Dimension EXL LOCI Troponin I High Sensitive 10471068Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 00842768037726), received between Feb 24, 2020 and Feb 16, 2026 — classified as 76 malfunctions.

The most frequently reported specific device problem is “High Test Results” (61 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Aug 19, 2020Class IITerminated

   Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control lot. The average bias observed for patient samples using lots EB0255 and EA0178 of the Dimension EXL Troponin compared with a control lot was +25%. A maximum bias of +34% in patient samples around the 99th percentile observed

   Z-0052-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED DIMENSION EXL HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING LOT FC6102. AN INITIAL ELEVATED RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE PATIENT WAS REDRAWN AFTER ONE HOUR, AND THE REDRAWN SAMPLE WAS RETESTED ON THE SAME SYSTEM, YIELDING A LOWER RESULT. BOTH THE INITIAL AND REDRAWN SAMPLES WERE SUBSEQUENTLY RETESTED ON THE ORIGINAL SYSTEM AND ON AN ALTERNATE SYSTEM, PRODUCING LOWER RESULTS CONSISTENT WITH THE REDRAWN SAMPLE RESULT. THE LOWER RESULT WAS CONSIDERED CORRECT, AND A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT RESULTING FROM THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343045 ↗
• MalfunctionJan 9, 2026High Test Results

  THE CUSTOMER REPORTED OBSERVATION OF AN ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING AT AN ALTERNATE HOSPITAL WHEN USING LOT FB6082. AN INITIAL ELEVATED RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN. BASED ON THIS RESULT, THE PHYSICIAN REFERRED THE PATIENT TO AN ALTERNATE HOSPITAL APPROXIMATELY 3 TO 4 HOURS AWAY DUE TO CONCERN FOR A POSSIBLE CARDIAC EVENT. AT THE ALTERNATE HOSPITAL, A NEW SAMPLE WAS COLLECTED AND TESTED USING AN UNKNOWN METHODOLOGY, WHICH YIELDED A LOWER RESULT. THE LOWER RESULT WAS CONSIDERED CORRECT SINCE IT RECOVERED WITHIN THE NORMAL RANGE AND WAS REPORTED TO THE PHYSICIAN. THERE ARE NO ALLEGATIONS OF PATIENT HARM OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24018579 ↗
• MalfunctionDec 24, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY ELEVATED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. AN INITIAL ELEVATED RESULT WAS OBTAINED ON A PATIENT SAMPLE. THIS RESULT WAS REPORTED TO THE PHYSICIAN(S) BUT NOT QUESTIONED. THE PATIENT WAS REDRAWN TWICE, AND THE SAMPLES WERE PROCESSED ON THE ORIGINAL SYSTEM. ADDITIONALLY, THE FIRST REDRAWN SAMPLE WAS REPROCESSED ON THE ORIGINAL SYSTEM. THE REDRAWN SAMPLES YIELDED LOWER RESULTS. THESE LOWER RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). A CORRECTED REPORT WAS ISSUED BASED ON THE REDRAWN SAMPLE TESTING. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887734 ↗
• MalfunctionNov 14, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TO SIEMENS THAT ERRONEOUS LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. AN INITIAL LOW RESULT WITH AN ¿ASSAY RANGE¿ FLAG WAS OBTAINED. THE SAMPLE WAS DILUTED AND REPROCESSED TWICE ON THE ORIGINAL SYSTEM USING REAGENT-GRADE WATER. THE REPROCESSED RESULTS WERE HIGHER THAN THE INITIAL RESULT AND HAD NO FLAGS. NONE OF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) AS THE ORDER GOT CANCELED. THE CORRECT RESULT IS UNKNOWN FOR THIS PATIENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTIONS OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23551836 ↗
• MalfunctionNov 14, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TO SIEMENS THAT ERRONEOUS LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. AN INITIAL LOW RESULT WITH AN ¿ASSAY RANGE¿ FLAG WAS OBTAINED. THE SAMPLE WAS DILUTED AND REPROCESSED TWICE ON THE ORIGINAL SYSTEM USING REAGENT-GRADE WATER. THE REPROCESSED RESULTS WERE HIGHER THAN THE INITIAL RESULT AND HAD NO FLAGS. ONE OF THESE HIGHER REPROCESSED RESULTS WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. AFTER TWO DAYS, THE SAMPLE WAS REPROCESSED THREE TIMES ON THE ORIGINAL SYSTEM; TWO OF THESE REPROCESSED RESULTS RECOVERED LOW WITH AN ¿ASSAY RANGE¿ FLAG AND MATCHED THE INITIAL RESULT. THE OTHER REPROCESSED RESULT WAS LOWER THAN THE ERRONEOUS RESULTS WITH NO FLAG. THE LOWER REPROCESSED RESULT WITH NO FLAG WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTIONS OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23551830 ↗
• MalfunctionJul 24, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY DEPRESSED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. INITIALLY THE SAMPLE WAS PROCESSED ON THE ORIGINAL DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM AND A HIGHER RESULT WAS OBTAINED CONSIDERED CORRECT AND THE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS AUTO REPROCESSED ON THE ORIGINAL DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM, A LOWER RESULT WAS OBTAINED, CONSIDERED ERRONEOUSLY DEPRESSED AND REPORTED TO THE PHYSICIAN(S). A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND PROCESSED ON THE ORIGINAL DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM AND A HIGHER RESULT WAS OBTAINED. THE SAME SAMPLE WAS AUTO REPROCESSED ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM AND A HIGHER RESULT WAS OBTAINED. THE NEW SAMPLE RESULTS WERE CONSISTENT WITH THE INITIAL RESULT, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THE INITIAL SAMPLE WAS REPROCESSED AGAIN ON THE ORIGINAL DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM AND A HIGHER RESULT WAS OBTAINED CONSISTENT WITH NEW SAMPLE RESULTS AND THE INITIAL RESULT, CONSIDERED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587860 ↗
