Creatinine plus ver2 5168589190Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04015630924998), received between Aug 23, 2018 and Sep 30, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (14 reports).

2 other recalls cover devices cleared under the same FDA submission (K024098); they may or may not involve this specific model.

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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949998 ↗
• MalfunctionSep 2, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50570995 ↗
• MalfunctionDec 23, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 RESULTS FOR QC AND PATIENT SAMPLES FROM THE COBAS 8000 COBAS C 701 MODULE. ONE EXAMPLE WAS AN INITIAL RESULT OF 0.79 MG/DL AND A REPEAT RESULT OF 0.96 MG/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881688 ↗
• MalfunctionDec 21, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR CREATININE PLUS VER.2 (CREP2) ON A COBAS 8000 COBAS C 701 MODULE. THE INITIAL RESULT WAS 9.94 MG/DL. THE PHYSICIAN QUESTIONED THIS RESULT. THE SAMPLE WAS REPEATED ON A DIFFERENT C MODULE WITH A RESULT OF 1.34 MG/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23860439 ↗
• MalfunctionDec 1, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 (CREP) RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C702 MODULE. AN INTERFERENCE WITH THE CREATININE PLUS VER.2 ASSAY WAS SUSPECTED. THE INITIAL RESULT WAS 97 UMOL/L. THE PHYSICIAN QUESTIONED THE RESULT BECAUSE IT DIDN'T MATCH THE PATIENT'S CLINICAL CONDITION. THE SAMPLE WAS REPEATED ON AN AU ANALYZER (BECKMAN COULTER), AND THE RESULTS WERE 201 UMOL/L AND 197 UMOL/L. THESE RESULTS WERE BELIEVED TO BE CORRECT. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 8000 C702 MODULE, AND THE RESULT WAS 93 UMOL/L. ON (B)(6) 2025, THE SAMPLE WAS REPEATED ON THE SAME COBAS 8000 C702 MODULE AS THE INITIAL RESULT. THE CREP ASSAY RESULT WAS 94 UMOL/L, AND THE CRE-J ASSAY RESULT WAS 212 UMOL/L. THE SAMPLE WAS REPEATED WITH THE CREP ASSAY ON A COBAS C503 MODULE, AND THE RESULT WAS 96.1 UMOL/L. THE CREATININE ASSAY USED ON THE COBAS 8000 C702 MODULE WAS CREP (ENZYMATIC ASSAY), WHILE THE ASSAY USED ON THE AU ANALYZER WAS CRE-J.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23684655 ↗
• MalfunctionNov 4, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CREATININE PLUS VER.2 ON A COBAS 8000 C 701 MODULE. THE SAMPLE INITIALLY RESULTED IN A CREATININE RESULT OF 6.48 MG/DL. THE VALUE WAS QUESTIONED BY THE PATIENT'S PROVIDER AS THE VALUE DID NOT AGREE WITH THE PATIENT'S HISTORY AND A VALUE OF 4.16 MG/DL MEASURED FROM A SECOND SAMPLE COLLECTED FROM THE PATIENT. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A CREATININE VALUE OF 4.3 MG/DL. THE REPEAT VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468609 ↗
