cobas c 111 analyzer with ISE 04777433001Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 04015630924769), received between Jan 28, 2019 and Feb 17, 2026 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (10 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER COMPLAINED OF QC ISSUES AND DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR CREATININE PLUS VER.2 (CREP2) ON A C 111 ANALYZER WITH ISE. THE INITIAL RESULT WAS 1.4 MG/DL. THE REPEAT RESULT WAS 0.83 MG/DL. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367567 ↗
• MalfunctionJan 12, 2026Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ION-SELECTIVE ELECTRODE (ISE) SODIUM ELECTRODE RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS C 111 ANALYZER WITH ISE. INITIAL RESULT: 129 MMOL/L. THE CUSTOMER NOTICED THAT THE INITIAL RESULT WAS LOWER THAN EXPECTED AND SENT THE SAMPLE TO A REFERENCE LABORATORY, WHERE IT WAS REPEATED ON A COBAS 8000 COBAS ISE MODULE. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. 1ST REPEAT RESULT: 130 MMOL/L. 2ND REPEAT RESULT: 137 MMOL/L. THE REPEAT RESULT OF 130 MMOL/L WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24040056 ↗
• MalfunctionDec 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE SODIUM ELECTRODE ON A COBAS C 111 WITH ISE. THE CUSTOMER STATED THEY HAVE BEEN HAVING ONGOING ISSUES WITH THE ISE TESTS ON THE ANALYZER. THE PATIENT SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 131 MMOL/L. THE CUSTOMER HAD BEEN MONITORING RESULTS DUE TO ONGOING ISSUES AND QUESTIONED THE LOW VALUE. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 140 MMOL/L. THE REPEAT VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23869997 ↗
• MalfunctionAug 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 2 SAMPLES FROM 1 PATIENT TESTED FOR BILIRUBIN TOTAL GEN.3 (BILT3) ON A COBAS C 111 ANALYZER WITH ISE. SAMPLE 1: THE INITIAL RESULT FROM THE (B)(6) ANALYZER WAS 0.10 MG/DL. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 0.02 MG/DL AND [-] 0.00 MG/DL WITH AN INVALIDATING DATA FLAG. THE SAMPLE WAS REPEATED ON A COBAS 8000 SYSTEM WITH A RESULT OF 0.09 MG/DL. SAMPLE 2: THE INITIAL RESULT FROM THE (B)(6) ANALYZER WAS 0.38 MG/DL. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 0.50 MG/DL AND 0.38 MG/DL. THE SAMPLE WAS REPEATED ON A COBAS 8000 SYSTEM WITH A RESULT OF 0.36 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784738 ↗
• MalfunctionJun 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE POTASSIUM RESULTS FROM THE COBAS C 111 WITH ISE ANALYZER. SAMPLE (B)(6) INITIAL RESULT WAS 5.2 MMOL/L, AND THE REPEAT RESULT WAS 4.3 MMOL/L. SAMPLE (B)(6) INITIAL RESULT WAS 3.7 MMOL/L, AND THE REPEAT RESULT WAS 5.1 MMOL/L. SAMPLE (B)(6) INITIAL RESULT WAS 3.8 MMOL/L, AND THE REPEAT RESULT WAS 4.6 MMOL/L. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22326951 ↗
