cobas c 111 analyzer 4528778001Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 04015630927036), received between Aug 9, 2018 and May 27, 2026 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (15 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE PHOSPHATE VER.2 RESULT FROM THE COBAS C 111 ANALYZER FOR 1 PATIENT. THE INITIAL RESULT WAS 9.2 MG/DL, AND THE REPEAT RESULT WAS 7.2 MG/DL. AT A DIFFERENT LABORATORY USING AN UNSPECIFIED ANALYZER, THE RESULT WAS 4.3 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299413 ↗
• MalfunctionApr 27, 2026Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLES TESTED WITH CREATININE PLUS VER.2 ON A COBAS C 111 ANALYZER. THE FIRST SAMPLE INITIALLY RESULTED IN A CREATININE VALUE OF 1.05 MG/DL AND IT REPEATED AS 0.69 MG/DL. THE SECOND SAMPLE INITIALLY RESULTED IN A CREATININE VALUE OF 1.14 MG/DL AND 0.86 MG/DL ON (B)(6) 2026. THE CUSTOMER CLEANED THE PROBE, PERFORMED WASHING MAINTENANCE, AND CHANGED THE WATER. THE CUSTOMER THEN REPEATED THE SAMPLE AGAIN, RESULTING IN CREATININE VALUES OF 1.07 MG/DL AND 0.82 MG/DL. THE SAMPLE WAS REPEATED ON A FUJI DRY-CHEM XN700 ANALYZER, RESULTING IN A CREATININE VALUE OF 0.61 MG/DL. THE THIRD SAMPLE INITIALLY RESULTED IN A CREATININE VALUE OF 1.42 MG/DL AND 1.09 MG/DL ON (B)(6) 2026. THE CUSTOMER CLEANED THE PROBE, PERFORMED WASHING MAINTENANCE, AND CHANGED THE WATER. THE CUSTOMER THEN REPEATED THE SAMPLE AGAIN, RESULTING IN CREATININE VALUES OF 1.18 MG/DL AND 1.01 MG/DL. THE SAMPLE WAS REPEATED ON A FUJI DRY-CHEM XN700 ANALYZER, RESULTING IN A CREATININE VALUE OF 0.86 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25003154 ↗
• MalfunctionMar 20, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE HBA1C TQ GEN.3 ASSAY RESULTS FOR THREE PATIENT SAMPLES TESTED ON A COBAS C 111 ANALYZER. TWO PATIENT SAMPLES WITH DISCREPANT RESULTS WERE NOTED FROM THE LIST PROVIDED: PATIENT SAMPLE 1: ON (B)(6) 2026: THE INITIAL RESULT WAS 3.97%. THE REPEAT RESULT WAS 5.85%. PATIENT SAMPLE 2: ON (B)(6) 2026: THE INITIAL RESULT WAS 4.5%. THE REPEAT RESULT WAS 5.5%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650540 ↗
• MalfunctionFeb 17, 2026High Test Results

  THERE WAS AN ALLEGATION OF DISCREPANT RESULTS FOR 2 PATIENT SAMPLES TESTED FOR CALCIUM GEN.2 (CA2) ON A COBAS C 111 ANALYZER. PATIENT 1 INITIAL CA2 RESULT WAS 10.87 MG/DL. THE SAMPLE WAS REPEATED TWICE, WITH RESULTS OF 14.2 MG/DL AND 10.09 MG/DL. ON (B)(6) 2026, PATIENT 2 INITIAL CA2 RESULT WAS 14.8 MG/DL. THE REPEAT RESULT WAS 9.65 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367591 ↗
• MalfunctionDec 29, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH TOTAL PROTEIN GEN.2 MONOCHROMATIC ON A COBAS C 111 ANALYZER. THE FIRST SAMPLE INITIALLY RESULTED IN A TOTAL PROTEIN VALUE OF 9.1 G/DL AND IT REPEATED AS 7.2 G/DL. THE SECOND SAMPLE INITIALLY RESULTED IN A TOTAL PROTEIN VALUE OF 8.2 G/DL AND IT REPEATED AS 6.4 G/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907964 ↗
