Creatinine plus ver2 3263991190Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04015630919215), received between Aug 9, 2018 and Dec 23, 2025 — classified as 25 malfunctions.

The most frequently reported specific device problem is “High Test Results” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionDec 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF A QUESTIONABLE CREATININE PLUS VER.2 RESULT FROM THE COBAS INTEGRA 400 PLUS FOR TWO PATIENTS. PATIENT 1'S INITIAL RESULT WAS 2.02 MG/DL, AND THE REPEAT RESULT WAS 1.0 MG/DL. PATIENT 2'S INITIAL RESULT ON (B)(6) 2025 WAS 1.21 MG/DL, ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS 0.59 MGDL. THE CUSTOMER ALSO PROVIDED QUESTIONABLE URIC ACID VER.2 RESULTS FOR ONE PATIENT AND CALCIUM GEN.2 RESULTS FOR ONE PATIENT. THIS MEDWATCH WILL COVER THE CREATININE PLUS VER.2 ASSAY. SEE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE URIC ACID VER.2 ASSAY. SEE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE CALCIUM GEN.2 ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876623 ↗
• MalfunctionDec 15, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 COBAS C 502 MODULE. A SERUM SAMPLE WAS COLLECTED FROM A PATIENT UNDERGOING ELTROMBOPAG THERAPY. THE SAMPLE WAS COFFEE-BROWN IN COLOR. THE INITIAL RESULT WAS APPROXIMATELY 120 UMOL/L. THE CUSTOMER ALLEGED THAT THE C 502 ANALYZER FAILED TO DETECT THE SAMPLE DISCOLORATION, AND THE CLINIC WAS ADVISED TO REQUEST CREATININE RESULTS USING A BLOOD GAS ANALYZER. THE SAMPLE WAS REPEATED ON AN UNKNOWN BLOOD GAS ANALYZER, RESULTING IN A CREATININE VALUE OF APPROXIMATELY 160 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23801192 ↗
• MalfunctionNov 11, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C501 MODULE THE INITIAL RESULT WAS 15.83 MG/DL. THE REPEAT RESULT WAS 0.92 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526040 ↗
• MalfunctionJun 3, 2025High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH CREATININE PLUS VER.2 (CREP2) ASSAY ON A COBAS 6000 C501 MODULE. INITIAL RESULT: 425.4 ¿MOL/L. THE CUSTOMER QUESTIONED THE INITIAL RESULT AND REPEATED THE SAMPLE. REPEAT RESULT: 74.3 ¿MOL/L. THE REPEAT RESULT OF 74.3 ¿MOL/L WAS DEEMED TO BE CORRECT. REPORTEDLY, AN AMENDED REPORT WITH THE CORRECT RESULT WAS ISSUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131213 ↗
• MalfunctionNov 26, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE COBAS INTEGRA CREATININE PLUS VER.2 ASSAY RESULTS FOR 1 PATIENT ON A COBAS INTEGRA 400 PLUS ANALYZER. THE INITIAL RESULT WAS 2.23 MG/DL USING A LITHIUM HEPARIN PLASMA TUBE. THE REPEATED RESULT WAS 0.46 MG/DL USING A PLASMA ETHYLENEDIAMINETETRAACETIC ACID (EDTA) TUBE. THE SAMPLE WAS REPEATED AND THE RESULT WAS 2.13 MG/DL USING A LITHIUM HEPARIN PLASMA TUBE AND 0.45 MG/DL USING A PLASMA ETHYLENEDIAMINETETRAACETIC ACID (EDTA) TUBE. A NEW SAMPLE WAS TESTED AND THE PLAIN SERUM TUBE RESULT WAS 0.44 MG/DL. IT WAS REPORTED THAT THE RESULT FROM THE PLASMA EDTA TUBE WAS ALMOST THE SAME BUT A NUMERICAL VALUE WAS NOT PROVIDED. THE CUSTOMER CONSIDERED THE RESULT FROM THE PLAIN SERUM TUBE (0.44 MG/DL) AND THE EDTA TUBE RESULTS (0.46 MG/DL AND 0.45 MG/DL) TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20788810 ↗