• MalfunctionFeb 11, 2025Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 3 PATIENT SAMPLES TESTED FOR MULTIPLE ASSAYS ON A COBAS C 111 ANALYZER WITH ISE. DISCREPANT RESULTS WERE IDENTIFIED FOR CREATININE PLUS VER.2 (CREA2), TINA-QUANT C-REACTIVE PROTEIN IV (CRP4), BILIRUBIN TOTAL GEN. 3 (BILT3), ALKALINE PHOSPHATASE (ALP2S) AND ASPARTATE AMINOTRANSFERASE WITH/WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (AST). THIS MEDWATCH WILL COVER AST. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CREA2 RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CRP4 RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE BILT3 RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ALP2S RESULTS. PATIENT 1 INITIAL CRP4 RESULT WAS 0.21 MG/L. THE REPEAT RESULT WAS 6.1 MG/L. ON (B)(6)2025 PATIENT 2 INITIAL CREA2 RESULT WAS 1.6 UMOL/L. THE REPEAT RESULT WAS 84 UMOL/L. ON (B)(6)2025 THE REPEAT RESULT WAS 85 UMOL/L. THE INITIAL CRP4 RESULT WAS 3.46 MG/L. THE REPEAT RESULT WAS 215.9 MG/L. ON (B)(6)2025 THE REPEAT RESULT WAS 217 MG/L. THE INITIAL BILT3 RESULT WAS 0.8 UMOL/L. THE REPEAT RESULT WAS 17.4 UMOL/L. THE INITIAL ALKALINE PHOSPHATASE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355044 ↗
• MalfunctionFeb 11, 2025Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 3 PATIENT SAMPLES TESTED FOR MULTIPLE ASSAYS ON A COBAS C 111 ANALYZER WITH ISE. DISCREPANT RESULTS WERE IDENTIFIED FOR CREATININE PLUS VER.2 (CREA2), TINA-QUANT C-REACTIVE PROTEIN IV (CRP4), BILIRUBIN TOTAL GEN. 3 (BILT3), ALKALINE PHOSPHATASE (ALP2S) AND ASPARTATE AMINOTRANSFERASE WITH/WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (AST). THIS MEDWATCH WILL COVER CRP4. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CREA2 RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE BILT3 RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ALP2S RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE AST RESULTS. PATIENT 1 INITIAL CRP4 RESULT WAS 0.21 MG/L. THE REPEAT RESULT WAS 6.1 MG/L. ON (B)(6) 2025 PATIENT 2 INITIAL CREA2 RESULT WAS 1.6 UMOL/L. THE REPEAT RESULT WAS 84 UMOL/L. ON (B)(6) 2025 THE REPEAT RESULT WAS 85 UMOL/L. THE INITIAL CRP4 RESULT WAS 3.46 MG/L. THE REPEAT RESULT WAS 215.9 MG/L. ON (B)(6) 2025 THE REPEAT RESULT WAS 217 MG/L. THE INITIAL BILT3 RESULT WAS 0.8 UMOL/L. THE REPEAT RESULT WAS 17.4 UMOL/L. THE INITIAL ALKALINE PHOSPHATA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355037 ↗
• MalfunctionFeb 11, 2025Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 3 PATIENT SAMPLES TESTED FOR MULTIPLE ASSAYS ON A COBAS C 111 ANALYZER WITH ISE. DISCREPANT RESULTS WERE IDENTIFIED FOR CREATININE PLUS VER.2 (CREA2), TINA-QUANT C-REACTIVE PROTEIN IV (CRP4), BILIRUBIN TOTAL GEN. 3 (BILT3), ALKALINE PHOSPHATASE (ALP2S) AND ASPARTATE AMINOTRANSFERASE WITH/WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (AST). THIS MEDWATCH WILL COVER CREA2. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CRP4 RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE BILT3 RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ALP2S RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE AST RESULTS. PATIENT 1 INITIAL CRP4 RESULT WAS 0.21 MG/L. THE REPEAT RESULT WAS 6.1 MG/L. ON (B)(6) 2025 PATIENT 2 INITIAL CREA2 RESULT WAS 1.6 UMOL/L. THE REPEAT RESULT WAS 84 UMOL/L. ON (B)(6) 2025 THE REPEAT RESULT WAS 85 UMOL/L. THE INITIAL CRP4 RESULT WAS 3.46 MG/L. THE REPEAT RESULT WAS 215.9 MG/L. ON (B)(6) 2025 THE REPEAT RESULT WAS 217 MG/L. THE INITIAL BILT3 RESULT WAS 0.8 UMOL/L. THE REPEAT RESULT WAS 17.4 UMOL/L. THE INITIAL ALKALINE PHOSPHATA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355036 ↗
