ARCHITECT 3L80-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00380740161521), received between Aug 28, 2020 and Dec 19, 2025 — classified as 31 malfunctions.

The most frequently reported specific device problem is “High Test Results” (16 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED CO2/BICARB GENERATED FROM ARCHITECT WHEN COMPARED TO A VENOUS BLOOD GAS RESULT. THE CUSTOMER PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, A PATIENT THAT WAS REPORTEDLY EXTREMELY LIPEMIC (NO VALUE PROVIDED) HAD A CO2 OF 8.9 MMOL/L (SAMPLE ID: (B)(6)). THE PATIENT'S PHYSICIAN QUESTIONED THE RESULT SINCE IT DIDN'T MATCH THE PATIENT'S CLINICAL PRESENTATION. ANOTHER SAMPLE WAS OBTAINED (SAMPLE ID: (B)(6)) AND GENERATED A RESULT OF 8.8 MMOL/L. 1:2 DILUTION TESTING GENERATED RESUTLS OF < 10.1 AND < 10.1 MMOL/L (CUSTOMER REFERENCE RANGE: 20-29 MMOL/L). A VENOUS BLOOD GAS WAS OBTAINED AND SHOWED A PCO2 OF 38 MMHG (REPORTEDLY NORMAL PER CUSTOMER). IT WAS CONFIRMED THAT THE PATIENT DID NOT RECEIVE ANY TREATMENT RELATED TO THE FALSELY DECREASED CO2 RESULT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848081 ↗
• MalfunctionJul 7, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT CARBON DIOXIDE RESULTS FOR ONE FEMALE PATIENT. THE PATIENT¿S SAMPLES ARE HIGHER BY THE BLOOD GAS ANALYZER (GEM). THE CUSTOMER PROVIDED THE FOLLOWING DATA: ALL SAMPLES ARE FROM THE SAME PATIENT TESTED ON DIFFERENT DAYS: (B)(6) 2025: SID (B)(6) ARCHITECT RESULT = 15. (B)(6) 2025: SID (B)(6) ARCHITECT RESULT = 10. SID (B)(6) GEM RESULT = 33. (B)(6) 2025: SID (B)(6) ARCHITECT RESULT = 7. SID (B)(6) GEM RESULT = 32. (B)(6) 2025: SID (B)(6) ARCHITECT RESULT = 5. (B)(6) 2025: SID (B)(6) ARCHITECT RESULT = <5. SID (B)(6) GEM RESULT = 33. (B)(6) 2025: SID (B)(6) NO RESULTS PROVIDED. SID (B)(6) GEM RESULT = 36. HISTORICAL DATA: (B)(6) 2025: SID (B)(6) ARCHITECT RESULT = 25. (B)(6) 2025: SID (B)(6) ARCHITECT RESULT = 26. SID (B)(6) GEM RESULT = 32. (B)(6) 2025: SID (B)(6) ARCHITECT RESULT = 26. SID (B)(6) GEM RESULT = 32. (B)(6) 2025: SID (B)(6) ARCHITECT RESULT = 24. NORMAL REFERENCE RANGE IS 22-32 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22420267 ↗
• MalfunctionJun 20, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED CARBON DIOXIDE RESULTS PROCESSED ON THE ARCHITECT C16000 PROCESSING MODULE. THE CUSTOMER REPEATED THE SAMPLE AND THE RESULTS ARE HIGHER. THE CUSTOMER PROVIDED THE FOLLOWING DATA FOR ONE PATIENT: INITIAL RESULT = 8.6438 MMOL/L REPEAT RESULT = 24.7098 MMOL/L. NORMAL REFERENCE RANGE IS 22-29 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22299500 ↗
• MalfunctionApr 1, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED CO2 RESULTS GENERATED ON THE ARCHITECT C4000 ANALYZER ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2025 = <10 MEQ/L (SAMPLE VERY LIPEMIC), REPEATED SAMPLE ON (B)(6) 2025 = <10 MEQ/L. (TRIGLYCERIDE = 2728). ON (B)(6) 2025, NEW SAMPLE = 13, ANOTHER INSTRUMENT (GEM) = (B)(6). ON (B)(6) 2025, NEW SAMPLE = 13, ANOTHER INSTRUMENT (GEM) = 22, SENT TO (B)(6) = 23 (NORMAL RANGE: 22-27 MEQ/L) . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21737419 ↗