• MalfunctionNov 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH CREATININE PLUS VER.2 (CREP2) ASSAY ON A COBAS INTEGRA 400 PLUS ANALYZER. PATIENT 1: INITIAL RESULT: 361.9 MOL/L. REPEAT RESULT: 174.3 MOL/L. PATIENT 2 WAS TESTED ON (B)(6) 2024: INITIAL RESULT: 245.9 MOL/L. 1ST REPEAT RESULT: 60 MOL/L. 2ND REPEAT RESULT: 59 MOL/L. THE PHYSICIAN QUESTIONED THE INITIAL RESULTS AS BOTH PATIENTS WERE NOT RENAL PATIENTS AND REQUESTED THE SAMPLE TO BE REPEATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622632 ↗
• MalfunctionOct 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ASSAY RESULTS FROM MULTIPLE PATIENT SAMPLES TESTED ON THE COBAS 6000 C 501 (UL) V. THE REPORTER PROVIDED EXAMPLES OF QUESTIONABLE ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (ASTL) AND CREP GEN.2 (CREP2) RESULTS. THIS MEDWATCH IS FOR THE CREATININE PLUS VER.2 ASSAY PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ASPARTATE AMINOTRANSFERASE ASSAY. THE INITIAL RESULT FROM THE ANALYZER WAS 0.23 NG/ML. THE REPEAT RESULT FROM ANOTHER ANALYZER WAS 1.49 MG/DL. THE REPEAT RESULT WAS DEEMED CORRECT. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT SAMPLE WAS RERUN BECAUSE OF MULTIPLE INVALIDATING FLAGS FOR OTHER ASSAYS. THE REPORTER SAID THEY ACCIDENTALLY RAN A WHOLE BLOOD PATIENT SAMPLE FOR A COMPLETE METABOLIC PANEL (CMP) ASSAY BEFORE THE REPORTED PATIENT SAMPLE WAS RUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20482587 ↗
• MalfunctionAug 14, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE COBAS INTEGRA CREATININE PLUS VER.2 ASSAY RESULTS FOR 3 PATIENT SAMPLES ON A COBAS INTEGRA 400 PLUS ANALYZER. PATIENT 1 THE INITIAL RESULT WAS 1.73 MG/DL. THE RESULT WAS REPORTED OUTSIDE THE LABORATORY. ANOTHER SAMPLE FROM THE PATIENT WAS TESTED AT ANOTHER LABORATORY. DUE TO THE DISCREPANCY BETWEEN THE RESULTS, THE INITIAL SAMPLE WAS RETESTED. ON (B)(6) 2024 THE REPEATED RESULT WAS 0.9 MG/DL. PATIENT 2: ON (B)(6) 2024 THE INITIAL RESULT WAS 1.48 MG/DL. ON (B)(6) 2024 THE REPEATED RESULT WAS 0.9 MG/DL. PATIENT 3: ON (B)(6) 2024 THE INITIAL RESULT WAS 1.25 MG/DL AND THE REPEATED RESULT WAS 0.73 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19984299 ↗
• MalfunctionJun 3, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE HIGH COBAS INTEGRA CREATININE PLUS VER.2 ASSAY RESULTS FROM THE COBAS 6000 C 501 ANALYZER. THE INITIAL RESULT WAS 1.24 MG/DL AND THE REPEAT WAS 0.94 MG/DL. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19453704 ↗
• MalfunctionMar 29, 2024Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS SAMPLES TESTED WITH CREP GEN.2 (CREP2) ASSAY ON A COBAS INTEGRA 400 PLUS ANALYZER. SAMPLE 1: INITIAL RESULT: 141.1 UMOL/L. REPEAT RESULT: 73.1 UMOL/L. SAMPLE 2: INITIAL RESULT: 189.7 UMOL/L. REPEAT RESULT: 80 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19004817 ↗
• MalfunctionMar 26, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE (CREP GEN.2) RESULTS FROM THE COBAS 8000 COBAS C 502 MODULE. THE PATIENT WAS A TRANSPLANT PATIENT AND WAS REGULARLY CHECKED BY HIS NEPHROLOGIST WHO CLAIMED THE RESULTS WERE TOO HIGH AND DID NOT FIT THE PATIENT HISTORY AND STATUS. THE CUSTOMER QUESTIONED IF THERE WAS AN INTERFERENCE WITH THE PATIENT'S MEDICATIONS. THE CREATININE RESULT USING THE JAFFE METHOD IN ANOTHER LABORATORY WAS <100 ¿MOL/L. THE CREATININE RESULTS USING THE ENZYMATIC METHOD WERE 223 ¿MOL/L AND 177 UMOL/L. THE RESULTS WERE OBTAINED WITH DIFFERENT SAMPLES FROM DIFFERENT VENIPUNCTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18978772 ↗
• MalfunctionFeb 20, 2024Unable to Obtain Readings; Unable to Obtain Readings