• MalfunctionDec 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  WE RECEIVED AN ALLEGATION OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR CREATININE JAFFE ON A COBAS C 111 ANALYZER. THE INITIAL RESULT WAS 3.47 MG/DL. THE REPEAT RESULT WAS 0.67 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759597 ↗
• MalfunctionDec 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT ALBUMIN GEN.2 RESULTS FROM THE COBAS C 111 ANALYZER FOR NINE PATIENTS. PATIENT (B)(6) INITIAL RESULT WAS 102.25 MG/L. THE REPEAT RESULT ON 10-NOV-2025, FROM ANOTHER LABORATORY, WAS 58.7 MG/L. PATIENT (B)(6) INITIAL RESULT WAS 28.91 MG/L. THE REPEAT RESULT FROM ANOTHER LABORATORY WAS 20.7 MG/L. PATIENT (B)(6) INITIAL RESULT WAS 34.95 MG/L. THE REPEAT RESULT FROM ANOTHER LABORATORY WAS 21.1 MG/L. PATIENT (B)(6) INITIAL RESULT WAS 55.1 MG/L. THE REPEAT RESULT FROM ANOTHER LABORATORY WAS 27.5 MG/L. PATIENT (B)(6) INITIAL RESULT WAS 237.5 MG/L. THE REPEAT RESULT FROM ANOTHER LABORATORY WAS 343 MG/L. PATIENT (B)(6)INITIAL RESULT WAS 84.3 MG/L. THE REPEAT RESULT FROM ANOTHER LABORATORY WAS LESS THAN 2.50 MG/L. PATIENT (B)(6) INITIAL RESULT WAS 50.7 MG/L. THE REPEAT RESULT FROM ANOTHER LABORATORY WAS 3.01 MG/L. PATIENT (B)(6) INITIAL RESULT WAS 19.5 MG/L. THE REPEAT RESULT FROM ANOTHER LABORATORY WAS 8.62 MG/L. PATIENT (B)(6) INITIAL RESULT WAS 22.4 MG/L. THE REPEAT RESULT FROM ANOTHER LABORATORY WAS 10 MG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706717 ↗
• MalfunctionAug 13, 2025Unable to Obtain Readings; Unable to Obtain Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE TRIGLYCERIDES, BILIRUBIN TOTAL GEN.3, URIC ACID VER.2, AND CALCIUM GEN.2 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS C 111 ANALYZER MODULE. ON (B)(6) 2025, PATIENT 1 HAD AN INITIAL TOTAL BILIRUBIN RESULT OF 19.4 UMOL/L AND A TRIGLYCERIDES RESULT OF 4.61 MMOL/L FROM ANOTHER LABORATORY. THE SAMPLE WAS REPEATED ON THE CUSTOMER'S C111 ANALYZER AND THE TOTAL BILIRUBIN RESULT WAS 14.3 UMOL/L AND THE TRIGLYCERIDES RESULT WAS 3.15 MMOL/L. ON (B)(6) 2025, A SAMPLE FOR PATIENT 2 WAS REPEATED 8 TIMES ON THE C111 ANALYZER. ON (B)(6) 2025, THE SAMPLE HAD TOTAL BILIRUBIN RESULTS OF 29.8 UMOL/L, 28.8 UMOL/L, 28.8 UMOL/L, AND 29.3 UMOL/L. ON (B)(6), THE SAMPLE HAD RESULTS OF 37.8 UMOL/L, 35.4 UMOL/L, 35.4 UMOL/L, AND 35.4 UMOL/L. ON (B)(6) 2025, THE SAMPLE HAD URIC ACID RESULTS OF 278.0 UMOL/L, 279.3 UMOL/L, 282.8 UMOL/L, AND 281.7 UMOL/L. ON (B)(6), THE SAMPLE HAD RESULTS OF 365.2 UMOL/L, 337.3 UMOL/L, 356.7 UMOL/L, AND 348.4 UMOL/L. ON (B)(6), THE SAMPLE HAD CALCIUM RESULTS OF 2.29 MMOL/L, 2.32 MMOL/L, 2.32 MMOL/L, AND 2.32 MMOL/L. ON (B)(6), THE SAMPLE HAD RESULTS OF 2.92 MMOL/L, 2.71 MMOL/L, 2.83 MMOL/L, AND 2.83 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795434 ↗
• MalfunctionJul 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE CREATININE JAFFE GEN.2 (COMPENSATED) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS C 111 ANALYZER. THE INITIAL RESULT WAS 3.7 MG/DL. THE REPEAT RESULT WAS 0.8 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587677 ↗
