Elecsys Troponin T Gen 5 STAT 07398000160Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04015630942695), received between Jul 25, 2018 and Feb 13, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2024Incorrect Measurement; Non Reproducible Results; Incorrect Measurement; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T STAT ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE INITIAL TROPONIN RESULT WAS 13.64 PG/ML. THE PATIENT HAD SUBSEQUENT SAMPLES COLLECTED THAT GAVE RESULTS AROUND 750 PG/ML WHICH PROMPTED THE DOCTOR TO QUESTION THE INITIAL RESULT. THE INITIAL SAMPLE WAS REPEATED AND THE REPEAT RESULT WAS 680 PG/ML. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696497 ↗
• MalfunctionOct 24, 2023Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T HS ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE INITIAL TROPONIN RESULT WAS 14.87 NG/L. ANOTHER SAMPLE WAS COLLECTED FROM THE PATIENT THAT GAVE A RESULT OF 66.41 NG/L WHICH PROMPTED THE CUSTOMER TO REPEAT THE PREVIOUS SAMPLE. THE INITIAL SAMPLE WAS REPEATED AND THE RESULT WAS 66.92 NG/L. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17998273 ↗
• MalfunctionMay 19, 2023Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information; Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information

  THERE WAS AN ALLEGATION OF QUESTIONABLE TROPONIN T GEN5 STAT ELECSYS RESULT FROM COBAS E411 DISK ANALYZER SERIAL NUMBER (B)(6). PATIENT (B)(6) INITIAL RESULT WAS < 6 NG/L. THE REPEAT RESULTS WERE 8 NG/L AND <6 NG/L. PATIENT (B)(6) INITIAL RESULT WAS 14 NG/L. THE REPEAT RESULTS WERE 11.93 NG/L AND 11.9 NG/L. PATIENT Y INITIAL RESULT WAS AROUND 16 NG/L. THE REPEAT RESULTS WERE 28.8 NG/L AND 29.40 NG/L. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. A CORRECTED REPORT WAS ISSUED FOR SAMPLE Y.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16966708 ↗
• MalfunctionMay 9, 2023Unable to Obtain Readings; Insufficient Device Problem Information; Non Reproducible Results; Unable to Obtain Readings; Insufficient Device Problem Information; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TROPONIN T GEN5 STAT ELECSYS RESULT FROM THE COBAS 6000 E601 MODULE SERIAL NUMBER (B)(6). THE INITIAL RESULT WAS RESULT 28 NG/L AND THE REPEAT RESULT WAS <6 NG/L. IT WAS QUESTIONED BUT NOT PROVIDED WHICH RESULT WAS BELIEVED CORRECT AND IF EITHER RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16896746 ↗
• MalfunctionFeb 3, 2023Incorrect Measurement; Low Test Results; Non Reproducible Results; Incorrect Measurement; Low Test Results; 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 E 411 IMMUNOASSAY ANALYZER. THE PATIENT SAMPLE INITIALLY RESULTED IN A TROPONIN T VALUE OF 17.47 NG/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE RESULT WAS QUESTIONED AS IT DID NOT MATCH THE PATIENT'S HISTORY. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 692.6 NG/L. THE REPEAT VALUE WAS DEEMED CORRECT AND MATCHED THE PATIENT'S HISTORY. THE TROPININ T REAGENT LOT NUMBER WAS 63006301, WITH AN EXPIRATION DATE OF 31-OCT-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16296468 ↗