• MalfunctionApr 25, 2025Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLES TESTED WITH CREATININE PLUS VER.2 (CREP2) ASSAY ON A COBAS 8000 C702 MODULE WHEN COMPARED TO A COBAS C501 MODULE AND ARCHITECT SYSTEM. SAMPLE 1 WAS INITIALLY TESTED ON C501 RESULTING IN VALUES OF 325 UMOL/L AND 336 UMOL/L. SAMPLE 1 WAS REPEATED USING A DILUTION FACTOR OF 1:50 ON THE C501 AND THE RESULT WAS 355 UMOL/L (ACCOMPANIED BY A DATA FLAG). THE PHYSICIAN QUESTIONED THE RESULT OF 325 UMOL/L AS IT DID NOT CORRELATE WITH THE PATIENT'S CLINICAL PICTURE AND REQUESTED A 2ND SAMPLE (SAMPLE 2) TO BE DRAWN. SAMPLE 2 WAS TESTED ON THE C501 RESULTING IN VALUES OF 34 UMOL/L AND 35 UMOL/L. SAMPLE 1 WAS THEN REPEATED RESULTING IN VALUES OF: 24 UMOL/L AND 27 UMOL/L WHEN TESTED ON C702. 411.2 UMOL/L WHEN TESTED ON ARCHITECT. SAMPLE 2 WAS ALSO REPEATED ON C702 AND ARCHITECT RESULTING IN VALUES AROUND 35 UMOL/L TO 40 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21912952 ↗
• MalfunctionMar 20, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 RESULTS FROM THE COBAS 8000 COBAS C 701 MODULE. THE INITIAL RESULT WAS 1.31 MG/DL. THE REPEAT RESULT FROM ANOTHER C701 ANALYZER WAS 0.82 MG/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652720 ↗
• MalfunctionAug 22, 2024High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE CREP2 (CREATININE) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 COBAS C 701 MODULE. ON (B)(6) 2024: THE INITIAL RESULT OF THE INITIAL PATIENT SAMPLE IN A LITHIUM HEPARINIZED TUBE WAS 63.57 MG/DL. ON (B)(6) 2024: THE REPEAT RESULT IN THE LITHIUM HEPARINIZED TUBE WAS 44.79 MG/DL. ON (B)(6) 2024: THE PATIENT COMPLAINED THAT THE RESULT FROM ANOTHER HOSPITAL WAS NORMAL. THE REPEAT RESULT OF THE INITIAL PATIENT SAMPLE IN A DRY TUBE WAS 8.39 MG/DL. THE SECOND REPEAT RESULT OF THE INITIAL PATIENT SAMPLE IN A DRY TUBE WAS 8.57 MG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20035301 ↗
• MalfunctionJul 5, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE CREP2 (CREATININE) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY AS IT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. THE REPORTER ALLEGED THE INITIAL RESULT FROM THE MODULE WAS LOW DUE TO AN INTERFERENCE WITH THE PATIENT'S MEDICATION. ON (B)(6) 2024: THE INITIAL RESULT OF THE INITIAL PATIENT SAMPLE FROM THE MODULE WAS 372 UMOL/L. THE FIRST REPEAT RESULT OF THE INITIAL PATIENT SAMPLE FROM A HITACHI ANALYZER USING A MACCURA REAGENT WAS 503 UMOL/L. THE SECOND REPEAT RESULT OF THE INITIAL PATIENT SAMPLE FROM ANOTHER FACILITY WAS 458.2 UMOL/L. THE REPEAT RESULTS WERE FROM ASSAYS WHICH ALSO USE AN ENZYMATIC LABORATORY METHOD. ON (B)(6) 2024: A NEW PATIENT SAMPLE WAS COLLECTED FROM THE PATIENT AFTER HIS MEDICATION OF 20ML OF ACETYLCYSTEINE (4G AND 8G INFUSION PUMP) WAS DISCONTINUED. THE INITIAL RESULT OF THE NEW PATIENT SAMPLE FROM THE MODULE WAS 540 UMOL/L. THE REPEAT RESULT OF THE NEW PATIENT SAMPLE USING THE MACCURA REAGENT WAS 548 UMOL/L. THE REPORTER DEEMED THESE RESULTS CONSISTENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19684263 ↗
• MalfunctionOct 13, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE CREATININE (CREP GEN.2) RESULT FROM THE COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS 9.7 MG/DL AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT HAD A NEW SAMPLE DRAWN AT ANOTHER FACILITY AND THE RESULT DID NOT MATCH. NO SPECIFIC DATA WAS PROVIDED. THE ORIGINAL SAMPLE WAS REPEATED AND THE RESULT WAS 0.6 MG/DL. THIS RESULT WAS BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17932058 ↗