• MalfunctionJul 18, 2025Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH CREATININE JAFF GEN.2 (CREAJ2) ASSAY AND CHOLESTEROL GEN.2 (CHOL2) ASSAY ON A COBAS C 111 ANALYZER. CREAJ2: INITIAL RESULT: 3.800 MG/DL. REPEAT RESULT: 0.700 MG/DL. CHOL2: INITIAL RESULT: 359.6 MG/DL. REPEAT RESULT: 196.81 MG/DL. DURING THE VALIDATION PROCESS, THE CUSTOMER QUESTIONED THE INITIAL RESULTS AS THEY WERE HIGH. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY, AND THE SAMPLE WAS THEN REPEATED. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22540471 ↗
• MalfunctionJul 2, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE CREA PAP 200T COBAS C111 RESULT FROM THE COBAS C 111 ANALYZER. THE INITIAL RESULT WAS 1.97 MG/DL. THE PATIENT RETURNED ON (B)(6) 2025 AND ANOTHER SAMPLE WAS TAKEN WITH A RESULT OF 0.61 MG/DL. THE INITIAL SAMPLE WAS REPEATED ON (B)(6) 2025 DUE TO THE DIFFERENCE BETWEEN THE RESULTS, AND THE REPEAT RESULT WAS 0.98 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383635 ↗
• MalfunctionJun 9, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE JAFFE GEN.2 (COMPENSATED) RESULTS FROM THE COBAS C 111 ANALYZER. PATIENT 1'S INITIAL RESULT WAS 3.64 MG/DL, AND THE REPEAT RESULT WAS 0.65 MG/DL. THE DOCTOR QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL CONDITION. THE REPEAT RESULT WAS DEEMED TO BE CORRECT. PATIENT 2'S INITIAL RESULT ON (B)(6) 2025 WAS 3.91 MG/DL, AND THE REPEAT RESULT WAS 0.94 MG/DL. THE REPEAT RESULT WAS DEEMED TO BE CORRECT. THE INITIAL RESULT WAS NOT RELEASED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165972 ↗
• MalfunctionMay 20, 2025Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH CREATININE PLUS VER.2 ASSAY AND 1 PATIENT SAMPLE TESTED WITH URIC ACID ASSAY ON A COBAS C 111 ANALYZER. PATIENT 1 TESTED FOR CREATININE: INITIAL RESULT: 1.82 MG/DL. REPEAT RESULT: 39.98 MG/DL. PATIENT 2 TESTED FOR URIC ACID: INITIAL RESULT: 0.64 MG/DL ACCOMPANIED BY A QC ALARM. REPEAT RESULT: 6.56 MG/DL. THE INITIAL RESULTS DID NOT MATCH THE PATIENTS' HISTORY, AND THE SAMPLES WERE REPEATED ON (B)(6) 2025. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT AS THEY MATCHED THE PATIENTS' PREVIOUS RESULTS. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22055083 ↗
• MalfunctionApr 18, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE HBA1C TQ GEN.3 (HBA1C) RESULTS FROM SEVERAL PATIENT SAMPLES TESTED ON THE COBAS C 111 ANALYZER. ONE PATIENT SAMPLE WITH DISCREPANT RESULTS WAS PROVIDED: ON (B)(6) 2025: THE INITIAL RESULT FROM THE ANALYZER WAS 7.2% THE FIRST REPEAT RESULT FROM THE ANALYZER WAS 5.6%. THE SECOND REPEAT RESULT FROM THE ANALYZER WAS 7.4%. ON (B)(6) 2025: THE THIRD REPEAT RESULT FROM A C 303 ANALYZER ON A DIFFERENT SITE WAS 5.6% OR 5.8%. THE PATIENT SAMPLE WAS RERUN BECAUSE OF THE PATIENT'S MEDICAL HISTORY. THE RESULT OF 5.6% WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21864541 ↗