• MalfunctionFeb 24, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CO2 PATIENT RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR 3 PATIENTS. THE INITIAL PATIENT RESULTS WERE NOT REPORTED OUT. THE SAMPLES WERE SENT OUT TO A REFERENCE LAB AND LOWER RESULTS WERE GENERATED. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), INITIAL RESULT = 48 REFERENCE LAB RESULT = 20, SID (B)(6), INITIAL RESULT = 50 REFERENCE LAB RESULT = 20, SID (B)(6), INITIAL RESULT = 47 REFERENCE LAB RESULT = 19. PATIENT REFERENCE RANGE 22-29 MMOL/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21451978 ↗
• MalfunctionAug 15, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED BICARB/CO2 GENERATED FROM AN ARCHITECT C4000 THAT WAS NORMAL WHEN RAN ON ANOTHER ANALYZER. THE CUSTOMER PROVIDED THE FOLLOWING DATA: PATIENT REFERENCE RANGE (20-29) MEQ/L SAMPLE 1: INITIAL RUN >50, RERAN >50. WHEN REPEATED ON ANOTHER ANALYZER THE RESULT WAS 27 SAMPLE 2: INITIAL: 45, RERUN 45. WHEN REPEATED ON ANOTHER ANALYZER THE RESULT WAS WITHIN NORMAL RANGE (NO VALUE PROVIDED) THE CUSTOMER REPORTED THAT THEY RECALIBRATED THE ASSAY, WHICH RESOLVED THE ISSUE. SAMPLE 1 RESULT AFTER RECALIBRATIONS WAS 27 & SAMPLE 2 RESULT AFTER RECALIBRATIONS WAS 20. PER THE CUSTOMER THE DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19995747 ↗
• MalfunctionFeb 12, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED CARBON DIOXIDE (CO2) RESULT FOR ONE SAMPLE GENERATED ON GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE. THE SAMPLE WAS ORIGINALLY QUESTIONED BY THE PHYSICIAN DUE TO A LOW ION GAP RESULT. THE FOLLOWING DATA WAS PROVIDED: CO2 INITIAL RESULT = 30 MMOL/L, REPEAT = 28 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684905 ↗
• MalfunctionJan 26, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED CARBON DIOXIDE RESULTS GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR MULTIPLE SAMPLES. THE FOLLOWING EXAMPLE RESULTS WERE PROVIDED: (CUSTOMER PROVIDED CO2 NORMAL RANGE = 22 - 30 MEQ/L). INITIAL RESULT WAS 29 MEQ/L ONE WEEK AGO AND TODAY THE RESULTS WERE 15 MEQ/L AND 15 MEQ/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587366 ↗
• MalfunctionSep 28, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED CARBON DIOXIDE RESULTS FOR 3 PATIENTS USING REAGENT LOT 62947UQ10 WHEN COMPARED TO SAME PATIENTS RESULTS USING REAGENT LOT 63532UQ02. THE RESULTS WERE RELEASED BUT WERE WITHIN THE CUSTOMERS PERMITTED BIAS %. THE CUSTOMER PROVIDED THE FOLLOWING DATA: SID (B)(6) BIAS% 1 22.3 21.2 -4.93, 3 22.6 21.2 -6.19, 4 23.3 21.5 -7.73. NORMAL REFERENCE RANGE IS 22-29 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17834989 ↗
• MalfunctionSep 11, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CO2 RESULTS GENERATED ON THE ARCHITECT C4000 ANALYZER ON MULTIPLE PATIENTS ON (B)(6) 2023. THE FOLLOWING RESULTS WERE PROVIDED: SID RESULT / REPEAT (B)(6) = 30.245 / 25.229 MMOL/L (B)(6) = 33.157 / 24.250 MMOL/L (B)(6) = 29.765 / 29.874/ 23.772 / 22.543 MMOL/L (B)(6) = 33.451 / 23.784 MMOL/L (B)(6) = 31.281 / 19.103 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17718503 ↗