• MalfunctionAug 29, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT URINE SAMPLE TESTED FOR CREP2 CREATININE PLUS VER.2 (CREP2) ON A COBAS 8000 C 702 MODULE. THE INITIAL RESULT FROM THE C702 MODULE WAS 155.58 MG/DL. THE SAME SAMPLE WAS ALSO SENT TO ANOTHER LABORATORY WHERE THE RESULT WAS 306.21 MG/DL. THE INITIAL RESULT FROM THE C702 MODULE WAS REPORTED OUTSIDE OF THE LABORATORY WHERE IT WAS QUESTIONED BY THE NURSE. THE CUSTOMER REPEATED THE SAMPLE TWICE ON THE C702 MODULE WITH RESULTS OF APPROXIMATELY 300 MG/DL. AN ALIQUOT FROM THE SAMPLE SENT TO THE OTHER LABORATORY WAS ALSO REPEATED TWICE WITH RESULTS OF APPROXIMATELY 300 MG/DL. THE RESULT OF 306.21 MG/DL AND THE REPEAT RESULTS OF APPROXIMATELY 300 MG/DL WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643784 ↗
• MalfunctionAug 18, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH CREP2 ON A COBAS 8000 C702 MODULE. THE PATIENT SAMPLE INITIALLY RESULTED IN A NEGATIVE VALUE FOR CREATININE ON THE C702 ANALYZER. AN INTERFERENCE WAS SUSPECTED AND A SERIAL DILUTION OF THE SAMPLE WAS PERFORMED USING WATER AND A CREATININE RESULT OF 30 UMOL/L WAS OBTAINED ON THE C702 ANALYZER. THE PATIENT SAMPLE WAS SENT TO ANOTHER LABORATORY WHERE AN UNKNOWN CREATININE JAFFE METHOD WAS USED, RESULTING IN A CREATININE VALUE OF 56 UMOL/L. THE CUSTOMER PERFORMED A POLYETHYLENE GLYCOL (PEG) PRECIPITATION OF THE SAMPLE AND REPEATED ON THE C702 ANALYZER AND THE CREATININE RESULT WAS 50 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17577898 ↗
• MalfunctionAug 2, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CREP2 (CREATININE) ON A COBAS 8000 C702 MODULE. THE SAMPLE INITIALLY RESULTED IN A CREATININE VALUE OF 72 UMOL/L. THE SAMPLE WAS THEN REPEATED USING THE CREATININE JAFFE METHOD AND THE CREATININE VALUE WAS 169 UMOL/L. THE SAMPLE WAS THEN DILUTED 1:3 AND REPEATED USING THE ORIGINAL CREP2 METHOD AND THE CREATININE VALUE WAS 105 UMOL/L ACCOMPANIED BY A DATA FLAG. THE 169 UMOL/L VALUE WAS REPORTED TO THE PATIENT BECAUSE IT AGREED WITH THE PATIENT'S CLINICAL PICTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17439759 ↗
• MalfunctionMay 10, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH THE CREP2 (CREATININE PLUS VER.2) ASSAY ON A COBAS 8000 C702 MODULE, SERIAL NUMBER (B)(6). THE FOLLOWING EXAMPLES OF DISCREPANT CREP2 RESULTS WERE PROVIDED BY THE CUSTOMER: PATIENT SAMPLE 1: THE SAMPLE INITIALLY RESULTED IN A CREP2 VALUE OF 259 UMOL/L AND REPEATED AS 179 UMOL/L ON THE SECOND INSTRUMENT LINE, C702 MODULE SERIAL NUMBER (B)(6). PATIENT SAMPLE 2: THE SAMPLE INITIALLY RESULTED IN A CREP2 VALUE OF 60 UMOL/L. THE SAMPLE WAS REPEATED THREE TIMES ON THE SECOND INSTRUMENT LINE, C702 MODULE SERIAL NUMBER (B)(6), RESULTING IN VALUES OF 42 UMOL/L, 45 UMOL/L AND 111 UMOL/L. IT WAS ASKED BUT IT IS UNCLEAR WHICH RESULTS ARE CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16904064 ↗
