSO NOTICED THAT THE ONE HIGH SAMPLE IN THE PRECISION WOULD HAVE THE HIGHEST TOTAL AREA 2100, WHILE THE REST WERE AROUND 1200. THE RETENTION TIME FOR ALL SAMPLES WAS 0.58 MINUTES. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23410167 ↗
• MalfunctionOct 21, 2025Fire; Fire

  A CUSTOMER REPORTED FIRE AT THE POWER CABLE CONNECTION TO THE G8 ANALYZER. THE INCIDENT OCCURRED AFTER THE ANALYZER WAS POWERED ON AND CALIBRATION RUN WAS IN PROGRESS, WHEN FLAMES WERE OBSERVED AT THE POWER CABLE CONNECTION. THE CUSTOMER'S ELECTRICIAN INSPECTED THE POWER OUTLET AND FOUND NO ABNORMALITIES. NO INJURIES WERE REPORTED. THE ANALYZER IS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR FURTHER INVESTIGATION. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347405 ↗
• MalfunctionJun 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED ¿DISCREPANT PATIENT RESULT FOR HBA1C¿ ON THE G8 ANALYZER. THE CUSTOMER STATED THE INITIAL PATIENT SAMPLE WAS 6.8%, WHICH WAS REPORTED OUT AND THE PHYSICIAN QUESTIONED THE RESULT; THE PATIENT IS A KNOWN NON-DIABETIC. THE SAME SAMPLE TUBE WAS RERUN AND RESULTED WITH 5.4% PERCENT, WITHIN THE EXPECTED RANGE FOR THIS PATIENT (4.0%-6.0%). NO IMPACT TO PATIENT CARE DUE TO THE DISCREPANT RESULT. THE CUSTOMER ALSO OBSERVED THAT THE SAMPLE NEEDLE APPEARED TO BE BENT. THE CUSTOMER IS REQUESTING SERVICE TO INSPECT THE G8 ANALYZER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR FURTHER INVESTIGATION. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED DISCREPANT PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294538 ↗
• MalfunctionMay 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED ¿TWO (2) DISCREPANT PATIENT RESULTS FOR HBA1C AND A LEAK AT THE COLUMN HEATER¿ ON THE G8 ANALYZER. THE CUSTOMER STATED THE LEFT SIDE OF THE CONNECTION OF THE HEATER WAS LEAKING. THE RESULTS WERE REPORTED OUT AND NO VALUES OR PATIENT INFORMATION PROVIDED. THE CUSTOMER TIGHTENED THE FITTING AT THE COLUMN HEATER THAT CONNECTS TO THE TUBING AND RESOLVED THE LEAKING ISSUE PRIOR TO CALLING TECHNICAL SUPPORT SPECIALIST (TSS). TSS INSTRUCTED THE CUSTOMER TO CHECK THE PRESSURE AND WERE WITHIN SPECIFICATIONS. THE CUSTOMER REPLACED THE FILTER AND NOTICED CHECK PEAK FLAGS. THE RETENTION TIME (RT) WAS 0.57 MINUTES. THE CUSTOMER MENTIONED THEY RERAN THE TWO PATIENT SAMPLES AFTER THE LEAK WAS FIXED AND WERE WITHIN ACCEPTABLE RANGES. TSS HAD THE CUSTOMER CHANGE THE FLOW FACTOR (FF) FROM 1.08 TO 1.05 AND RT IS READING AT 0.59 MINUTES WITH NO FLAGS RECURRING. THE INVESTIGATION DETERMINED THAT AN INCREASED PUMP SPEED CORRECTED THE RT AND RESOLVED THE COMPLAINT. THE CUSTOMER SUCCESSFULLY PERFORMED CALIBRATION WITH NO REPORTED ISSUES. NO FURTHER ACTION REQUIRED BY TOSOH. THE G8 ANALYZER IS FUNCTIONING AS EXPECTED. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21998308 ↗
• MalfunctionApr 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED ¿A DISCREPANT PATIENT SAMPLE AND HBE SUSPECTED FLAG¿ ON THE G8 ANALYZER. THE PATIENT SAMPLE WAS DRAWN ON (B)(6) 2025 AND THE SAME PATIENT SAMPLE WAS TESTED FOUR TIMES ON THE SAME DAY, PRODUCING FOUR DIFFERENT RESULTS: 11.5%, 5.6%, 5.8%, AND 9.2%, THE EXPECTED RESULT WAS 9.2%. DUE TO THE INCONSISTENCE OF THE RESULT, THE CUSTOMER REDREW THE PATIENT TWO DAYS LATER AND SENT THE SAMPLE TO A REFERENCE LABORATORY FOR TESTING; THE METHODOLOGY AND ANALYZER USED BY THE REFERENCE LABORATORY WERE NOT