• MalfunctionSep 7, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CARBON DIOXIDE RESULTS GENERATED ON THE ARCHITECT C4000 ANALYZER FOR MULTIPLE PATIENTS. THE FOLLOWING DATA WAS PROVIDED (NORMAL RANGE 22-29 MEQ/L): SAMPLE ID (B)(6) INITIAL RESULT = 30.24 MMOL/L, REPEAT = 25.23 MMOL/L SAMPLE ID (B)(6) INITIAL RESULT = 33.15 MMOL/L, REPEAT = 24 MMOL/L SAMPLE ID (B)(6) INITIAL RESULT = 29.87 MMOL/L, REPEAT = 22.54 MMOL/L SAMPLE ID (B)(6) INITIAL RESULT = 33.45 MMOL/L, REPEAT = 24 MMOL/L SAMPLE ID (B)(6) INITIAL RESULT = 31.28 MMOL/L, REPEAT = 19.1 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17701939 ↗
• MalfunctionJul 21, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED CO2 VALUES FOR MULTIPLE PATIENTS ON THE ARCHITECT C4000. THE SAMPLES WERE REPEATED ON OTHER METHODS AND THE RESULTS WERE HIGHER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) RESULT = 20 BIOLIS RESULT = 28 ISTAT RESULT = 25; SID (B)(6) RESULT = 16 BIOLIS RESULT = 29 ISTAT RESULT = 27; SID (B)(6) RESULT = 16 BIOLIS RESULT = 29 ISTAT RESULT = 28; SID (B)(6) RESULT = 21 BIOLIS RESULT = 28 ISTAT RESULT = 25; SID (B)(6) RESULT = 21 BIOLIS RESULT = 30 ISTAT RESULT = 26; SID (B)(6) RESULT = 15 BIOLIS RESULT = 23 ISTAT RESULT = 24; SID (B)(6) RESULT = 21 BIOLIS RESULT = 29 ISTAT RESULT = 27; SID (B)(6) RESULT = 18 BIOLIS RESULT = 27 ISTAT RESULT = 25; SID (B)(6) RESULT = 17 BIOLIS RESULT = 25 ISTAT RESULT = 21; SID (B)(6) RESULT = 18 ISTAT RESULT = 26; SID (B)(6) RESULT = 16 BIOLIS RESULT = 24 ISTAT RESULT = 23; SID (B)(6) RESULT = 18 BIOLIS RESULT = 27; SID (B)(6) RESULT = 20 BIOLIS RESULT = 28 ISTAT RESULT = 23; SID (B)(6) RESULT = 20 BIOLIS RESULT = 30 ISTAT RESULT = 25; SID (B)(6) RESULT = 20 BIOLIS RESULT = 28 ISTAT RESULT = 23. REFERENCE RANGE: ARCHITECT: 22 TO 29 MEQ/L. BIOLIS: 23 TO 34 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375247 ↗
• MalfunctionJun 12, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED CARBON DIOXIDE RESULTS FOR 1 PATIENT PROCESSED ON THE ARCHITECT C4000 PROCESSING MODULE, SERIAL NUMBER (B)(6). THE CUSTOMER REPEATED ON ANOTHER C4000, SERIAL NUMBER (B)(6), AND THE RESULT WAS HIGHER. THE CUSTOMER PROVIDED THE FOLLOWING DATA(ALL RESULTS ARE FROM (B)(6) 2023): SID (B)(6) INITIAL RESULT = 19 REPEAT RESULT = 24 NORMAL REFERENCE RANGE IS 22-29 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107851 ↗
• MalfunctionMay 18, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED CO2 RESULTS GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR MULTIPLE SAMPLES THAT WERE QUESTIONED BY THE PHYSICIAN. ADDITIONALLY, THE CUSTOMER NOTED A SHIFT IN QUALITY CONTROLS. THE FOLLOWING DATA WAS PROVIDED (UNITS OF MEASURE IS MMOL/L): SID 79217 INITIAL CO2 RESULT = 21, REPEAT = 25. SID 79215 INITIAL CO2 RESULT = 20, REPEAT = 24. SID 79177 INITIAL CO2 RESULT = 19, REPEAT = 22. SID 79167 INITIAL CO2 RESULT = 20, REPEAT = 23 . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16954354 ↗
• MalfunctionApr 6, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CO2 RESULTS GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR 3 PATIENTS. THE RESULTS WERE NOT REPORTED OUT. THE CUSTOMER REPEATED THE SAMPLES AFTER AN INSTRUMENT FLUSH AND CALIBRATION OF THE ASSAY AND THE RESULT WAS LOWER. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1 INITIAL RESULT = 30 MMOL/L REPEAT RESULT = 23; PATIENT 2 INITIAL RESULT = 30 MMOL/L REPEAT RESULT = 22; PATIENT 3 INITIAL RESULT = 31 MMOL/L REPEAT RESULT = 26 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16690152 ↗