• MalfunctionMay 8, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH THE CREP2 (CREATININE PLUS VER.2) ASSAY ON A COBAS 8000 C702 MODULE, SERIAL NUMBER (B)(6). THE FOLLOWING EXAMPLES OF DISCREPANT CREP2 RESULTS WERE PROVIDED BY THE CUSTOMER: PATIENT SAMPLE 1: THE SAMPLE INITIALLY RESULTED IN A CREP2 VALUE OF 259 UMOL/L AND REPEATED AS 179 UMOL/L ON A SECOND INSTRUMENT LINE. PATIENT SAMPLE 2: THE SAMPLE INITIALLY RESULTED IN A CREP2 VALUE OF 60 UMOL/L. THE SAMPLE WAS REPEATED THREE TIMES ON A SECOND INSTRUMENT LINE RESULTING IN VALUES OF 42 UMOL/L, 45 UMOL/L, AND 111 UMOL/L. IT WAS ASKED BUT IT IS UNCLEAR WHICH RESULTS ARE CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16888649 ↗
• MalfunctionApr 11, 2023High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE CREP2 (CREATININE PLUS VER.2) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 COBAS C 701 MODULE WITH SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT SAMPLE WAS RERUN ON ANOTHER MODULE. THE INITIAL RESULT FROM THE MODULE WAS 307 MOL/L. THE REPEAT RESULT FROM THE OTHER MODULE WAS 91.4 MOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16712043 ↗
• MalfunctionMar 2, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREP2 CREATININE PLUS VER.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C702 MODULE. ON (B)(6) 2023, THE INITIAL CREP2 RESULT WAS 4.05 MG/DL. THE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR QUESTIONED THE RESULT AS IT DIDN'T THE PATIENT'S CLINICAL PICTURE AND THE SAMPLE WAS REPEATED. ON (B)(6) 2023, THE SAMPLE WAS REPEATED AND THE RESULT WAS 0.96 MG/DL. THE REAGENT LOT NUMBER IS 657574 AND THE EXPIRATION DATE IS 31-MAY-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16472235 ↗
• MalfunctionJan 20, 2023Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR MULTIPLE SAMPLES FROM THE SAME PATIENT TESTED WITH THE CREP2 (CREATININE PLUS VER.2) ASSAY ON A COBAS 8000 C702 MODULE, SERIAL NUMBER (B)(4). AN INTERFERENCE AFFECTING THE ROCHE RESULTS IS SUSPECTED. (B)(6) 2022. VENIPUNCTURE TIME OF PATIENT SAMPLE 1: 18:00. PATIENT SAMPLE 1 INITIALLY RESULTED IN A CREP2 VALUE OF < -42 UMOL/L, ACCOMPANIED BY A DATA FLAG, AND REPEATED AS < -28 UMOL/L, ACCOMPANIED BY A DATA FLAG. VENIPUNCTURE TIME OF PATIENT SAMPLE 2: 20:06. PATIENT SAMPLE 2 INITIALLY RESULTED IN A CREP2 VALUE OF < -25 UMOL/L, ACCOMPANIED BY A DATA FLAG AND REPEATED AS < -35 UMOL/L ACCOMPANIED BY A DATA FLAG. (B)(6) 2022, A SAMPLE OF THE PATIENT WAS MEASURED WITH A 1:2, 1:5, AND 1:10 DILUTION, RESULTING IN CREP2 VALUES OF 73 UMOL/L, 14 UMOL/L AND 2 UMOL/L. IT WAS ASKED BUT IT IS UNKNOWN IF THE RESULTS ARE FROM A DIFFERENT SAMPLE COLLECTED FROM THE PATIENT OR IF THESE WERE REPEATS FROM ANY OF THE OTHER SAMPLES. (B)(6) 2022, PATIENT SAMPLE 3 RESULTED IN A CREP2 VALUE OF < -53 UMOL/L, ACCOMPANIED BY A DATA FLAG. PATIENT SAMPLE 3 WAS REPEATED IN A DIFFERENT LABORATORY ON A COBAS C 502 ANALYZER, RESULTING IN A CREP2 VALUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16214148 ↗