• MalfunctionFeb 11, 2025Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 3 PATIENT SAMPLES TESTED FOR MULTIPLE ASSAYS ON A COBAS C 111 ANALYZER WITH ISE. DISCREPANT RESULTS WERE IDENTIFIED FOR CREATININE PLUS VER.2 (CREA2), TINA-QUANT C-REACTIVE PROTEIN IV (CRP4), BILIRUBIN TOTAL GEN. 3 (BILT3), ALKALINE PHOSPHATASE (ALP2S) AND ASPARTATE AMINOTRANSFERASE WITH/WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (AST). THIS MEDWATCH WILL COVER ALP2S. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CREA2 RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CRP4 RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE BILT3 RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE AST RESULTS. PATIENT 1 INITIAL CRP4 RESULT WAS 0.21 MG/L. THE REPEAT RESULT WAS 6.1 MG/L. ON (B)(6) 2025 PATIENT 2 INITIAL CREA2 RESULT WAS 1.6 UMOL/L. THE REPEAT RESULT WAS 84 UMOL/L. ON (B)(6) 2025 THE REPEAT RESULT WAS 85 UMOL/L. THE INITIAL CRP4 RESULT WAS 3.46 MG/L. THE REPEAT RESULT WAS 215.9 MG/L. ON (B)(6) 2025 THE REPEAT RESULT WAS 217 MG/L. THE INITIAL BILT3 RESULT WAS 0.8 UMOL/L. THE REPEAT RESULT WAS 17.4 UMOL/L. THE INITIAL ALKALINE PHOSPHATA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355035 ↗
• MalfunctionFeb 11, 2025Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 3 PATIENT SAMPLES TESTED FOR MULTIPLE ASSAYS ON A COBAS C 111 ANALYZER WITH ISE. DISCREPANT RESULTS WERE IDENTIFIED FOR CREATININE PLUS VER.2 (CREA2), TINA-QUANT C-REACTIVE PROTEIN IV (CRP4), BILIRUBIN TOTAL GEN. 3 (BILT3), ALKALINE PHOSPHATASE (ALP2S) AND ASPARTATE AMINOTRANSFERASE WITH/WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (AST). THIS MEDWATCH WILL COVER BILT3. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CREA2 RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CRP4 RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ALP2S RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE AST RESULTS. PATIENT 1 INITIAL CRP4 RESULT WAS 0.21 MG/L. THE REPEAT RESULT WAS 6.1 MG/L. ON (B)(6)2025 PATIENT 2 INITIAL CREA2 RESULT WAS 1.6 UMOL/L. THE REPEAT RESULT WAS 84 UMOL/L. ON (B)(6)2025 THE REPEAT RESULT WAS 85 UMOL/L. THE INITIAL CRP4 RESULT WAS 3.46 MG/L. THE REPEAT RESULT WAS 215.9 MG/L. ON (B)(6)2025 THE REPEAT RESULT WAS 217 MG/L. THE INITIAL BILT3 RESULT WAS 0.8 UMOL/L. THE REPEAT RESULT WAS 17.4 UMOL/L. THE INITIAL ALKALINE PHOSPHATASE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355034 ↗
• MalfunctionDec 10, 2024Failure to Calibrate; Failure to Calibrate

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ISE RESULTS FOR 4 PATIENTS' SAMPLES TESTED ON A COBAS C111 WITH AN ISE ANALYZER WHEN COMPARED TO A DIFFERENT LABORATORY. RESULTS FOR THE SODIUM (NA) TEST WERE AFFECTED. SAMPLE 1 (PATIENT 1): INITIAL RESULT: 128.6 MMOL/L. REPEAT RESULT: 135.89 MMOL/L. SAMPLE 2, SAMPLE 3, AND SAMPLE 4 WERE TESTED ON (B)(6) 2024: SAMPLE 2 (PATIENT 2): INITIAL RESULT: 127 MMOL/L. REPEAT RESULT: 142 MMOL/L. SAMPLE 3 (PATIENT 3): INITIAL RESULT: 129.3 MMOL/L. REPEAT RESULT: 140.72 MMOL/L. SAMPLE 4 (PATIENT 4): INITIAL RESULT: 129.6 MMOL/L. REPEAT RESULT: 139.26 MMOL/L. THE PHYSICIAN QUESTIONED THE INITIAL RESULTS AFTER SENDING NEW PATIENTS' DRAW TO ANOTHER LABORATORY. SAMPLE 1, SAMPLE 3, AND SAMPLE 4 WERE THEN REPEATED ON (B)(6) 2024. THE RESULTS OBTAINED FROM THE OTHER LABORATORY WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892520 ↗