• MalfunctionApr 1, 2025Material Integrity Problem; Material Integrity Problem

  THERE WAS AN ALLEGATION OF A QUESTIONABLE GLUCOSE RESULT FROM THE COBAS C 111 ANALYZER. THE INITIAL RESULT WAS 109.84 MG/DL AND THE REPEAT RESULT WAS 81.61 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741814 ↗
• MalfunctionFeb 10, 2025Output Problem; Output Problem

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE CREATININE (CREAP2) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS C 111 ANALYZER. ON (B)(6) 2025: THE INITIAL RESULT OF THE INITIAL SAMPLE WAS 258.0 UMOL/L WITH A DATA FLAG. THE INITIAL RESULT OF A REPEAT SAMPLE WAS 71.2 UMOL/L. ON (B)(6) 2025: THE FIRST REPEAT RESULT OF THE INITIAL SAMPLE WAS 76.6 UMOL/L. THE SECOND REPEAT RESULT OF THE INITIAL SAMPLE WAS 73.3 UMOL/L. THE REPEAT RESULT OF THE REPEAT SAMPLE FROM ANOTHER LABORATORY WAS 74.6 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343320 ↗
• MalfunctionMay 9, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH GLUCOSE HK (GLUC2) ASSAY ON A COBAS C111 ANALYZER. SAMPLE 1: INITIAL RESULT: 188.89 MG/DL. 1ST REPEAT RESULT: 95.53 MG/DL. 2ND REPEAT RESULT: 95.57 MG/DL. SAMPLE 2: INITIAL RESULT: 199.05 MG/DL. 1ST REPEAT RESULT: 92.42 MG/DL. 2ND REPEAT RESULT: 91.61 MG/DL. THE CUSTOMER QUESTIONED THE INITIAL RESULTS AS THEY DID NOT MATCH THE PATIENTS' CLINICAL CONDITIONS. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND THE SAMPLES WERE REPEATED. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19276769 ↗
• MalfunctionFeb 19, 2024Incorrect, Inadequate or Imprecise Result or Readings; Optical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Optical Problem

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE CREJ2 CREATININE JAFFÉ GEN.2 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS C 111 ANALYZER. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE CLINICIAN REQUESTED A RERUN AND A NEW SAMPLE WAS ALSO COLLECTED FROM THE PATIENT. ON (B)(6) 2024: THE INITIAL RESULT OF THE INITIAL PATIENT SAMPLE WAS 4.1 MG/DL OR 4.7 MG/DL. ON (B)(6) 2024: THE REPEAT RESULT OF THE INITIAL PATIENT SAMPLE WAS 1.1 MG/DL. THE REPEAT RESULT WAS DEEMED CORRECT AS THE RESULT OF THE NEW PATIENT SAMPLE WAS 1 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730102 ↗
• MalfunctionOct 24, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S PLASMA SAMPLE TESTED WITH CREATININE JAFFÉ GEN.2 (CREAJ2) ASSAY ON A COBAS C111 ANALYZER. INITIAL RESULT: 3.19 MG/DL. 1ST REPEAT RESULT: 0.82 MG/DL (MANUAL). 2ND RERUN RESULT: 0.53 MG/DL. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE 2ND REPEAT RESULT OF 0.53 MG/DL WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995560 ↗
• MalfunctionMay 11, 2023Fire; Fire

  THE CUSTOMER ALLEGED THAT ON (B)(6) 2023, SOMETIME AROUND 11 A.M. THE COBAS C111 ANALYZER CAUGHT ON FIRE. NO INJURY WAS ALLEGED AND NO DAMAGE TO OTHER EQUIPMENT OR SURROUNDINGS IN THE LABORATORY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16912011 ↗
