Alinity 07P7220Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 00380740121594), received between Apr 11, 2019 and Sep 14, 2026 — classified as 90 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (38 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 90 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Imprecise or Erratic Results

  The customer reported imprecise Alinity c Carbon Dioxide (CO2) results generated across multiple Alinity c Processing Modules. The customer stated that the anion gaps were running low. The following data was provided (Reference range: 22-29 mmol/L):(b)(6) (b)(6): units: mmol/LSID (b)(6): CO2 Initial = 30; Repeat = 28SID (b)(6): CO2 Initial = 30; Repeat = 27SID (b)(6): CO2 Initial = 30; Repeat = 28SID (b)(6): CO2 Initial = 31; Repeat = 29SID (b)(6): CO2 Initial = 22; Repeat = 20.Thelma (b)(6): units: mmol/LSID (b)(6): CO2 Initial = 30; Repeat = 28SID (b)(6): CO2 Initial = 30; Repeat = 28SID (b)(6): CO2 Initial = 31; Repeat = 28SID (b)(6): CO2 Initial = 22; Repeat = 21. There was no impact to patient management reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754752 ↗
• MalfunctionSep 1, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50549791 ↗
• MalfunctionFeb 5, 2026Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED ALINITY C CO2 GENERATED FROM ALINITY C PROCESSING MODULE AND PROVIDED THE FOLLOWING DATA FOR A 34-YEAR-OLD MALE PATIENT ON (B)(6) 2026: CUSTOMER BICARB/CO2 REFERENCE INTERVAL - 22 TO 32 MMOL/L. SAMPLE (B)(6) ALINITY BICARBONATE =12 MMOL/L (B)(6), 13 MMOL/L (B)(6) & 13 MMOL/L (B)(6). RADIOMETER ABL 800= 25.4MMOL/L LIPAEMIC INDEX=2.94 TRIGLYCERIDE= 31.64MMOL/L . FOR SAMPLE (B)(6) (SAME PATIENT DIFFERENT SAMPLE) ALINITY BICARBONATE= 13MMOL/L (B)(6) ABL 800= 26.6 MMOL/L LIPAEMIC INDEX=3.40. PATIENT INFORMATION: ICU ADMITTING DIAGNOSIS OF PYREXIA OF UNKNOWN ORIGIN THE CUSTOMER REPORTED THAT THEY AMENDED THE CO2 RESULTS AND IT WAS REPORTED THAT THERE WAS NO KNOWN ADVERSE IMPACT TO THE PATIENT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269601 ↗
• MalfunctionNov 3, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CO2 RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE ON MULTIPLE PATIENTS. EXAMPLE RESULTS PROVIDED: PT 1 INITIAL RESULT= 31 RERUN OTHER INSTRUMENTS = 25, PT 2 INITIAL RESULT= 36 RERUN OTHER INSTRUMENTS = 26, PT 3 INITIAL RESULT= 31 RERUN OTHER INSTRUMENTS = 24, CUSTOMER NORMAL RANGE (22-28 MEQ/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23449926 ↗
• MalfunctionOct 28, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED ALINITY C CARBON DIOXIDE WAS GENERATED FROM ALINITY C PROCESSING MODULE AND PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, SAMPLE ID (B)(6), INITIAL RESULT WAS 5 MMOL/L. THE PATIENT'S PHYSICIAN QUESTIONED THIS RESULT. THE SAMPLE WAS REPEATED AND THE RESUTLS WERE 22, 23, 23, & 26 MMOL/L. PATIENT INFORMATION: 65-YEAR-OLD FEMALE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23403192 ↗