• MalfunctionMar 21, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CO2 RESULTS GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR MULTIPLE SAMPLES. (NORMAL RANGE: 22-29 MEQ/L). THE CUSTOMER REPORTS THE RESULTS OF PATIENTS BEGIN TO INCREASE IN VALUE DURING THE DAY. RESULTS NEAR 35 OR 36 MEQ/L, AFTER CALIBRATING GENERATE NORMAL RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583887 ↗
• MalfunctionDec 15, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CO2 RESULTS FOR 6 PATIENTS THAT WERE QUESTIONED BY A PHYSICIAN. OF NOTE, THE RESULTS WERE NORMAL AFTER REMOVING THE COEFFICIENT AND THE QCS ALSO SKEWED HIGH. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 22-29 MMOL/L): SID 1 34.3 MMOL/L, REPEAT AFTER REMOVING COEFFICIENT 25.4 MMOL/L. SID 2 35.1 MMOL/L, REPEAT AFTER REMOVING COEFFICIENT 26.0 MMOL/L. SID 3 31.2 MMOL/L, REPEAT AFTER REMOVING COEFFICIENT 23.1 MMOL/L. SID 4 32.5 MMOL/L, REPEAT AFTER REMOVING COEFFICIENT 24.1 MMOL/L. SID 5 32.8 MMOL/L, REPEAT AFTER REMOVING COEFFICIENT 24.3 MMOL/L. SID 6 34.3 MMOL/L, REPEAT AFTER REMOVING COEFFICIENT 25.4 MMOL/L.. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15991308 ↗
• MalfunctionOct 20, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED CO2 RESULTS FOR TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED (PATIENT REFERENCE RANGE: 23 - 31 MMOL/L): SID (B)(6): INITIAL 7.0 MMOL/L, REPEAT 24 MMOL/L. SID (B)(6): INITIAL 9 MMOL/L, REPEAT 27 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15639168 ↗
• MalfunctionAug 5, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED CARBON DIOXIDE (CO2) RESULTS FOR APPROXIMATELY 50 PATIENT SAMPLES WHILE RUNNING ON THE ARCHITECT C8000 PROCESSING MODULE. WHEN THE CUSTOMER CALIBRATED THE CO2 ASSAY, THE QC WAS OUT-OF-RANGE-LOW. THE CUSTOMER RECALIBRATED WITH NEW CALIBRATION VIALS AND OPENED NEW QC. THE CUSTOMER STATED THE CONTROLS WERE ACCEPTABLE AND STARTED RUNNING PATIENT SAMPLES. CUSTOMER BELIEVES ABOUT 50 PATIENTS RESULTS ARE LOWER THAN THE REFERENCE RANGE AND THE PREVIOUS RESULTS WERE IN RANGE. THE CUSTOMER CONFIRMED NO DISCREPANT RESULTS WERE REPORTED TO THE CLINICIAN. THE FOLLOWING ARE EXAMPLES OF PATIENT RESULTS THAT WERE PROVIDED BY THE CUSTOMER: PATIENT EXAMPLES: SID (B)(6): RESULT 21 MEQ/L, PREVIOUS RESULTS 25/28 MEQ/L SID (B)(6): RESULT 21 MEQ/L, PREVIOUS RESULTS 23/26/25 MEQ/L SID (B)(6): RESULT 19 MEQ/L, PREVIOUS RESULT 23 MEQ/L CUSTOMER'S REFERENCE RANGE: 22-29 MEQ/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15179965 ↗
• MalfunctionApr 26, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CARBON DIOXIDE (CO2) RESULTS GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR MULTIPLE SAMPLES THAT WERE QUESTIONED BY THE PHYSICIAN. THERE WERE APPROXIMATELY 5 PATIENTS WITH CO2 RESULTS THAT GENERATED RESULTS >30 MMOL/L (REFERENCE RANGE IS 22 TO 29 MMOL/L). THE FOLLOWING EXAMPLE DATA WAS PROVIDED: PATIENT A: INITIAL RESULT = (B)(6) MMOL/L, REPEAT = (B)(6) MMOL/L. SAMPLES WERE SENT TO A REFERENCE LABORATORY FOR COMPARATIVE TESTING: (B)(6) 2022 SID (B)(6) INITIAL RESULT = (B)(6) MMOL/L, REFERENCE LAB RESULT = (B)(6) MMOL/L. (B)(6) 2022 SID (B)(6) INITIAL RESULT = (B)(6) MMOL/L, REFERENCE LAB RESULT = (B)(6) MMOL/L. (B)(6) 2022 SID (B)(6) INITIAL RESULT = (B)(6) MMOL/L, REFERENCE LAB RESULT = (B)(6) MMOL/L. (B)(6) 2022 SID (B)(6) INITIAL RESULT = (B)(6) MMOL/L, REFERENCE LAB RESULT = (B)(6) MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14213470 ↗
