Elecsys Troponin T Gen 5 08469865160Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 07613336158951), received between Jan 26, 2023 and Mar 30, 2026 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (19 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.

• MalfunctionMar 30, 2026Low Test Results; Output Problem; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH ELECSYS TROPONIN T GEN 5 STAT ASSAY ON A COBAS E 411 ANALYZER (DISK SYSTEM). SAMPLE 1: INITIAL RESULT: 9.7 NG/L. REPEAT RESULT: 18.4 NG/L. SAMPLE 2: INITIAL RESULT: 15.8 NG/L. REPEAT RESULTS: 65.1 NG/L AND 64.7 NG/L. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24730967 ↗
• MalfunctionMar 26, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T GEN 5 STAT RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS 306 NG/L. THE CUSTOMER QUESTIONED THE HIGH RESULT WHICH PROMPTED THEM TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED ON ANOTHER E601 ANALYZER AND THE RESULT WAS 12.85 NG/L. THE REPEAT RESULT WAS DEEMED CORRECT. THE PATIENT HAD A NEW SAMPLE COLLECTED AND TESTED ON BOTH E601 ANALYZERS AND THE RESULTS WERE BOTH WITHIN NORMAL RANGE. THE EXACT RESULTS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701960 ↗
• MalfunctionFeb 11, 2026High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED THREE QUESTIONABLE ELECSYS TROPONIN T GEN 5 STAT RESULTS FROM THE COBAS E 411 ANALYZER (RACK SYSTEM) FOR TWO PATIENTS. PATIENT SAMPLE 1: THE INITIAL RESULT WAS 10 NG/L. THE REPEAT RESULT WAS <6 NG/L. PATIENT SAMPLE 2: THE INITIAL RESULT WAS 10 NG/L. THE REPEAT RESULT WAS <6 NG/L. PATIENT SAMPLE 3: THE INITIAL RESULT WAS 19 NG/L. THE REPEAT RESULT WAS 13 NG/L. THE QC BECAME OUT OF RANGE, PROMPTING THE RERUN. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312536 ↗
• MalfunctionJan 26, 2026Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TROPONIN T GEN 5 STAT ON A COBAS 6000 E601 MODULE. THE SAMPLE INITIALLY RESULTED IN A TROPONIN T VALUE OF 11.12 NG/L. THE PATIENT'S NURSE ASKED FOR A REPEAT OF THE SAMPLE SINCE THE VALUE DID NOT AGREE WITH THE PATIENT'S CLINICAL STATUS. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 115.2 NG/L WITH A DATA FLAG. THE REPEAT VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177349 ↗
• MalfunctionDec 30, 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 ELECSYS TROPONIN T GEN 5 STAT (TROPONIN T STAT) ON A COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS 65.88 NG/L. THE 1-HOUR SAMPLE PRODUCED A DATA FLAG ON THE E601 MODULE. A NUMERIC RESULT WAS NOT PROVIDED. THE 2-HOUR SAMPLE PRODUCED A DATA FLAG ON THE E601 MODULE. A NUMERIC RESULT WAS NOT PROVIDED. DUE TO THE INITIAL HIGH RESULT, THE ORIGINAL SAMPLE WAS REPEATED WITH A RESULT OF 7.11 NG/L. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921404 ↗
• MalfunctionDec 10, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TROPONIN T GEN 5 STAT ON A COBAS E411 RACK. A BASELINE SAMPLE COLLECTED FROM THE PATIENT RESULTED IN A TROPONIN T VALUE OF 424 NG/L. ONE HOUR LATER, A SECOND SAMPLE WAS COLLECTED FROM THE PATIENT AND TESTED, RESULTING IN A TROPONIN T VALUE OF 16.25 NG/L. SINCE THE VALUE WAS DIFFERENT FROM THE BASELINE VALUE, THE CUSTOMER DECIDED TO REPEAT THE SAMPLE. THIS SAMPLE WAS REPEATED, RESULTING IN A TROPONIN T VALUE OF 430 NG/L. THE SAMPLE WAS ALSO REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 433.3 NG/L. THE VALUE OF 433.3 NG/L WAS DEEMED CORRECT AND A CORRECTED REPORT WAS ISSUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769591 ↗