• MalfunctionOct 22, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY C CARBON DIOXIDE PATIENT RESULTS AND QUALITY CONTROLS (QC) OUT OF RANGE. THE FOLLOWING EXAMPLE DATA WAS PROVIDED (CUSTOMER PROVIDED REFERENCE RANGE: 22 TO 31 MMOL/L): INITIAL RESULT = 33 MMOL/L, REPEAT AFTER RECALIBRATION = 25 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356526 ↗
• MalfunctionOct 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED INCONSISTENT ALINITY C CO2 RESULTS WHEN PROCESSING ON THE ALINITY C PROCESSING MODULE. ON (B)(6) 2025 SAMPLES WERE REPEATED AND RESULTS WERE AMENDED. THE CUSTOMER USES REFERENCE RANGE: 21 ¿ 30 MMOL/L. SID (B)(6) TESTED 35, 24, 29. SID (B)(6) TESTED 31, 19, 24. SID (B)(6) TESTED 32, 20, 26. SID (B)(6) TESTED 31, 18, 24. SID (B)(6) TESTED 37, 24. SID (B)(6) TESTED 39, 24. SID (B)(6) TESTED 35, 24. SID (B)(6) TESTED 39, 22. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23237830 ↗
• MalfunctionOct 6, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY C CARBON DIOXIDE RESULTS WHEN COMPARED WITH BLOOD GAS RESULTS FOR A 79-YEAR-OLD MALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 22 - 32 MMOL/L): SAMPLE ID (B)(6), (B)(6) 2025 INITIAL RESULT = 2.0 MMOL/L, REPEAT RESULT = 2.2 MMOL/L, (B)(6) 2025 REPEAT RESULT = 1.7 MMOL/L. VENOUS BLOOD GAS RESULT ON RADIOMETER PLATFORM = 29.0 MMOL/L (REFERENCE RANGE 22-28 MMOL/L) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23229711 ↗
• MalfunctionSep 17, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED ALINITY C CARBON DIOXIDE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 22 ¿ 32 MMOL/L): (B)(6) 2025, SID (B)(6), INITIAL CO2 RESULT ((B)(6)) = 6.8 MMOL/L; REPEAT RESULT= 6.8 MMOL/L; REPEAT RESULT ((B)(6)) = 4.1 MMOL/L; RADIOMETER CO2 RESULT= 20 MMOL/L (RELEASED RESULT); LIPEMIA INDEX= 1.3; TRIGLYCERIDE= 27 MMOL/L ADDITIONAL RESULTS WERE PROVIDED: QEP (SERUM PROTEIN ELECTROPHORESIS) AND SFLC (SERUM FREE LIGHT CHAIN) WERE NORMAL. ADDITIONAL SAMPLES WERE COLLECTED WITH THE FOLLOWING RESULTS: SID (B)(6), INITIAL CO2 RESULT= 15 MMOL/L; RADIOMETER CO2= 17 MMOL/L, LIPEMIA INDEX= 0.83, TRIGLYCERIDES= 21.9. (B)(6) 2025, SID (B)(6), INITIAL CO2 RESULT= 21 MMOL/L; RADIOMETER CO2 RESULT = 25 MMOL/L; LIPEMIA INDEX= 0.29. (B)(6) 2025, SID (B)(6), INITIAL CO2 RESULT= 21 MMOL/L; RADIOMETER CO2 RESULT = 23 MMOL/L; LIPEMIA INDEX= 0.11; TRIGLYCERIDES= 4.9. (B)(6) 2025, SID (B)(6), INITIAL CO2 RESULT= 23 MMOL/L; RADIOMETER CO2 RESULT = 25 MMOL/L; LIPEMIA INDEX= 0.38; TRIGLYCERIDES= 5.8 THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076319 ↗
• MalfunctionJul 18, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED LOW ANION GAP (< 3) AND UPON FURTHER REVIEW NOTED DECREASED RESULTS FOR ALINITY C CO2 GENERATED FROM ALINITY C PROCESSING MODULE. THE CUSTOMER PROVIDED THE FOLLOWING DATA: SID: (B)(6) CO2 WAS 23 AND REPEAT WAS 22 (SN: (B)(6). REPEAT ON ANOTHER ANALYZER (SN: (B)(6) AND THE RESULT WAS 21. PATIENT¿S RESULT FROM YESTERDAY WAS 24. CUSTOMER REFERENCE RANGE IS FOR CO2 IS 22-31 MMOL/L. CUSTOMER ALSO REPEATED SAMPLE (B)(6) AND CO2 WAS 22 (SN: (B)(6) AND REPEAT RESULT WAS 21 (SN: (B)(6). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22549157 ↗