• MalfunctionDec 14, 2022No Apparent Adverse Event; Non Reproducible Results; No Apparent Adverse Event; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TROPONIN T STAT ASSAY (TROPONIN T STAT) RESULTS FROM THREE SAMPLES FROM THE SAME PATIENT TESTED ON THE CUSTOMER'S COBAS 6000 E 601 MODULE WITH SERIAL NUMBER (B)(4) (MODULE A), THE CUSTOMER'S ALTERNATE E 601 WITH SERIAL NUMBER 28A0-16 (MODULE B) AND ANOTHER LABORATORY'S E 601 WITH SERIAL NUMBER (B)(4) (MODULE C). AN ALIQUOT INITIAL SAMPLE COLLECTED AT 1:38 AM WAS RECEIVED BY THE REPORTER FROM ANOTHER LABORATORY. THE INITIAL RESULT OF THIS ALIQUOT INITIAL SAMPLE AT 5:00 AM FROM MODULE A WAS 22.17 NG/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. A SECOND SAMPLE FROM THE PATIENT COLLECTED AT 2:57 AM WAS RECEIVED BY THE OTHER LABORATORY. THE RESULT OF THE SECOND SAMPLE FROM MODULE C WAS <6 NG/L. THE DOCTOR INFORMED THE OTHER LABORATORY THAT THERE WAS A DRASTIC DIFFERENCE BETWEEN THE RESULTS AND REQUESTED A RERUN. THE ALIQUOT INITIAL SAMPLE RETAINED IN THE OTHER LABORATORY WAS THEN RERUN. THE REPEAT RESULT OF THIS ALIQUOT INITIAL SAMPLE FROM MODULE C WAS <6 NG/L WITH A DATA FLAG. THE REPORTER RERAN THE ALIQUOT INITIAL SAMPLE THEY RECEIVED IN MODULE A AND MODULE B. THE FIRST REPEAT RESULT OF THIS ALIQUOT INITIAL SAMPLE AT 8:00 AM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15982649 ↗
• MalfunctionNov 22, 2022Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TROPONIN T STAT ASSAY (TROPONIN T STAT) RESULTS FOR TWO PATIENT SAMPLES TESTED ON THE COBAS 6000 E 601 MODULE. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR QUESTIONED THE RESULT WHICH PROMPTED A RERUN OF THE PATIENT SAMPLES. THE PATIENT SAMPLES WERE ALSO RERUN ON THEIR OTHER E 601 MODULE. SAMPLE ID (B)(6): THE INITIAL RESULT FROM THE MODULE WAS 6.00 NG/L WITH A DATA FLAG. THE FIRST REPEAT RESULT FROM THE MODULE WAS 29.50 NG/L. THIS REPEAT RESULT MATCHED THE CLINICAL PICTURE AND WAS DEEMED CORRECT. THE SECOND REPEAT RESULT FROM THE OTHER MODULE WAS 30.31 NG/L. THE THIRD REPEAT RESULT FROM THE OTHER MODULE WAS 28.77 NG/L. SAMPLE ID (B)(6): THE INITIAL RESULT FROM THE MODULE WAS 6.02 NG/L. THE FIRST REPEAT RESULT FROM THE MODULE WAS 28.83 NG/L. THIS REPEAT RESULT MATCHED THE CLINICAL PICTURE AND WAS DEEMED CORRECT. THE SECOND REPEAT RESULT FROM THE OTHER MODULE WAS 28.41 NG/L. THE THIRD REPEAT RESULT FROM THE OTHER MODULE WAS 27.48 NG/L. THE REAGENT LOT NUMBER IS 63006301. THE EXPIRATION DATE IS 31-OCT-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15847581 ↗
• MalfunctionOct 31, 2022High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TROPONIN T GEN5 STAT ELECSYS RESULT FROM THE COBAS 6000 E 601 MODULE. THE INITIAL RESULT WAS 127.4 NG/L AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR QUESTIONED THE RESULT AND THE SAMPLE WAS REPEATED WITH A RESULT OF 6.2 NG/L. THE SAME SAMPLE WAS TESTED ON ANOTHER COBAS SYSTEM AND THE RESULT WAS 6.0 NG/L. THE PATIENT WAS REDRAWN AND THE RESULT WAS APPROXIMATELY 6 NG/L. THE REPEAT RESULTS WERE BELIEVED CORRECT. THE REAGENT LOT NUMBER WAS 63006300 WITH AN EXPIRATION DATE OF 31-OCT-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698495 ↗
• MalfunctionOct 25, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF HIGH RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR ELECSYS TROPONIN T STAT ASSAY (TROPONIN T STAT) ON A COBAS 6000 E 601 MODULE. THE CUSTOMER STATED SHE HAD A DOCTOR CALL ABOUT A RESULT. THE CUSTOMER PROVIDED DISCREPANT RESULTS FOR 2 PATIENT SAMPLES. PATIENT 1 INITIAL RESULT WAS 28 NG/L. THE REPEAT ON A DIFFERENT E601 MODULE WAS 14 NG/L. PATIENT 2 INITIAL RESULT WAS 20 NG/L. THE REPEAT ON A DIFFERENT E601 MODULE WAS 6 NG/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE E601 MODULE SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15668544 ↗