• MalfunctionMar 22, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA RESULTS FOR 2 PATIENT SAMPLES ON A COBAS C 111 MODULE. THE CUSTOMER WAS PROMPTED TO REPEAT THE SAMPLES ON ANOTHER ANALYZER AS THEY HAD REPLACED ALL ISE ELECTRODES PRIOR TO PATIENT SAMPLE TESTING. FOR PATIENT 1, THE INITIAL NA RESULT WAS 132 MMOL/L. THE SAMPLE WAS REPEATED ON A C8000 ANALYZER AND THE RESULT WAS 138 MMOL/L. THE SAMPLE WAS REPEATED ON THE C111 ANALYZER AND THE RESULT WAS 134.7 MMOL/L. FOR PATIENT 2, THE INITIAL NA RESULT WAS 132 MMOL/L. THE SAMPLE WAS REPEATED ON A C8000 ANALYZER AND THE RESULT WAS 138 MMOL/L. THE SAMPLE WAS REPEATED ON THE C111 ANALYZER AND THE RESULT WAS 136.8 MMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18959786 ↗
• MalfunctionSep 11, 2023Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT NA FOR GEN.2 RESULTS FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS C 111 WITH ISE. THE REPORTER STATED THEY CHANGED THE SODIUM AND REFERENCE ELECTRODE LAST WEEK BECAUSE THEIR ION-SELECTIVE ELECTRODE (ISE) CALIBRATIONS WOULD OFTEN FAIL SEVERAL TIMES. THE QC RESULTS WOULD PASS AFTER A SUCCESSFUL CALIBRATION. THE REPORTER STATED THAT THEY HAVE HIGH/UNSTABLE SODIUM PATIENT RESULTS FROM THE ANALYZER. THE REPORTER WAS ABLE TO PROVIDE THE FOLLOWING EXAMPLES OF DISCREPANT RESULTS: SAMPLE 1: ON (B)(6) 2023, THE INITIAL SODIUM RESULT WAS 147 MMOL/L. THIS RESULT WAS REPORTED. THE REPEAT RESULT WAS 138.5 MMOL/L. SAMPLE 2: ON (B)(6) 2023, THE INITIAL SODIUM RESULT WAS 124.7 MMOL/L WITH A DATA FLAG. THE FIRST REPEAT RESULT WAS 148.4 MMOL/L. THE SECOND REPEAT RESULT WAS 137.0 MMOL/L. THE THIRD REPEAT RESULT WAS 138.2 MMOL/L. THIS RESULT WAS REPORTED. SAMPLE 3: THE INITIAL SODIUM RESULT WAS 185 MMOL/L WITH A DATA FLAG. THE FIRST REPEAT RESULT WAS 155 MMOL/L. THE SECOND REPEAT RESULT WAS 150 MMOL/L. THE THIRD REPEAT RESULT WAS 139 MMOL/L. SAMPLE 4: THE INITIAL SODIUM RESULT WAS 150 MMOL/L. THE REPEAT RESULT WAS 141 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17718979 ↗
• MalfunctionSep 1, 2023Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR SODIUM (NA) ON A COBAS C 111 INSTRUMENT. THE INITIAL RESULT WAS 162 MMOL/L. THE REPEAT RESULT WAS 130 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17672649 ↗
• MalfunctionMay 22, 2023False Negative Result; False Negative Result

  THE INITIAL REPORTER QUESTIONED LOW RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED FOR SODIUM (NA) ON A COBAS C 111 INSTRUMENT. THE CUSTOMER PROVIDED AN EXAMPLE OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE. THE INITIAL RESULT WAS 121 MMOL/L. THE SAMPLE WAS REPEATED 4 TIMES WITH RESULTS OF 124 MMOL/L, 126 MMOL/L, 130 MMOL/L, AND 131 MMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE NA ELECTRODE LOT NUMBER WITH EXPIRATION DATE WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16978833 ↗