• MalfunctionJul 14, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C CARBON DIOXIDE FOR ONE PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE CO2 23-29 MMOL/L): ON (B)(6) 2025, NO SID PROVIDED, INITIAL CO2 RESULT= 34 MMOL/L; REPEAT RESULT= 27 MMOL/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22492713 ↗
• MalfunctionJul 2, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED ALINITY C CARBON DIOXIDE GENERATED FROM ALINITY C PROCESSING MODULE (SN: (B)(6) AND PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, SAMPLE ID (B)(6) INITIAL RESULT WAS 6. REPEAT RESULTS WERE 23 AND 22. REPEAT ON ANOTHER ANALYZER (SN: (B)(6) AND THE RESULT WAS 21. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384920 ↗
• MalfunctionJun 24, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY C CARBON DIOXIDE RESULTS FOR ONE PATIENT WITH A HISTORY OF IGG K PARAPROTEIN. THE FOLLOWING DATA WAS PROVIDED: SAMPLE 1 INITIAL RESULT, ON (B)(6) 2025 WITH SERIAL NUMBER (B)(6) AND LOT NUMBER 66642UQ07, WAS 12 MMOL/L SAMPLE 2 INITIAL RESULT, ON (B)(6) 2024 WITH SERIAL NUMBER (B)(6) AND LOT NUMBER 66500UQ06, WAS 12 MMOL/L THE PATIENT¿S PREVIOUS RESULTS WERE PROVIDED: (B)(6) 2025, AT A DIFFERENT SITE, RESULT WAS 14, REPEAT, ON A RADIOMETER ANALYZER, WAS 28.3 MMOL/L; (B)(6) 2024, AT A DIFFERENT SITE, RESULT WAS 17, REPEAT RESULT, ON A RADIOMETER ANALYZER, WAS 25.4 MMOL/L; (B)(6) 2010 RESULT WITH A ROCHE ASSAY WAS 8, REPEAT, ON THE GEM, WAS 27. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322446 ↗
• MalfunctionJun 24, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY C CARBON DIOXIDE RESULTS FOR ONE PATIENT WITH A HISTORY OF IGG K PARAPROTEIN. THE FOLLOWING DATA WAS PROVIDED: SAMPLE 1 INITIAL RESULT, ON (B)(6) 2025 WITH SERIAL NUMBER (B)(6) AND LOT NUMBER 66642UQ07, WAS 12 MMOL/L SAMPLE 2 INITIAL RESULT, ON (B)(6) 2024 WITH SERIAL NUMBER (B)(6) AND LOT NUMBER 66500UQ06, WAS 12 MMOL/L THE PATIENT¿S PREVIOUS RESULTS WERE PROVIDED: (B)(6) 2025, AT A DIFFERENT SITE, RESULT WAS 14, REPEAT, ON A RADIOMETER ANALYZER, WAS 28.3 MMOL/L; (B)(6) 2024, AT A DIFFERENT SITE, RESULT WAS 17, REPEAT RESULT, ON A RADIOMETER ANALYZER, WAS 25.4 MMOL/L; (B)(6) 2010 RESULT WITH A ROCHE ASSAY WAS 8, REPEAT, ON THE GEM, WAS 27. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322403 ↗
• MalfunctionJun 11, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DECREASED ALINITY C CARBON DIOXIDE RESULT FOR ONE PATIENT WITH A HISTORY OF IGG K PARAPROTEIN. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) INITIAL RESULT, ON 13MAY2025 WITH SERIAL NUMBER (B)(6) AND LOT NUMBER 67438UQ12, WAS 14, RESULT USING RADIOMETER BLOOD GAS WAS 28 MMOL/L. SAMPLE ID (B)(6) INITIAL RESULT, ON 20NOV2024 WITH SERIAL NUMBER AC01718 AND LOT NUMBER 66500UQ06, WAS 17, REPEAT, ON RADIOMETER, WAS 25.4 MMOL/L. THE CUSTOMER PERFORMED DILUTION STUDIES WHICH WERE INCONCLUSIVE. THE CUSTOMER PERFORMED PEG STUDIES WHICH SHOWED 167% AND THE CONTROL PATIENT USED HAD 97% RECOVERY. THE SAMPLE WAS ALSO TESTED ON THE GEM AND THE RESULT WAS 27. THE PATIENT¿S PREVIOUS RESULTS WERE PROVIDED: 23JAN2025, AT A DIFFERENT SITE, RESULT WAS 12 MMOL/L; 02NOV2024, AT A DIFFERENT SITE, RESULT WAS 12 MMOL/L; 21JAN2010 RESULT WITH A ROCHE ASSAY WAS 8, REPEAT, ON THE GEM, WAS 27. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22187569 ↗