• MalfunctionSep 19, 2022High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TROPONIN T STAT ASSAY FROM 1 PATIENT ON A COBAS 6000 E 601 MODULE. FIVE DIFFERENT SAMPLES WERE COLLECTED ON THE SAME DAY. ALL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE HIGH RESULTS WERE QUESTIONED BECAUSE THEY DID NOT FIT THE PATIENT'S CLINICAL PICTURE AND DID NOT CORRELATE WITH THEIR NEGATIVE TNI AND CKMB RESULTS. THE FIRST TNT RESULT WAS 29320 NG/L WITH FLAG. THE SECOND RESULT WAS 29970 NG/L WITH FLAG. THE THIRD RESULT WAS 32011 NG/L WITH FLAG. THE FOURTH RESULT WAS 28683 NG/L WITH FLAG. THE FIFTH RESULT WAS 27632 NG/L SIMILAR RESULTS WERE OBTAINED ON THIS PATIENT ACROSS MULTIPLE ROCHE ANALYZERS AT 2 SITES USING THE SAME REAGENT. THE INSTRUMENT SERIAL NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15450984 ↗
• MalfunctionAug 15, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T STAT ASSAY RESULTS ON A COBAS E 411 ANALYZER, SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 56.08 PG/ML. THE SAMPLE WAS REPEATED DUE TO THE LABORATORY'S POLICY TO REPEAT CRITICAL TROPONIN T STAT RESULTS. THE REPEATED RESULT WAS 92.28 PG/ML. THE CUSTOMER NOTICED THE DISCREPANCY AND DECIDED TO REPEAT THE SAMPLE AGAIN ON A DIFFERENT ANALYZER. THE REPEATED RESULT, OBTAINED ON A DIFFERENT ANALYZER, WAS 49.74 PG/ML. THIS RESULT WAS DEEMED CORRECT. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15225922 ↗
• MalfunctionJul 7, 2022High Test Results; High Test Results

  THE INITIAL REPORTER ALLEGED THEY RECEIVED QUESTIONABLE RESULTS FOR FIVE SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH THE ELECSYS TROPONIN T GEN. 5 STAT ASSAY ON A COBAS 8000 E 602 MODULE (SERIAL NUMBER (B). THE SAMPLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND DID NOT AGREE WITH THE CLINICAL PICTURE OF THE PATIENT. ALL SAMPLES COLLECTED FROM THE PATIENT ALLEGEDLY RESULTED IN TROPONIN T VALUES AROUND 1000 NG/L. THE CUSTOMER ALLEGED THE RESULTS SHOULD BE NEGATIVE ACCORDING TO THE CLINICAL PICTURE OF THE PATIENT. THE CUSTOMER REPORTED THAT DILUTION STUDIES RULED OUT THE POSSIBILITY OF HETEROPHILIC ANTIBODY INTERFERENCE. THE CUSTOMER BELIEVES THE ISSUE MAY BE RELATED TO MACRO TROPONIN T INTERFERENCE BASED ON THE STUDY IN ATTACHMENT 1. REFER TO ATTACHMENT 2 FOR ALL PATIENT DATA. DILUTION STUDIES TO RULE OUT THE POSSIBILITY OF HETEROPHILIC ANTIBODY INTERFERENCE WERE PERFORMED WITH SAMPLE ID (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14949978 ↗
• MalfunctionJul 25, 2018High Test Results; High Readings; High Test Results; High Readings

  A CARDIOLOGIST COMPLAINED OF QUESTIONABLE ELECSYS TROPONIN T GEN5 STAT ASSAY (TNTSTAT5) RESULTS FROM 2 SEPARATE SAMPLES FROM THE SAME PATIENT TESTED ON AN UNKNOWN ANALYZER. THE SPECIFIC DATE OF THE EVENT IS NOT KNOWN AND THE DATE PROVIDED IS ONLY AN APPROXIMATION. THE PATIENT HAD PRESENTED TO THEIR EMERGENCY ROOM WITH CHEST PAIN AND A HISTORY OF NON-ST-ELEVATION MYOCARDIAL INFARCTION (NONSTEMI). THE INITIAL TNTSTAT5 RESULT WAS 1050 NG/L WITH A DATA FLAG. ONE HOUR LATER A NEW SAMPLE WAS COLLECTED WITH A TNTSTAT5 RESULT OF 1040 NG/L WITH A DATA FLAG. THE PATIENT WAS SENT TO THE CATHETERIZATION LABORATORY WHERE THE PATIENT HAD CARDIAC CATHETERIZATION PERFORMED WITH NEGATIVE RESULTS. THE PATIENT'S ARTERIES WERE CLEAR. FOR BOTH PATIENT SAMPLES, THE CUSTOMER RAN TROPONIN T GEN 4, TROPONIN I, AND TROPONIN T AT AN OUTSIDE LABORATORY AND ALL RESULTS CAME BACK NEGATIVE. NO SPECIFIC RESULTS OR FURTHER DETAILS WERE PROVIDED. THE CARDIOLOGIST CONFIRMED THAT THERE IS NO BIOTIN PRESENT, NO HEMOLYSIS IN THE SAMPLE, AND NO HETEROPHILE ANTIBODIES PRESENT. A FIELD ENGINEERING SPECIALIST DID NOT BELIEVE THE ISSUE WAS RELATED TO THE ANALYZER. FURTHER PATIENT INFORMATION INCLUDING ADDITIONAL PATIENT TES

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7720305 ↗