  THE INITIAL REPORTER QUESTIONED RESULTS FOR 1 PATIENT TESTED FOR COBAS INTEGRA CREATININE PLUS VER.2 ASSAY (CREP2) ON A COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS [-] 2.94 MG/DL WITH A DATA FLAG. THE REPEAT RESULT FROM A DIFFERENT ANALYZER WAS [-] 3.28 MG/DL WITH A DATA FLAG. THE RESULT IN DECREASED MODE WAS 4.39 MG/DL. A NEW SERUM SAMPLE WAS OBTAINED AND THE INITIAL RESULT WAS [-] 2.08 MG/DL WITH A DATA FLAG. THE PLASMA K2 EDTA RESULT WAS [-] 1.76 MG/DL WITH A DATA FLAG. THE CALCULATED RESULT FROM A 1:2 DILUTION WAS 3 MG/DL. THE RESULT FROM ANOTHER LABORATORY USING CREATININE JAFFE WAS 1.17 MG/DL. THE RESULT FROM ANOTHER LABORATORY USING A COMPETITOR METHOD WAS 1.34 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18741975 ↗
• MalfunctionOct 18, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREP2 CREATININE PLUS VER.2 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS INTEGRA 400 PLUS. FOR SAMPLE 1, THE INITIAL CREP2 RESULT WAS 190.6 UMOL/L. THE REPEAT RESULT WAS 67.5 UMOL/L. FOR SAMPLE 2, THE INITIAL CREP2 RESULT WAS 101.7 UMOL/L. THE FIRST REPEAT RESULT WAS 185.7 UMOL/L AND THE SECOND REPEAT RESULT WAS 101.7 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17957104 ↗
• MalfunctionMay 23, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER QUESTIONED LOW RESULTS FOR 1 PATIENT SAMPLE TESTED FOR CREP2 CREATININE PLUS VER.2 (CREP2) ON A COBAS 6000 C (501) MODULE. THE INITIAL RESULT WAS 69 UMOL/L. THE SAMPLE WAS REPEATED FROM THE SAME TUBE WITH A RESULT OF 69 UMOL/L. A NEW SAMPLE WAS OBTAINED "A FEW DAYS LATER" AND TESTED IN ANOTHER LABORATORY USING AN UNKNOWN METHOD AND THE RESULT WAS CONSISTENT WITH THE PATIENT¿S PREVIOUS CREP2 RESULTS BETWEEN 262 UMOL/L AND 288 UMOL/L. THE SPECIFIC RESULT WAS NOT PROVIDED. THE CUSTOMER QUESTIONS IF ANY OF THE PATIENT¿S MEDICATIONS COULD BE INTERFERING WITH THE CREP2 TEST. THE C501 MODULE SERIAL NUMBER WAS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16987415 ↗
• MalfunctionMar 31, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE CREP2 (CREATININE PLUS VER.2) ASSAY ON A COBAS 6000 C 501 MODULE, SERIAL NUMBER (B)(4). THE SAMPLE INITIALLY RESULTED IN A CREP2 VALUE OF 511 UMOL/L. A NEW SAMPLE DRAW OF THE PATIENT, TESTED IN A DIFFERENT LABORATORY, RESULTED IN A CREP2 VALUE OF 72 UMOL/L. THE INITIAL SAMPLE WAS THEN REPEATED, RESULTING IN A CREP2 VALUE OF 72 UMOL/L. A SECOND NEW SAMPLE DRAW OF THE PATIENT, RESULTED IN A CREP2 VALUE OF 65 UMOL/L. THE INITIAL QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16659561 ↗
• MalfunctionMar 16, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH CREP2 CREATININE PLUS VER.2 ON A COBAS 6000 C (501) MODULE (SERIAL NUMBER (B)(4)). IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE INITIALLY RESULTED IN A CREATININE VALUE OF 199.7 UMOL/L WHEN TESTED ON A SIEMENS ANALYZER. THE SAMPLE WAS REPEATED WITH THE ROCHE CREATININE METHOD ON THE C 501 ANALYZER, RESULTING IN A VALUE OF 99 UMOL/L. THE SECOND SAMPLE INITIALLY RESULTED IN A CREATININE VALUE OF 205.0 UMOL/L WHEN TESTED ON A SIEMENS ANALYZER. THE SAMPLE WAS REPEATED WITH THE ROCHE CREATININE METHOD ON THE C 501 ANALYZER, RESULTING IN A VALUE OF 99 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16555782 ↗
• MalfunctionMar 10, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE CREP2 (CREATININE PLUS VER. 2) ASSAY ON A COBAS 6000 C 501 MODULE, SERIAL NUMBER (B)(4). THE SAMPLE INITIALLY RESULTED IN AN INVALID CREP2 RESULT, ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS RE-CENTRIFUGED AND THEN REPEATED, RESULTING IN A CREP2 VALUE OF 0.92 MG/DL. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS REPEATED A SECOND TIME, RESULTING IN A CREP2 VALUE OF 1.58 MG/DL. THIS RESULT FITS THE CLINICAL PICTURE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16523478 ↗