• MalfunctionJun 6, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DECREASED ALINITY C CARBON DIOXIDE RESULT FOR ONE PATIENT WITH A HISTORY OF IGG K PARAPROTEIN. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2025, WAS 14, RESULT USING RADIOMETER BLOOD GAS WAS 28 MMOL/L. SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2024, WAS 17, REPEAT, ON RADIOMETER, WAS 25.4 MMOL/L. THE CUSTOMER PERFORMED DILUTION STUDIES WHICH WERE INCONCLUSIVE. THE CUSTOMER PERFORMED PEG STUDIES WHICH SHOWED 167% AND THE CONTROL PATIENT USED HAD 97% RECOVERY. THE SAMPLE WAS ALSO TESTED ON THE GEM AND THE RESULT WAS 27. THE PATIENT¿S PREVIOUS RESULTS WERE PROVIDED: (B)(6) 2025, AT A DIFFERENT SITE, RESULT WAS 12 MMOL/L; (B)(6) 2024, AT A DIFFERENT SITE, RESULT WAS 12 MMOL/L; (B)(6) 2010 RESULT WITH A ROCHE ASSAY WAS 8, REPEAT, ON THE GEM, WAS 27. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22162024 ↗
• MalfunctionMay 22, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY C CO2 RESULTS FOR TWO SAMPLES. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) ALINITY C CO2 RESULT 20, COBAS RESULT 22.4, SIEMENS RESULT 22.1 SID (B)(6) ALINITY C CO2 RESULT 21, COBAS RESULT 22.7, SIEMENS RESULT 22.3 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073556 ↗
• MalfunctionMay 5, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED DISCREPANT CARBON DIOXIDE (CO2) RESULTS GENERATED FROM ALINITY C PROCESSING MODULE FOR SEVERAL PATIENTS DURING (B)(6) 2025. THE RESULTS PROVIDED WERE: THE UNIT IS MMOL/L. (B)(6) INITIAL=25.2 /REPEATED=30.0. (B)(6) INITIAL=18.2 /REPEATED=26.3. (B)(6) INITIAL=19.2 /REPEATED=19.3 AND 24.6. (B)(6) INITIAL=19.4 /REPEATED=19.7 AND 27.8. (B)(6) INITIAL=18.4 /REPEATED=22.8. (B)(6) INITIAL=17.4 /REPEATED=22.5. (B)(6) INITIAL=16.2 /REPEATED=17.0 AND 23.5. (B)(6) INITIAL=17.1 /REPEATED=17.5 AND 28.3. (B)(6) INITIAL=19.4 /REPEATED=22.4. (B)(6) INITIAL=19.2 /REPEATED=27.5. (B)(6) INITIAL=16.7 /REPEATED=18.0 AND 24.1. (B)(6) INITIAL=17.1 /REPEATED=22.7. (B)(6) INITIAL=21.6 /REPEATED=30.5. (B)(6) INITIAL=25.4 /REPEATED=30.2. (B)(6) INITIAL=24.7 /REPEATED=30.9. (B)(6) INITIAL=26.4 /REPEATED=31.3. (B)(6) INITIAL=27.6 /REPEATED=29.9. (B)(6) INITIAL=24.3 /REPEATED=30.1. (B)(6) INITIAL=27.0 /REPEATED=32.3. (B)(6) INITIAL=26.6 /REPEATED=33.1. ON (B)(6) 2025 (B)(6) INITIAL=29.7 /REPEATED=25.6. ON (B)(6) 2025 (B)(6) INITIAL=29.7 /REPEATED=24.9. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962595 ↗