• MalfunctionJun 9, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED AN ERRONEOUSLY DEPRESSED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT ON ONE (1) PATIENT SAMPLE OBTAINED ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON BOTH THE ORIGINAL DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM AND AN ALTERNATE DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. A HIGHER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168178 ↗
• MalfunctionJun 2, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED AN ERRONEOUSLY ELEVATED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT ON ONE (1) PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE INITIAL RESULT FOR THE SAME SAMPLE, OBTAINED ON THE ORIGINAL DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM, WAS A LOWER RESULT, WHICH WAS CONSIDERED CORRECT AND NOT REPORTED TO THE PHYSICIAN. FOLLOWING THE ERRONEOUSLY ELEVATED RESULT, THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND NOT REPORTED TO THE PHYSICIAN. A NEW SAMPLE FROM THE SAME PATIENT WAS DRAWN AND PROCESSED TWICE ON THE ORIGINAL DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. LOWER RESULTS WERE OBTAINED AND CONSIDERED CORRECT. ONE OF THE RE-DRAWN RESULTS WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127119 ↗
• MalfunctionMay 22, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED AN ERRONEOUSLY DEPRESSED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT ON ONE (1) PATIENT SAMPLE ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. A HIGHER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072251 ↗
• MalfunctionMay 15, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED AN ERRONEOUSLY ELEVATED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT ON A PATIENT SAMPLE ON THE DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE INITIAL ERRONEOUSLY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. A LOWER RESULT WAS OBTAINED AND CONSIDERED CORRECT. THE SAME SAMPLE WAS REPROCESSED ON TWO ALTERNATE DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEMS. LOWER RESULTS WERE OBTAINED AND CONSIDERED CORRECT. A SECOND SAMPLE FOR THE SAME PATIENT WAS PROCESSED ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. A LOWER RESULT WAS OBTAINED AND CONSIDERED CORRECT. BOTH SAMPLES FROM THE SAME PATIENT WERE REPROCESSED ON ALTERNATE DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEMS. LOWER RESULTS WERE OBTAINED AND CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED LOCI HIGH SENSITIVITY TROPONIN I (TNIH) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22030538 ↗
• MalfunctionMay 7, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED AN ERRONEOUSLY DEPRESSED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT ON ONE (1) PATIENT SAMPLE ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE INITIAL RESULT FOR THE SAME SAMPLE, OBTAINED ON THE ORIGINAL DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM, WAS A HIGHER RESULT, WHICH WAS CONSIDERED CORRECT AND NOT REPORTED TO THE PHYSICIAN. FOLLOWING THE ERRONEOUSLY DEPRESSED RESULT, THE SAME SAMPLE WAS REPROCESSED TWO MORE TIMES ON THE ORIGINAL DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. HIGHER RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976943 ↗
• MalfunctionMar 17, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED AN ERRONEOUSLY ELEVATED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT ON ONE (1) PATIENT SAMPLE ON A DIMENSION EXL 200 SYSTEM. THE ERRONEOUSLY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION EXL 200 SYSTEM. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620197 ↗
• MalfunctionJan 28, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY DEPRESSED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM AND A HIGHER RESULT WAS OBTAINED. THE HIGHER REPROCESSED RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. TWO NEW SAMPLES WERE DRAWN FROM THE SAME PATIENT AND PROCESSED AT DIFFERENT TIMES DURING PATIENT ADMISSION FOR CORRELATION STUDY PURPOSES, THE RESULTS OBTAINED WERE HIGHER AND CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21250472 ↗