PROVIDED. THE RESULT FROM THE REFERENCE LABORATORY WAS 9.2%, WHICH IS CONSISTENT WITH THE PATIENT¿S HISTORICAL VALUES. THE SAMPLES ARE NO LONGER AVAILABLE FOR FURTHER INVESTIGATION. THE CUSTOMER SUCCESSFULLY PERFORMED OVER 300 PATIENT SAMPLES WITH NO REPORTED ISSUES. TECHNICAL SUPPORT SPECIALIST (TSS) COULD NOT DETERMINE THE CAUSE OF THE REPORTED EVENT. THE DISCREPANT RESULT AND HBE SUSPECTED FLAG FOR SA1C PATIENT SAMPLE WAS AN ISOLATED EVENT. NO FURTHER ACTION REQUIRED BY TOSOH. THE G8 ANALYZER IS FUNCTIONING AS EXPECTED. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21870350 ↗
• MalfunctionMar 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED ¿DISCREPANT PATIENT RESULTS FOR HBA1C¿ ON THE G8 ANALYZER. THE PATIENT SAMPLE RESULT OF 6.5% WAS REPORTED OUT TO THE PHYSICIAN WHO QUESTIONED THE RESULT AND REQUESTED THE SAMPLE TO BE RERAN. THE PATIENT SAMPLE WAS RERUN AND RESULTED WITH 5.2%, WHICH MATCHED THE PATIENT HISTORY RESULT. THE CUSTOMER ALSO HAD DISCREPANCIES WITH TWO OTHER PATIENT SAMPLES BUT DID NOT PROVIDE ANY FURTHER INFORMATION. THE COLUMN COUNT WAS AROUND 1500, THE ANALYZER HAS BEEN CALIBRATED WEEKLY AND QUALITY CONTROLS (QC) RUNNING CLOSE TO THE MEAN. THE CUSTOMER QUESTIONED THE RETENTION TIME ON THE SAMPLES AND TECHNICAL SUPPORT SPECIALIST (TSS) RECOMMENDED THE CUSTOMER USE THE DISCREPANT PATIENT SAMPLE AND RUN A SMALL PRECISION STUDY TO CHECK CONSISTENCY FOR THE RESULTS. THE CUSTOMER FOLLOWED UP WITH TSS AND STATED THEY PERFORMED THE PRECISION STUDY AND SAMPLE RESULTS ARE GREATER THAN 5% DIFFERENCE AND NOT WITHIN THE 5% ACCEPTABLE CRITERIA FOR THE SITE. THE CUSTOMER ALSO MENTIONED RECEIVING HBE SUSPECTED FLAGS ON ALL THREE PRECISIONS OF 6.5% OF THE SAME SAMPLE AND RETENTION TIME (RT) 0.58 MINUTES WERE WITHIN SPECIFICATIONS. NO PATIENT TREATMENT WAS AFFECTED. A FIELD SERVICE ENGINEER (FSE) WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21613119 ↗
• MalfunctionMar 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED ¿DISCREPANT PATIENT RESULTS FOR HBA1C¿ ON THE G8 ANALYZER. THE PATIENT SAMPLE RESULT OF 7.4% WAS REPORTED OUT TO THE PHYSICIAN WHO QUESTIONED THE RESULT AND REQUESTED THE SAMPLE TO BE RERAN. THE SAMPLE WAS SENT OUT TO QUEST LABORATORY USING ENZYMATIC METHODOLOGY AND RESULTED WITH 6.2%, WHICH IS CONSISTENT WITH PATIENT¿S HISTORY RESULT OF 6.2%. NO PATIENT TREATMENT WAS AFFECTED. THE CUSTOMER STATED THE QUALITY CONTROL (QC) WAS WITHIN RANGES, BUT CONCERNED SAMPLE IS RUNNING HIGHER THAN USUAL. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO FURTHER INVESTIGATE THE REPORTED EVENT. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21554863 ↗
• MalfunctionFeb 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED ¿DISCREPANT HBE SUSPECTED¿ FLAG FOR MULTIPLE SAMPLES ON THE G8 ANALYZER. THE ISSUE OCCURRED ABOUT A WEEK AGO, AND THE PATIENT¿S SAMPLE RESULTS WERE REPORTED OUT TO THE PHYSICIAN, WHO QUESTIONED THE REPORTED FINDINGS AND REQUESTED A RERUN. THE CUSTOMER STATED THE ISSUES WERE RESOLVED BY REPLACING THE COLUMN AND BUFFERS. TOSOH WAS NOT INFORMED OF COMPLAINT AT OCCURRENCE, AND RESOLVED ISSUE PRIOR TO REPORTING TO TOSOH. NO OTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER REPORTED THE COMPLAINT FOR DOCUMENTATION PURPOSES, NO TROUBLESHOOTING REQUIRED AT THIS TIME. NO FURTHER FOLLOW UP OR ACTIONS REQUIRED FROM TOSOH. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446862 ↗