• MalfunctionApr 24, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY C CO2 RESULTS. THE FOLLOWING RESULTS WERE PROVIDED (NORMAL CO2 RANGE 18-32 MMOL/L): INSTRUMENT SN: (B)(6). SID (B)(6), (B)(6) 2025, INITIAL RESULT 21 MMOL/L, PREVIOUS RESULT 26 MMOL/L, SID (B)(6), (B)(6) 2025, INITIAL RESULT 23 MMOL/L, PREVIOUS RESULT 46 MMOL/L (ON (B)(6) 2025). INSTRUMENT SN: (B)(6). SID (B)(6), (B)(6) 2025, INITIAL RESULT 20 MMOL/L, PREVIOUS RESULT 26 MMOL/L (ON (B)(6) 2025), SID (B)(6), (B)(6) 2025, INITIAL RESULT 20 MMOL/L, PREVIOUS RESULT 24 MMOL/L (ON (B)(6) 2025). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21902078 ↗
• MalfunctionApr 17, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED CARBON DIOXIDE (CO2) RESULTS GENERATED FROM ALINITY C PROCESSING MODULE FOR A PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6) INITIAL= 8 MMOL/L /REPEATED ON ROCHE=26 MMOL/L /ON ISTAT=30 MMOL/L /REPEATED AND REDRAWN SID (B)(6) INITIAL= 8 MMOL/L /REPEATED ON ROCHE=26 MMOL/L /ON ISTAT=30 MMOL/L LABORATORY REFERENCE RANGE FOR CO2=23 TO 30 MMOL/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857962 ↗
• MalfunctionApr 7, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED ALINITY C CARBON DIOXIDE FOR ONE PATIENT WITH A HISTORY OF PLASMA CELL DYSCRASIA AND IGG LAMBDA AND OLIGOCLONAL IMMUNOGLOBULINS. THE PATIENT HAD HISTORICAL NORMAL CO2 RESULTS STARTING IN 2002. IN 2019, THE PATIENT HAD AN EPP PERFORMED WHICH IDENTIFIED A SMALL DISCREET ABNORMAL BAND. IT WAS ALSO NOTED BEGINNING IN 2019 THAT THE CO2 VALUES WERE LOWER AND BY 2021 THE RESULTS GENERATED WERE <20 MMOL/L. THE PATIENT SAMPLE GENERATED THE LOW RESULTS ON THE ALINITY, BUT WHEN RUN ON A ROCHE ANALYZER AND A BLOOD GAS ANALYZER, THE CO2 RESULTS WERE NORMAL. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024, SID (B)(6), INITIAL CO2 RESULT (BOWEN HILLS FACILITY)= 10 MMOL/L. (B)(6) 2025, SID (B)(6), INITIAL CO2 RESULT (BOWEN HILLS FACILITY)= 6.36 MMOL/L; BLOOD GAS RESULT= 24 MMOL/L (REPORTED). (B)(6) 2025, SID (B)(6), INITIAL CO2 RESULT (LISMORE FACILITY)= 7 MMOL/L. ADDITIONAL INFORMATION WAS PROVIDED ON 17APR2025. THE PATIENT HAD A HISTORY OF DIABETES, ESSENTIAL HYPERTENSION, PRESUMED AUTOIMMUNE HYPOTHYROIDISM, HYPERCHOLESTEROLEMIA, DIVERTICULITIS AND MGUS. THE FOLLOWING HISTORICAL RESULTS WERE PROVIDED: (B)(6) 2019, CO2= 22 MMOL/L; (B)(6) 2020, CO2= 22 MM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21784821 ↗
• MalfunctionApr 7, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED ALINITY C CARBON DIOXIDE FOR ONE PATIENT WITH A HISTORY OF PLASMA CELL DYSCRASIA AND IGG LAMBDA AND OLIGOCLONAL IMMUNOGLOBULINS. THE PATIENT HAD HISTORICAL NORMAL CO2 RESULTS STARTING IN 2002. IN 2019 THE PATIENT HAD A EPP PERFORMED WHICH IDENTIFIED A SMALL DISCREET ABNORMAL BAND. IT WAS ALSO NOTED BEGINNING IN 2019 THAT THE CO2 VALUES WERE LOWER AND BY 2021 THE RESULTS GENERATED WERE <20 MMOL/L. THE PATIENT SAMPLE GENERATED THE LOW RESULTS ON THE ALINITY, BUT WHEN RUN ON THE ROCHE AND A BLOOD GAS ANALYZER, THE CO2 RESULTS WERE NORMAL. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025, SID (B)(6), INITIAL CO2 RESULT (LISMORE FACILITY) = 6.8 MMOL/L; REPEAT RESULT= 7.2 MMOL/L. HISTORICAL RESULTS: (B)(6) 2024, SID (B)(6), INITIAL CO2 RESULT (BOWEN HILLS FACILITY) = 10 MMOL/L. (B)(6) 2025, SID (B)(6), INITIAL CO2 RESULT (BOWEN HILLS FACILITY) = 7 MMOL/L; BLOOD GAS RESULT= 24 MMOL/L (REPORTED). ADDITIONAL INFORMATION WAS PROVIDED ON 17APR2025. THE PATIENT HAD A HISTORY OF DIABETES, ESSENTIAL HYPERTENSION, PRESUMED AUTOIMMUNE HYPOTHYROIDISM, HYPERCHOLESTEROLEMIA, DIVERTICULITIS AND MGUS. THE FOLLOWING HISTORICAL RESULTS WERE PROVIDED: (B)(6) 2019,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21784815 ↗