• MalfunctionSep 11, 2025Incorrect Measurement; High Readings; Low Readings; Incorrect Measurement; High Readings; Low Readings

  THE INITIAL REPORTER STATED THEY RECEIVE QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH ELECSYS TROPONIN T GEN 5 STAT ON A COBAS 6000 E601 MODULE. THE CUSTOMER PROVIDED AN EXAMPLE OF ONE PATIENT SAMPLE WITH DISCREPANT TROPONIN T RESULTS. THE CUSTOMER NOTICED ISSUES WITH QUALITY CONTROL RECOVERY, SO THEY PULLED PREVIOUSLY TESTED PATIENT SAMPLES AND REPEATED THESE ON A SECOND ANALYZER. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE DEEMED CORRECT. THE SAMPLE INITIALLY RESULTED IN A TROPONIN T VALUE OF 11.8 NG/L AND IT REPEATED AS 20.0 NG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23028569 ↗
• MalfunctionJun 20, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T GEN 5 STAT RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS 23 NG/L. THE REPEATED RESULT WAS 17 NG/L. THIS RESULT WAS BELIEVED TO BE CORRECT. THE REPEATED RESULT WAS OBTAINED ON ANOTHER MODULE. THE SAMPLE WAS REPEATED DUE TO FAILED QC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301352 ↗
• MalfunctionJun 20, 2025High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TROPONIN T GEN 5 STAT ON A COBAS E 411 ANALYZER. THE SAMPLE INITIALLY RESULTED IN A TROPONIN T VALUE OF APPROXIMATELY 35 NG/L. ANOTHER SAMPLE COLLECTED FROM THE PATIENT RESULTED IN A TROPONIN T VALUE OF < 6 NG/L, SO THE RESULT FROM THE COMPLAINED SAMPLE WAS QUESTIONED. THE COMPLAINED SAMPLE WAS REPEATED ON A SECOND ANALYZER ON (B)(6) 2025, RESULTING IN A TROPONIN T VALUE OF < 6 NG/L WITH A DATA FLAG. THE CUSTOMER REPEATED THE SAMPLE ON THE ORIGINAL E411 ANALYZER AND IT RESULTED IN A VALUE OF 39.8 NG/L. THE < 6 NG/L VALUE FROM THE SECOND ANALYZER WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296733 ↗
• MalfunctionMay 27, 2025Incorrect Measurement; High Test Results; Non Reproducible Results; Incorrect Measurement; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT TESTED FOR ELECSYS TROPONIN T GEN 5 STAT (TROPONIN T STAT) ON A COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS 24 NG/L FROM THE E601 MODULE IN QUESTION. THE PHYSICIAN QUESTIONED THE RESULT DUE TO THE PATIENT'S AGE. THE SAMPLE WAS REPEATED ON THE E601 MODULE IN QUESTION, WITH A RESULT OF 24 NG/L. THE CUSTOMER REPEATED THE SAMPLE ON A DIFFERENT E601 IN THE LABORATORY, AND THE RESULT WAS 6 NG/L. THE SAMPLE WAS REPEATED ON THIS 2ND MODULE, AND THE RESULT WAS AGAIN "WITHIN THE NORMAL RANGE." THE ACTUAL RESULT WAS NOT PROVIDED. THE RESULT OF 6 NG/L WAS BELIEVED TO BE CORRECT, AND THE RESULT WAS AMENDED IN THE PATIENT¿S CHART. THE CUSTOMER REPLACED THE REAGENT PACKS ON BOTH MODULES AND PERFORMED CALIBRATION AND QC. THE SAMPLE WAS REPEATED ON BOTH MODULES, AND THE RESULT WAS "ELEVATED" ON THE E601 MODULE IN QUESTION AND "NORMAL" ON THE 2ND E601 MODULE. THE ACTUAL RESULTS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087045 ↗
• MalfunctionMay 22, 2025Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS TROPONIN T G5 STAT RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E411 RACK. THE RESULT OF A BASELINE PATIENT SAMPLE AT 4:00 PM WAS 226 NG/L. THE INITIAL RESULT FROM THE ANALYZER OF THE NEXT TIMED PATIENT SAMPLE AT 6:00 PM WAS 28 NG/L. THE REPEAT RESULT FROM ANOTHER E411 ANALYZER OF THE NEXT TIMED PATIENT SAMPLE AT 6:11 PM WAS 229 NG/L. THE NEXT TIMED PATIENT SAMPLE'S INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AS IT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE, PROMPTING THE RERUN. THE REPEAT RESULT WAS DEEMED CORRECT AND REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069491 ↗