• MalfunctionOct 27, 2022Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE CREATININE PLUS VER.2 RESULT FOR 1 PATIENT SAMPLE ON A COBAS 8000 C701 MODULE. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT. A NEW SAMPLE WAS COLLECTED FROM THE PATIENT. THE REPORTER IS LOOKING FOR A MEDICAL EXPLANATION FOR SUCH A DECREASE IN THE RESULTS. IT WAS ALLEGED THAT THE DIFFERENCE IN RESULTS BETWEEN THE TWO SAMPLES WAS NOT POSSIBLE DUE TO THE PATIENT¿S CONDITION. ON (B)(6) 2022 , THE INITIAL RESULT OF THE INITIAL SAMPLE WAS 134 UMOL/L. ON (B)(6) 2022 , THE RESULT OF THE NEW SAMPLE WAS 77 UMOL/L. THE C701 MODULE SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15680166 ↗
• MalfunctionAug 12, 2021Imprecision; Incorrect, Inadequate or Imprecise Result or Readings; Imprecision

  THE INITIAL REPORTER RECEIVED QUESTIONABLE CREP2 CREATININE PLUS VER.2 RESULTS FOR MULTIPLE PATIENT SAMPLES WITH THE COBAS 8000 COBAS C 701 MODULE SERIAL NUMBER (B)(4) BETWEEN (B)(6) 2021. THE REPORTER STATED THE CALIBRATION LOOKED DIFFERENT THAN OTHER HISTORICAL CALIBRATIONS BUT WAS ACCEPTABLE AND QC WAS IN RANGE. UPON PERFORMING QC AGAIN, THE REPORTER NOTICED A SHIFT AND DECIDED TO REPEAT A COUPLE OF PATIENT SAMPLES AND THE RESULTS WERE NOT IN AGREEMENT. THE REPORTER THEN REPLACED THE REAGENT PACK, RECALIBRATED AND THE CALIBRATION WAS TYPICAL OF WHAT WAS OBSERVED IN THE PAST. THE REPORTER THEN REPEATED ALL SAMPLES TESTED BETWEEN (B)(6) 2021. THE FOLLOWING ARE EXAMPLES OF QUESTIONABLE RESULTS FOR 3 PATIENT SAMPLES: SAMPLE ID (B)(6). THE INITIAL RESULT WAS 0.84 MG/DL. THE REPEATED RESULT WAS 1.06 MG/DL. SAMPLE ID (B)(6). THE INITIAL RESULT WAS 0.91 MG/DL. THE REPEATED RESULT WAS 1.10 MG/DL. SAMPLE ID (B)(6). THE INITIAL RESULT WAS 0.83 MG/DL. THE REPEATED RESULT WAS 1.03 MG/DL. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEATED RESULTS WERE DEEMED CORRECT AND CORRECTED REPORTS WERE ISSUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12315760 ↗
• MalfunctionNov 27, 2019Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CREP2 CREATININE PLUS VER.2 ON AN UNKNOWN ROCHE CLINICAL CHEMISTRY ANALYZER. THE PATIENT SAMPLE WAS COLLECTED FROM A CENTRAL VENOUS CATHETER WITH THREE LINES. THE SAMPLE WAS COLLECTED FROM ONE LINE, WHILE DRUGS WERE ADMINISTERED TO THE PATIENT THROUGH THE OTHER TWO LINES. THE PATIENT WAS RECEIVING A DOPAMINE INFUSION THROUGH THE CENTRAL VENOUS CATHETER. THE CUSTOMER ALLEGES THE DOPAMINE MEDICATION INTERFERED WITH THE ROCHE CREATININE MEASUREMENT. A FIRST SAMPLE WAS COLLECTED FROM THE PATIENT AND THIS RESULTED WITH A CREATININE VALUE OF 34 UMOL/L WHEN TESTED ON THE ROCHE SYSTEM. THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. A SECOND SAMPLE WAS COLLECTED FROM THE PATIENT AND TESTED FOR CREATININE ON AN ABL ANALYZER, RESULTING WITH A VALUE OF 133 UMOL/L. DUE TO THE DIFFERENCE IN VALUES OF THE TWO SAMPLES, THE MEDICAL PERSONNEL QUESTIONED THE VALUE OF 34 UMOL/L MEASURED ON THE ROCHE SYSTEM. THE FIRST SAMPLE WAS REPEATED ON THE ROCHE SYSTEM AND THE REPEAT VALUE MATCHED THE INITIAL RESULT. THE FIRST SAMPLE WAS ALSO REPEATED ON THE ABL SYSTEM, RESULTING WITH A VALUE OF 140 UMOL/L. THE MODE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9384228 ↗