• MalfunctionApr 7, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED ALINITY C CARBON DIOXIDE FOR ONE PATIENT WITH A HISTORY OF PLASMA CELL DYSCRASIA AND IGG LAMBDA AND OLIGOCLONAL IMMUNOGLOBULINS. THE PATIENT HAD HISTORICAL NORMAL CO2 RESULTS STARTING IN 2002. IN 2019, THE PATIENT HAD AN EPP PERFORMED WHICH IDENTIFIED A SMALL DISCREET ABNORMAL BAND. IT WAS ALSO NOTED BEGINNING IN 2019 THAT THE CO2 VALUES WERE LOWER AND BY 2021 THE RESULTS GENERATED WERE <20 MMOL/L. THE PATIENT SAMPLE GENERATED THE LOW RESULTS ON THE ALINITY, BUT WHEN RUN ON A ROCHE ANALYZER AND A BLOOD GAS ANALYZER, THE CO2 RESULTS WERE NORMAL. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024, SID (B)(6), INITIAL CO2 RESULT (BOWEN HILLS FACILITY) = 10 MMOL/L. (B)(6) 2025, SID (B)(6), INITIAL CO2 RESULT (BOWEN HILLS FACILITY) = 6.36 MMOL/L; BLOOD GAS RESULT= 24 MMOL/L (REPORTED). (B)(6) 2025, SID (B)(6), INITIAL CO2 RESULT (LISMORE FACILITY) = 7 MMOL/L. ADDITIONAL INFORMATION WAS PROVIDED ON 17APR2025. THE PATIENT HAD A HISTORY OF DIABETES, ESSENTIAL HYPERTENSION, PRESUMED AUTOIMMUNE HYPOTHYROIDISM, HYPERCHOLESTEROLEMIA, DIVERTICULITIS AND MGUS. THE FOLLOWING HISTORICAL RESULTS WERE PROVIDED: (B)(6) 2019, CO2= 22 MMOL/L; (B)(6) 2020, CO2= 22

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21784814 ↗
• MalfunctionMar 4, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY C CARBON DIOXIDE. WHEN THE QC WAS RUN ON 4 JAN, ALL 3 LEVELS WERE OOR HIGH. ASSAY CALIBRATION CORRECTED THE QC ISSUE. CUSTOMER THEN PULLED PATIENT SAMPLES RUN PRIOR TO THE CONTROLS AND RETESTING ON ANOTHER ANALYZER (SN (B)(6) OR SN (B)(6) SHOWED A CONSISTENT DROP IN THE VALUES OF 5-6 MMOL/L. THE CUSTOMER PROVIDED THE FOLLOWING DATA: LAB NORMAL REFERENCE RANGES ARE - 2-60 YEARS: 22-29 MMOL/L; >60 YEARS: 23-31 MMOL/L. SAMPLE ID (B)(6), INITIAL RESULT WAS 29 AND RETEST RESULT WAS 23, SAMPLE ID (B)(6), INITIAL RESULT WAS 29 AND RETEST RESULT WAS 22, SAMPLE ID (B)(6), INITIAL RESULT WAS 30 AND RETEST RESULT WAS 23, SAMPLE ID (B)(6), INITIAL RESULT WAS 31 AND RETEST RESULT WAS 24, SAMPLE ID (B)(6), INITIAL RESULT WAS 33 AND RETEST RESULT WAS 25. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21519260 ↗
• MalfunctionDec 12, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY C CO2 RESULTS FOR TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED NORMAL RANGE (22 ¿ 29 MEQ/L): PT 1 INITIAL RESULT <5 MEQ/L, REPEATED 24 MEQ/L, PT2 INITIAL RESULT <5 MEQ/L, REPEATED 28 MEQ/L. BOTH RESULTS WERE AUTO RELEASED. DOCTOR CALLED QUESTIONING RESULTS. CUSTOMER RERAN BOTH SAMPLES ON SAME INSTRUMENT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20917508 ↗