• MalfunctionApr 23, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS TROPONIN T GEN 5 STAT RESULT FROM THE COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS 69 NG/L, AND THE REPEAT RESULT WAS 6 NG/L, ACCOMPANIED BY A DATA FLAG. THE INITIAL RESULT WAS QUESTIONED BY THE MEDICAL STAFF, AND A REPEAT WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21893720 ↗
• MalfunctionMar 27, 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 RECEIVED A QUESTIONABLE ELECSYS TROPONIN T G5 STAT RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E411 RACK. THE INITIAL RESULT WAS 17.69 NG/L. THE REPEAT RESULT WAS 1248 NG/L. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AS IT WAS DEEMED LOW AND DID NOT MATCH THE PATIENT'S HISTORY, PROMPTING THE RERUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708409 ↗
• MalfunctionFeb 11, 2025Incorrect Measurement; High Test Results; Non Reproducible Results; Incorrect Measurement; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS TROPONIN T GEN 5 STAT ASSAY (TROPONIN T STAT) ON A COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL RESULT WAS 152.6 NG/L WITH A DATA FLAG. THE NURSE QUESTIONED THIS RESULT AND REPEAT TESTING WAS PERFORMED. THE REPEAT FROM A DIFFERENT E411 ANALYZER WAS 31.28 NG/L. THE REPEAT FROM THE E411 ANALYZER IN QUESTION WAS 31.60 NG/L WITH A DATA FLAG. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354309 ↗
• MalfunctionJan 10, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T GEN 5 STAT ASSAY RESULTS FROM THE COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS 521 NG/L, WHICH WAS QUESTIONED BY THE MEDICAL STAFF. A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND THE TROPONIN T RESULT WAS 13.4 MG/L. THE REPEAT RESULT FOR THE FIRST SAMPLE USING ANOTHER ANALYZER WAS 12.83 NG/L THE REPEAT RESULT FOR THE FIRST SAMPLE USING THE ORIGINAL ANALYZER WAS 14.3 NG/L. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21129345 ↗
• MalfunctionJul 11, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T GEN 5 STAT ASSAY RESULTS FROM THE COBAS E411 RACK. SAMPLE 1 THE INITIAL RESULT WAS 12 NG/L AND THE REPEAT RESULTS WERE 1042 NG/L AND 1016 NG/L. ON (B)(6) 2024, SAMPLE 2 INITIAL RESULT WAS 12.66 NG/L AND THE REPEAT RESULT WAS 138.2 NG/L. THE SAMPLES WERE REPEATED AS THE PHYSICIAN QUESTIONED THE INITIAL RESULTS. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19719196 ↗
• MalfunctionJul 9, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T STAT ASSAY RESULTS FOR 1 PATIENT SERUM SAMPLE ON A COBAS 8000 - COBAS E 602 MODULE. THE INITIAL TROPONIN RESULT WAS 7 NG/L. THE CUSTOMER WAS PROMPTED TO REPEAT THE SAMPLE AS THE INITIAL RESULT WAS ACCOMPANIED BY TWO ANALYZER ALARMS. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE RESULT WAS 22 NG/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19701630 ↗
• MalfunctionJul 2, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED THE RESULTS FOR 5 PATIENT SAMPLES TESTED FOR ELECSYS TROPONIN T GEN 5 STAT ASSAY (TROPONIN T STAT) ON A COBAS E 601 MODULE. THE CUSTOMER PROVIDED AN EXAMPLE OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE. THE INITIAL RESULT WAS APPROXIMATELY 25 NG/ML WITH A DATA FLAG. DUE TO THE DATA FLAG, THE SAMPLE WAS REPEATED ON A DIFFERENT E601 MODULE WITH A RESULT OF APPROXIMATELY 50 NG/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655974 ↗