• MalfunctionDec 22, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CARBON DIOXIDE (CO2) RESULTS FOR 2 PATIENTS WHILE RUNNING ON THE ARCHITECT C8000 PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2021 SID (B)(6): INITIAL CO2 RESULT: 30.9 MEQ/L, REPEAT ON ANOTHER ANALYZER: 23.7 MEQ/L. ON (B)(6) 2021 SID (B)(6): INITIAL CO2 RESULT: 31.4 MEQ/L, REPEAT ON ANOTHER ANALYZER: 25.8 MEQ/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13059687 ↗
• MalfunctionNov 15, 2021High Test Results; High Test Results

  THE CUSTOMER QUESTIONED CARBON DIOXIDE RESULTS FOR MULTIPLE PATIENTS. THE CUSTOMER USES THE REFERENCE RANGE 22-29 MMOL/L. THE FOLLOWING INFORMATION WAS PROVIDED: SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12816709 ↗
• MalfunctionAug 17, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CARBON DIOXIDE (CO2) RESULTS FOR 8 PATIENTS WHILE RUNNING ON THE ARCHITECT C4000 ANALYZER. THE CUSTOMER INVESTIGATED FURTHER AFTER DISCOVERING HIGH PATIENT CO2 RESULTS AND DECIDED TO RUN QC TO VERIFY THAT THE CONTROLS WERE STILL IN RANGE EVEN THOUGH THE DAILY QC WAS PERFORMED AND IN RANGE FOR THAT MORNING. THE QC GENERATED VALUES OUT OF RANGE ON ALL THREE LEVELS OF CONTROL. THE CUSTOMER REMOVED THE OLD PACK WITH 18 TESTS LEFT AND LOADED A NEW REAGENT KIT OF THE SAME LOT NUMBER AND CALIBRATED THE KIT ON THE ANALYZER. THE CUSTOMER RAN QC AND IT WAS IN RANGE FOR THE NEW REAGENT KIT. THE SAMPLES WERE THEN REPEATED ON THE SAME ANALYZER WITH THE FOLLOWING DATA PROVIDED (CUSTOMER¿S NORMAL RANGE: 18-30 MMOL/L): SID (B)(6) = INITIAL = 33 MMOL/L, REPEAT = 24 MMOL/L. SID (B)(6) = INITIAL = 39 MMOL/L, REPEAT = 31 MMOL/L. SID (B)(6) = INITIAL = 43 MMOL/L, REPEAT = 30 MMOL/L. SID (B)(6) = INITIAL = 36 MMOL/L, REPEAT = 25 MMOL/L. SID (B)(6) = INITIAL = 39 MMOL/L, REPEAT = 26 MMOL/L. SID (B)(6) = INITIAL = 35 MMOL/L, REPEAT = 24 MMOL/L. SID (B)(6) = INITIAL = 34 MMOL/L, REPEAT = 21 MMOL/L. SID (B)(6) = INITIAL = 41 MMOL/L, REPEAT = 24 MMOL/L. THERE WAS NO IMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12332539 ↗
• MalfunctionJun 7, 2021Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A HIGH ANION GAP FOR A PATIENT WHILE USING THE ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (NORMAL RANGE ANION GAP: 11-16): SODIUM = CURRENT = 133 MMOL/L / PREVIOUS = 143 MMOL/L. POTASSIUM = CURRENT = 4.6 MMOL/L / PREVIOUS = 5.1 MMOL/L. CHLORIDE = CURRENT = 107 MMOL/L / PREVIOUS = 113 MMOL/L. BICARBONATE (CO2) = CURRENT = 17 MMOL/L / PREVIOUS = 23 MMOL/L. ANION GAP = CURRENT = 18 / PREVIOUS = 12. THE ANION GAP IS CALCULATED MEASUREMENT FROM SODIUM, CHLORIDE AND BICARBONATE (CO2). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11952066 ↗
• MalfunctionMay 27, 2021Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A SHIFT DOWN IN CO2 (CARBON DIOXIDE) RESULTS GENERATED ON THE ARCHITECT C4000 INSTRUMENT AFTER CHANGING THE CALIBRATOR LOT WHEN COMPARED TO THE BLOOD GAS CO2 RESULTS. PATIENT 1 ARCHITECT CO2 RESULT WAS 19 MMOL/L, BLOOD GAS RESULT WAS 28.7 MMOL/L, (REFERENCE RANGE 22 MMOL/L TO 29 MMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895206 ↗