• MalfunctionFeb 28, 2023High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR COBAS INTEGRA CREATININE PLUS VER.2 ASSAY (CREP2) ON A COBAS INTEGRA 400 PLUS. THE INITIAL RESULT WAS 231 UMOL/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE IT WAS QUESTIONED BY THE DOCTOR. THE REPEAT RESULT WAS 84.4 UMOL/L. THE INTEGRA 400 PLUS ANALYZER SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16454460 ↗
• MalfunctionDec 8, 2022Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CREP2 CREATININE PLUS VER.2 ON A COBAS 8000 C 502 MODULE. THE SAMPLE WAS INITIALLY PROCESSED ON A COBAS P 612 PRE-ANALYTICS SYSTEM PRIOR TO TESTING ON THE C 502 MODULE. THE PATIENT SAMPLE INITIALLY RESULTED IN A CREATININE VALUE OF 215.8 UMOL/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT WAS ADMITTED BASED ON THE VALUE. A CREATININE MEASUREMENT PERFORMED ON THE PATIENT ON (B)(6) 2022 WAS LOWER. THE COMPLAINED SAMPLE WAS THEN REPEATED ON A SECOND ANALYZER, RESULTING IN A CREATININE VALUE OF 77.0 UMOL/L. THE SAMPLE WAS ALSO REPEATED ON A THIRD ANALYZER, RESULTING IN A VALUE OF 81.8 UMOL/L. THE SAMPLE WAS THEN REPEATED ON THE COMPLAINED ANALYZER, RESULTING IN A VALUE OF 74.8 UMOL/L. THE CREATININE REAGENT LOT NUMBER WAS 663665, WITH AN EXPIRATION DATE OF 30-JUN-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15938825 ↗
• MalfunctionNov 28, 2022Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH CREP2 (CREATININE PLUS VER.2) ON A COBAS INTEGRA 400 PLUS ANALYZER. PATIENT 1, MEASURED ON (B)(6) 2022: THE SAMPLE INITIALLY RESULTED IN A CREP2 VALUE OF 100 ¿MOL/L. THE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND DID NOT MATCH THE PATIENT'S HISTORY. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 51 ¿MOL/L. PATIENT 2, MEASURED ON (B)(6) 2022: THE SAMPLE INITIALLY RESULTED IN A CREP2 VALUE OF 131 ¿MOL/L, ACCOMPANIED BY A DATA FLAG. THE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND DID NOT MATCH THE PATIENT'S HISTORY. THE SAMPLE WAS REPEATED TWO TIMES, RESULTING IN VALUES OF 69 ¿MOL/L AND 68 ¿MOL/L. THE CREP2 REAGENT LOT WAS 635960 WITH AN EXPIRATION DATE OF 31-JAN-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15868216 ↗
• MalfunctionMay 3, 2022High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE CREP2 CREATININE PLUS VER.2 RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS 6000 C 501 MODULE WITH SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2022, THE INITIAL RESULT WAS 58.3 MG/DL. THE FIRST REPEAT RESULT WAS 57. 8 MG/DL WITH A DATA FLAG. THE FIRST REPEAT RESULT WAS FROM AN AUTOMATIC RERUN BECAUSE OF A MIDDLEWARE RULE. THE PATIENT WAS SENT TO THE EMERGENCY ROOM (ER) BECAUSE THEY THOUGHT HE HAD RENAL INSUFFICIENCY. AT THE ER, HIS CREATININE RESULT WAS REPORTED TO BE AT A LOW LEVEL. ON (B)(6) 2022, THE REPORTER RERAN THE INITIAL SAMPLE. THE SECOND REPEAT RESULT WAS 48.6 MG/DL. THE REPORTER ALSO RERAN THE SAME SAMPLE COLLECTED IN A TUBE WITH A GEL SEPARATOR. THE THIRD REPEAT RESULT WAS 8.6 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14268526 ↗
• MalfunctionApr 24, 2019High Test Results; High Test Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. ERRONEOUS HIGH RESULTS WERE GENERATED BY THE COBAS 6000 C (501) MODULE. THE EVENT INVOLVED A TOTAL OF 1 PATIENT WITH THE FOLLOWING: ONE ERRONEOUS RESULT FOR CREJ2 CREATININE JAFFÉ GEN.2.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8544214 ↗