• MalfunctionJan 23, 2023Incorrect, Inadequate or Imprecise Result or Readings; Material Integrity Problem; Incorrect, Inadequate or Imprecise Result or Readings; Material Integrity Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE A1C-3 TINA-QUANT HEMOGLOBIN A1C GEN.3 - WHOLE BLOOD AND HEMOLYSATE APPLICATION RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 111 WITH ISE MODULE COMPARED TO A DCA VANTAGE ANALYZER. THE INITIAL A1C-3 RESULT ON THE C111 ANALYZER WAS 10.30%. THE HEMOGLOBIN A1C RESULT ON THE DCA ANALYZER WAS 11.9%. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16228118 ↗
• MalfunctionJan 20, 2023Incorrect Measurement; Incorrect Measurement

  THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 111 WITH ISE MODULE. THE INITIAL NA RESULT WAS 123.7 MMOL/L. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER REPEATED THE SAMPLE DUE TO ONGOING UNSTABLE ISE ERRORS ON THE ANALYZER. THE REPEAT RESULT WAS 135.2 MMOL/L. THE NA ELECTRODE LOT AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218608 ↗
• MalfunctionApr 4, 2022High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT GEN.2 NA RESULTS FOR SEVEN PATIENTS TESTED ON A COBAS C 111 ANALYZER WITH ISE. THE REPORTER STATED THE FIELD SERVICE ENGINEER PREVIOUSLY SERVICED THE C 111 ANALYZER. DUE TO HIGH NA RESULTS, THE REPORTER COMPLETED A CORRELATION STUDY WITH PATIENT SAMPLES. PRIOR TO PATIENT TESTING, THE REPORTER CONFIRMED THE QC WAS ACCEPTABLE ON THE C 111 ANALYZER. THE SAMPLES WERE INITIALLY TESTED ON THE REPORTERS C 111 ANALYZER AND THEN THE SAMPLES WERE SENT TO TWO DIFFERENT LABORATORIES FOR TESTING ON A COBAS 6000 C (501) MODULE AND A C 111 ANALYZER. THE CUSTOMER WAS UNSURE WHICH NA RESULT WAS REPORTED OUTSIDE THE LABORATORY FOR EACH PATIENT BUT DETERMINED THE RESULTS AT THE OTHER FACILITIES WERE CORRECT. (B)(6). THE NA ELECTRODE LOT NUMBER WAS 21514366 AND THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13995243 ↗
• MalfunctionMar 7, 2022Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH GGT-2-GLUTAMYL TRANSFERASE VER.2 STANDARDIZED AGAINST IFCC / SZASZ ON A COBAS C 111. THE SAMPLE INITIALLY RESULTED IN A GGT VALUE OF 362.4 U/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON (B)(6) 2022, RESULTING IN A VALUE OF 9.9 U/L. THE REPEAT VALUE AGREED WITH THE PATIENT'S CLINICAL PICTURE. THE GGT REAGENT LOT NUMBER WAS 530461-01. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13685033 ↗
• MalfunctionFeb 24, 2022False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT GEN.2 SODIUM RESULTS FROM THE COBAS C 111 WITH ISE ANALYZER. THE SAMPLES WERE REPEATED ON A COBAS C501 ANALYZER AT ANOTHER SITE. PATIENT 1 INITIAL RESULT WAS 132 MMOL/L AND THE REPEAT RESULT WAS 140 MMOL/L. PATIENT 2 INITIAL RESULT WAS 129 MMOL/L AND THE REPEAT RESULT WAS 137 MMOL/L. PATIENT 3 INITIAL RESULT WAS 132 MMOL/L AND THE REPEAT RESULT WAS 140 MMOL/L. IT WAS REQUESTED BUT WAS NOT KNOWN IF ANY OF THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13590242 ↗