• MalfunctionApr 25, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS TROPONIN T G5 STAT RESULT FROM A PATIENT SAMPLE TESTED ON THE COBAS E411 RACK CU. THE INITIAL RESULT WAS REPORTED TO THE PROVIDER. THE DISCREPANT RESULTS WERE NOTED WHEN THE REPORTER WAS PERFORMING A REAGENT LOT-TO-LOT COMPARISON TEST. THE INITIAL RESULT WAS 93 NG/L. THE FIRST REPEAT RESULT WAS 7 NG/L. THE SECOND REPEAT RESULT WAS 7 NG/L. THE THIRD REPEAT RESULT WAS 7 NG/L. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183523 ↗
• MalfunctionApr 19, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TROPONIN T GEN 5 STAT ASSAY ON A COBAS E411 DISK. THE SAMPLE INITIALLY RESULTED IN A TROPONIN T VALUE OF 62 NG/ML. THE PROVIDER REQUESTED A REPEAT OF THE SAMPLE. THE SAMPLE WAS REPEATED, RESULTING IN A TROPONIN T VALUE OF < 6 NG/ML. THE REPEAT VALUE WAS DEEMED CORRECT AND AGREED WITH THE PATIENT'S HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19145388 ↗
• MalfunctionFeb 14, 2024High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS TROPONIN T G5 STAT RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 6000 E601 MODULE. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER STATED THAT THEY DID NOT INTENTIONALLY RUN A DILUTION, BUT THE RESULT SHOWED A RATIO OF 10. THE INITIAL RESULT WAS DEEMED HIGH PROMPTING THE RERUN OF THE PATIENT SAMPLE. THE INITIAL RESULT FROM THE OTHER MODULE WAS 36.46 NG /L. THE FIRST REPEAT RESULT FROM THE MODULE WAS 94.85 NG /L. THE SECOND REPEAT RESULT FROM THE OTHER MODULE WAS 35.47 NG/L. THE THIRD REPEAT RESULT FROM THE OTHER MODULE WAS 34.77 NG/L. THE RESULT OF 36 NG/L WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18701926 ↗
• MalfunctionJul 24, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS TROPONIN T GEN 5 STAT ASSAY (TROPONIN T STAT) ON A COBAS 8000 E 602 MODULE. THE INITIAL RESULT AT 7:19 P.M. WAS 31.50 NG/L WITH A DATA FLAG. AT 7:24 P.M. THE TECHNICIAN REPEATED THE SAMPLE WITH A MANUAL DILUTION OF 1:10 AND THE RESULT WAS 60.00 NG/L WITH A DATA FLAG. THE REPEAT RESULT AT 11:59 P.M. WAS 26.05 NG/L WITH A DATA FLAG. THE INITIAL RESULT OF 31.50 NG/L WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375961 ↗
• MalfunctionApr 17, 2023High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION OF A QUESTIONABLE RESULT FOR 1 PATIENT'S PLASMA SAMPLE TESTED WITH THE ELECSYS TROPONIN T HS (TNTHS) GEN 5 STAT ASSAY ON COBAS 6000 E601 IMMUNOANALYZER SERIAL NUMBER (B)(4). INITIAL RESULT: 20 NG/L THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY AND THE PHYSICIAN MENTIONED THAT IT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. THE SAMPLE WAS THEN REPEATED. REPEAT RESULT: 6 NG/L THE REPEAT RESULT DEEMED TO BE CORRECT. QC WAS ACCEPTABLE ON THE DAY OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16756191 ↗
• MalfunctionApr 10, 2023Mechanical Problem; High Test Results; Mechanical Problem; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE HIGH TROPONIN T G5 STAT ELECSYS RESULT FROM COBAS 6000 E 601 MODULE SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 12.66 NG/L AND WAS NOT REPORTED OUTSIDE OF THE LABORATORY AS THE USER THOUGHT IT WAS AN UNBELIEVABLE RESULT. THE REPEAT RESULT WAS 10.85 NG/L AND WAS BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16706416 ↗
• MalfunctionApr 10, 2023Mechanical Problem; High Test Results; Mechanical Problem; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE HIGH TROPONIN T G5 STAT ELECSYS RESULT FROM COBAS 6000 E 601 MODULE SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 21.44 NG/L AND WAS NOT REPORTED OUTSIDE OF THE LABORATORY AS THE USER THOUGHT IT WAS AN UNBELIEVABLE RESULT. THE REPEAT RESULT WAS <6 NG/L AND WAS BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16706412 ↗