• MalfunctionMay 15, 2022High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ALP2S ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 ON A COBAS C 111. THE SAMPLE INITIALLY RESULTED IN AN ALP VALUE OF 412 U/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE PATIENT. THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING AND ALP TESTING OF THE SAMPLE WAS REPEATED TWICE ON AN UNKNOWN ANALYZER, RESULTING IN VALUES OF 188 U/L AND 182 U/L. THE SAMPLE WAS TRANSFERRED BACK TO THE CUSTOMER'S LABORATORY AND IT WAS REPEATED ON THE C 111 ANALYZER ON (B)(6) 2022, RESULTING IN A VALUE OF 186 U/L. THE SAMPLE WAS ALSO REPEATED ON A COBAS 4000 C (311) STAND ALONE SYSTEM AT THE CUSTOMER SITE, RESULTING IN A VALUE OF 189 U/L. THE ALP REAGENT LOT NUMBER WAS 57010401. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14403808 ↗
• MalfunctionApr 11, 2022Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CREJ2 CREATININE JAFFÉ GEN.2 (COMPENSATED) ON A COBAS C 111. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A CREATININE VALUE OF 1.16 MG/DL. THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 1.63 MG/DL AND 1.58 MG/DL. THE CREATININE REAGENT LOT NUMBER WAS 57929101, WITH AN EXPIRATION DATE 30-JUN-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14077399 ↗
• MalfunctionMar 21, 2022False Positive Result; False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH CREJ2 CREATININE JAFFÉ GEN.2 (COMPENSATED) ON A COBAS C 111. THE SAMPLE INITIALLY RESULTED IN A CREATININE VALUE OF 4.6 MG/DL AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE CLINICIAN. THE CLINICIAN QUESTIONED THE RESULT. ON 02-MAR-2022, THE REAGENT BOTTLE HAD 8 TESTS REMAINING AND WAS REPLACED. THE SAMPLE WAS THEN REPEATED ON 02-MAR-2022, RESULTING IN A VALUE OF 1.0 MG/DL. THE SECOND SAMPLE INITIALLY RESULTED IN A CREATININE VALUE OF 5.8 MG/DL ON 10-MAR-2022 AND REPEATED AS 0.9 MG/DL ON 10-MAR-2022 . NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY FOR THIS SAMPLE. THE CREATININE REAGENT LOT NUMBER WAS 57929101, WITH AN EXPIRATION DATE OF 30-JUN-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13838882 ↗
• MalfunctionMar 17, 2022False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH GGT-2 GAMMA-GLUTAMYLTRANSFERASE VER.2 RESULTS FROM THE COBAS C111 ANALYZER. SAMPLE 1 INITIAL RESULT WAS 138.4 KU/L AND THE REPEAT RESULT WAS 9.1 KU/L. FROM A COBAS C501 ANALYZER, THE RESULT WAS 11 KU/L. ON (B)(6) 2022, SAMPLE 2 INITIAL RESULT WAS 87.5 KU/L AND THE REPEAT RESULT WAS 26.5 KU/L. FROM A COBAS C501 ANALYZER, THE RESULT WAS 23 KU/L. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13800440 ↗
• MalfunctionMar 7, 2022Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CREJ2 CREATININE JAFFÉ GEN.2 (COMPENSATED) ON A COBAS C 111. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A CREATININE VALUE OF 2.68 MG/DL AND REPEATED AS 0.44 MG/DL. THE CREATININE REAGENT LOT NUMBER WAS 57929101, WITH AN EXPIRATION DATE OF 30-JUN-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13685416 ↗