• MalfunctionFeb 22, 2022Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH GGT-2-GLUTAMYL TRANSFERASE VER.2 STANDARDIZED AGAINST IFCC / SZASZ ON A COBAS C 111. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A GGT VALUE OF 505.6 U/L. THE SAMPLE WAS REPEATED ON A REFLOTRON ANALYZER, RESULTING IN A VALUE OF 13.9 U/L. THE SAMPLE WAS ALSO REPEATED ON THE C 111 ANALYZER, RESULTING IN A VALUE OF 13.2 U/L. THE 13.2 U/L VALUE WAS DEEMED CORRECT. THE GGT REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13578226 ↗
• MalfunctionFeb 16, 2022Low Test Results; Low Test Results

  THERE WAS A COMPLAINT OF QUESTIONABLE ISE SODIUM RESULTS FOR 2 PATIENTS TESTED WITH A COBAS C111 MODULE. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. PATIENT 1¿S INITIAL RESULT WAS 118 MMOL/L; THE REPEAT WAS 135 MMOL/L. PATIENT 2¿S INITIAL RESULT WAS 122 MMOL/L; THE REPEAT WAS 137 MMOL/L. THE CUSTOMER BELIEVES THE REPEATED RESULT TO BE CORRECT. THE SODIUM ELECTRODE USED WAS LOT 21512647 AND HAD AN INSTALLATION DATE OF (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13541340 ↗
• MalfunctionDec 21, 2021Non Reproducible Results; Non Reproducible Results

  THERE WAS A COMPLAINT OF QUESTIONABLE ISE POTASSIUM ELECTRODE RESULTS FOR 1 PATIENT TESTED WITH A COBAS C111 WITH ISE MODULE. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS TESTED ON 2 C111¿S (MODULES A AND B) AND ONE REFLOTRON ANALYZER. THE PATIENT¿S INITIAL RESULT ON MODULE A WAS 5.53 MMOL/L; THE REPEAT ON MODULE B WAS 3.83 MMOL/L, THE THIRD REPEAT ON THE REFLOTRON WAS 3.76 MMOL/L. THE LOT NUMBER AND EXPIRATION DATE OF THE ISE POTASSIUM ELECTRODE USED WERE REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13052812 ↗
• MalfunctionDec 20, 2021Output Problem; Output Problem

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 2 PATIENT SAMPLES TESTED FOR GAMMA-GLUTAMYLTRANSFERASE VER.2 (GGT-2) ON A COBAS C 111 ANALYZER. "PATIENT 3" INITIAL RESULT WAS 0.75 UKAT/L. THE REPEAT RESULTS WERE 0.29 UKAT/L AND 0.23 UKAT/L. ON (B)(6) 2021 "PATIENT 1" INITIAL RESULT WAS 1.08 UKAT/L. THE REPEAT RESULTS WERE 0.33 UKAT/L AND 0.28 UKAT/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE GGT-2 REAGENT LOT NUMBER WAS 57220401 WITH AN EXPIRATION DATE OF 31-MAY-2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13044038 ↗
• MalfunctionOct 4, 2021Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT NA, K, FOR GEN.2 RESULTS FOR ONE PATIENT SAMPLE WITH THE COBAS C 111. THE INITIAL NA RESULT WAS 129 MMOL/L. THE REPEATED RESULT PER LABORATORY POLICY WAS 129 MMOL/L. THE PATIENT WAS SENT TO ANOTHER FACILITY AND RECEIVED A NA RESULT OF 139 MMOL/L. THE CUSTOMER REPEATED THE SAMPLE A SECOND TIME WITH A NA RESULT OF 129 MMOL/L. THE SAMPLE WAS SENT TO A SISTER LABORATORY AND TESTED WITH A COBAS 6000 WITH A NA RESULT OF 137 MMOL/L. THE INITIAL K RESULT WAS 4.1 MMOL/L. THE REPEATED RESULT WAS 4.7 MMOL/L. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REPEATED RESULTS (NA OF 137 MMOL/L AND K OF 4.7 MMOL/L) WERE DEEMED CORRECT. THE NA ELECTRODE LOT NUMBER WAS 21511663 WITH AN EXPIRATION DATE OF 22-OCT-2021. THE K ELECTRODE LOT NUMBER WAS 21511165 WITH AN EXPIRATION DATE OF 17-SEP-2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12567244 ↗