• MalfunctionApr 24, 2019Non Reproducible Results; Non Reproducible Results

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS. ERRONEOUS NON-REPRODUCIBLE RESULTS WERE GENERATED BY TWO COBAS 8000 C 702 MODULES. THE EVENTS INVOLVED A TOTAL OF 25 PATIENTS WITH THE FOLLOWING: 25 ERRONEOUS RESULTS FOR CREP2 CREATININE PLUS VER.2.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8544219 ↗
• MalfunctionOct 4, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER QUESTIONED RESULTS FOR 1 PATIENT TESTED FOR CREP2 CREATININE PLUS VER.2 (CREP2) ON A COBAS 8000 C (701) MODULE. THE PATIENT WAS INITIALLY DRAWN ON (B)(6) 2018 AND 2 SAMPLE TUBES OBTAINED. THE INITIAL CREP2 RESULT FROM 1 SAMPLE TUBE WAS 80 UMOL/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2018 A NEW SAMPLE WAS DRAWN AND 2 SAMPLE TUBES WERE OBTAINED. ONE TUBE WAS TESTED WITH A CREP2 RESULT OF 51 UMOL/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2018 THE CUSTOMER REPEATED BOTH SAMPLE TUBES FROM (B)(6) 2018 AND THE RESULTS WERE BOTH 80.5 UMOL/L. THE CUSTOMER THEN REPEATED BOTH SAMPLE TUBES FROM (B)(6) 2018 AND THE RESULTS WERE BOTH 51.0 UMOL/L. BASED ON THE PATIENT'S HISTORY, THE RESULTS OF 51 UMOL/L WERE BELIEVED TO BE CORRECT. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE C701 MODULE SERIAL NUMBER WAS (B)(4). IT WAS NOTED THAT THE PATIENT IS TAKING HYDROXYCHLOROQUINE. THE PATIENT IS TAKING IT TWICE DAILY BY MOUTH, ONCE IN THE MORNING AND ONCE IN THE EVENING. HYDROXYCHLOROQUINE HAS PEAK BLOOD LEVELS WITHIN 1-2 HOURS OF INGESTION. THE SAMPLE TUBES FROM (B)(6) 2018 WERE OBTAINED AT 12:59 P.M. THIS WOULD HAVE BEEN AFTER T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7933452 ↗
• MalfunctionSep 27, 2018Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CREP2 CREATININE PLUS VER.2 ON A COBAS 8000 C 702 MODULE. THE RESULTS DID NOT CORRESPOND TO THE CLINICAL PICTURE OF THE PATIENT. THE SAMPLE WAS INITIALLY TESTED ON ANOTHER C 702 ANALYZER, RESULTING WITH A CREP2 VALUE OF -4 UMOL/L. THE SAMPLE WAS REPEATED ON THE COMPLAINED C 702 ANALYZER, RESULTING WITH A VALUE OF 2 UMOL/L. THE SAMPLE WAS REPEATED ON THE COMPLAINED C 702 ANALYZER, RESULTING AS 3 UMOL/L. THE RESULTS WERE REPORTED TO THE DOCTOR WHO DID NOT BELIEVE THE RESULTS FIT THE PATIENT'S CLINICAL PICTURE. THE PATIENT NORMALLY HAS CREP2 VALUES OF 35 TO 45 UMOL/L. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE C 702 ANALYZER SERIAL NUMBER IS (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7915337 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K024098. One submission often covers many models, so check the product and lot details in each record.

• Z-1125-2019 · Dec 14, 2018 · Terminated
  cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 05401470190; b)Triglycerides Catalog Number: 04657594190 - Pro
• Z-0008-2009 · Jun 11, 2008 · Terminated
  Roche Diagnostics CREP2, Creatinine Plus Ver. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03263991190. An in-vitro diagnostic reagent system intended