• MalfunctionSep 7, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR FOUR PATIENT SAMPLES TESTED FOR CREP2 CREATININE PLUS VER.2 ON A COBAS 6000 C (501) MODULE. THE CUSTOMER STATED THAT THE ANALYZER SWITCHED FROM USING THEIR CURRENT CREP2 REAGENT PACK TO USING A STANDBY PACK. THE AFFECTED SAMPLES APPEARED TO BE TESTED USING THE STANDBY PACK AND THAT THERE WERE NO ISSUES WITH SAMPLE RESULTS MEASURED FROM THE CURRENT PACK. THE THIRD PATIENT SAMPLE ALSO HAD AN ERRONEOUS RESULT FOR ISE INDIRECT (B)(6) FOR GEN.2. THIS MEDWATCH WILL APPLY ONLY TO THE CREP2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO (B)(6). ALL ERRONEOUS INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE FIRST PATIENT SAMPLE INITIALLY RESULTED WITH A CREP2 VALUE OF 3.29 MG/DL. WHEN REPEATED ON (B)(6) 2018, THE SAMPLE RESULTED WITH A CREP2 VALUE OF 0.74 MG/DL. THE SECOND PATIENT SAMPLE, FROM A (B)(6) YEAR OLD FEMALE PATIENT, INITIALLY RESULTED WITH A CREP2 VALUE OF 5.90 MG/DL. WHEN REPEATED ON (B)(6) 2018, THE SAMPLE RESULTED WITH A CREP2 VALUE OF 0.91 MG/DL. THE THIRD PATIENT SAMPLE, FROM A (B)(6) YEAR OLD FEMALE PATIENT,

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7854983 ↗
• MalfunctionAug 29, 2018High Test Results; High Test Results

  THE CUSTOMER ORIGINALLY COMPLAINED ABOUT QUESTIONABLE CREP2 CREATININE PLUS VER.2 TESTED ON BOTH A COBAS 6000 C (501) MODULE AND A COBAS 8000 (UNSPECIFIED MODULE) COMPARED TO AN ABBOTT SYSTEM. FROM THE DATA PROVIDED, A REPORTABLE MALFUNCTION WAS PROVIDED FOR CREP2, ASTLP ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION, ALTLP ALANINE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION, AND GGT-2 -GLUTAMYLTRANSFERASE VER.2 STANDARDIZED AGAINST IFCC / SZASZ. THIS MEDWATCH WILL COVER CREP2. PLEASE REFER TO THE MEDWATCH WITH (B)(6) FOR INFORMATION ON ASTLP. PLEASE REFER TO THE MEDWATCH WITH (B)(6) FOR INFORMATION ON GGT-2. PLEASE REFER TO THE MEDWATCH WITH (B)(6) FOR INFORMATION ON ALTLP. THE ERRONEOUS RESULTS WERE RELEASED OUTSIDE OF THE LABORATORY. THE PATIENT WAS SENT TO THE HOSPITAL DUE THE INITIAL HIGH CREP2 RESULT, BUT THERE WAS NO ALLEGATION THAT THE PATIENT WAS ADVERSELY AFFECTED. THE COBAS C501 SERIAL (B)(4). THE CUSTOMER DID NOT PROVIDE ANY SPECIFIC INFORMATION ON THE COBAS 8000 SYSTEM. A PRELIMINARY ASSESSMENT OF THE CASE STATED THAT BASED ON PREVIOUS ELECTROPHORESIS TESTING OF THE PATIENT, THE PATIENT IS BELIEVED TO HAVE AN INTERFERI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7827859 ↗
• MalfunctionAug 9, 2018High Test Results; High Test Results

  THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR CREP2 CREATININE PLUS VER.2 ON A COBAS 6000 C (501) MODULE - C501. THE CUSTOMER STATED THAT THERE WERE NO CLOTS OR FIBRIN IN THE SAMPLE. THE SAMPLE INITIALLY RESULTED WITH A CREP2 VALUE OF 3.49 MG/DL AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED, RESULTING AS 0.93 MG/DL. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE CREP2 REAGENT LOT NUMBER WAS 32825201, WITH AN EXPIRATION DATE OF 31-DEC-2018. A GENERAL REAGENT ISSUE COULD BE RULED OUT SINCE CALIBRATION AND CONTROLS ARE ACCEPTABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7766976 ↗

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 - Product
• 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