• MalfunctionJan 24, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED AN ERRONEOUSLY DEPRESSED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT ON ONE (1) PATIENT SAMPLE AT THE TWO (2) HOURS REDRAW ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM SN (B)(6). THE ERRONEOUSLY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME TWO (2) HOUR SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM SN (B)(6). A HIGHER RESULT WAS OBTAINED AND CONSIDERED CORRECT SINCE IT CORRELATED WITH THE ORIGINAL ZERO HOUR PATIENT SAMPLE RESULT AND WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229446 ↗
• MalfunctionJan 23, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED AN ERRONEOUSLY ELEVATED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT ON A PATIENT SAMPLE ON THE DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE RESULT WAS FROM A REDRAWN SAMPLE (B)(6) 2025) AND WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. THE SAME SAMPLE REPROCESSED AT AN ALTERNATE FACILITY USING AN ALTERNATE SIEMENS METHOD (ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)). A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. THE CUSTOMER HAD OBTAINED ERRONEOUSLY ELEVATED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) PATIENT RESULTS FROM A PREVIOUS SAMPLE DRAW (B)(6) 2025) ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED LOCI HIGH SENSITIVITY TROPONIN I (TNIH) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218101 ↗
• MalfunctionJan 23, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED ONE (1) ERRONEOUSLY ELEVATED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON A QUICK TEST (METHOD UNKNOWN). NEGATIVE RESULT OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A HALF DAY AND DISCHARGED WITHOUT DIAGNOSIS. THE PATIENT WAS NOT TREATED DUE TO THE TNIH ERRONEOUSLY ELEVATED RESULT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED LOCI HIGH SENSITIVITY TROPONIN I (TNIH) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218025 ↗
• MalfunctionDec 31, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY DEPRESSED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS ON TWO (2) PATIENT SAMPLES WHEN REPROCESSED ON A DIMENSION EXL 200 SYSTEM. THE INITIAL RESULTS OBTAINED USING NO DILUTION WERE CONSIDERED CORRECT AND NOT REPORTED TO THE PHYSICIAN(S). SAMPLE IDENTIFIER (B)(6) WAS REPROCESSED USING 1:10 DILUTION, AND SAMPLE IDENTIFIER (B)(6) WAS REPROCESSED USING 1:20 DILUTION ON THE ORIGINAL DIMENSION EXL 200 SYSTEM. LOWER REPROCESSED RESULTS WERE OBTAINED AND CONSIDERED ERRONEOUSLY DEPRESSED. THE ERRONEOUSLY DEPRESSED RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND THE RESULTS WERE NOT QUESTIONED. LATER, SAMPLE IDENTIFIER (B)(6) WAS REPROCESSED USING 1:8 DILUTION, AND SAMPLE IDENTIFIER (B)(6) WAS REPROCESSED USING 1:20 DILUTION ON THE ORIGINAL DIMENSION EXL 200 SYSTEM. HIGHER REPROCESSED RESULTS WERE OBTAINED AND CONSIDERED CORRECT. CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21046313 ↗
• MalfunctionNov 20, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED LOCI HIGH SENSITIVITY TROPONIN I (TNIH) PATIENT SAMPLE RESULTS WERE OBTAINED ON A DIMENSION® EXL¿ INTEGRATED CHEMISTRY SYSTEM. THE PATIENT RESULTS WERE REPORTED AND QUESTIONED BY THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON A SIEMENS ATELLICA IM ANALYZER (ALTERNATE SIEMENS METHOD AT THE CUSTOMER SITE) AND AN ALTERNATE (NON-SIEMENS) SYSTEM AT AN TESTING ALTERNATE SITE. LOWER RESULTS WERE OBTAINED. A NEW SAMPLE WAS DRAWN AND PROCESSED ON TWO ALTERNATE NON-SIEMENS SYSTEMS. LOWER RESULTS WERE OBTAINED. ALL THE RESULTS COMPARED TO THEIR RESPECTIVE CUT-OFF WERE ELEVATED (ABOVE THE 99TH%ILE). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED LOCI HIGH SENSITIVITY TROPONIN I (TNIH) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20738949 ↗
• MalfunctionNov 11, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS ERRONEOUSLY DEPRESSED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS WERE OBTAINED ON TWO DIFFERENT BLOOD DRAWS FROM THE SAME PATIENT ON A DIMENSION EXL 200 SYSTEM. THE ERRONEOUS PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAMPLES FROM THE SAME TWO BLOOD DRAWS WERE ALSO PROCESSED ON A SIEMENS ATELLICA IM ANALYZER. THE HIGHER RESULTS FROM THE ATELLICA IM ANALYZER WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20657658 ↗
• MalfunctionNov 11, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS ERRONEOUSLY DEPRESSED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS WERE OBTAINED ON TWO DIFFERENT BLOOD DRAWS FROM THE SAME PATIENT ON A DIMENSION EXL 200 SYSTEM. THE ERRONEOUS PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAMPLES FROM THE SAME TWO BLOOD DRAWS WERE ALSO PROCESSED ON A SIEMENS ATELLICA IM ANALYZER. THE HIGHER RESULTS FROM THE ATELLICA IM ANALYZER WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20657507 ↗
• MalfunctionSep 26, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED AN ERRONEOUSLY DEPRESSED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM SYSTEM. THE ERRONEOUSLY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN, AND THE RESULT WAS NOT QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION EXL WITH LM SYSTEM. A HIGHER REPROCESSED RESULT WAS OBTAINED, WHICH MATCHED THE PATIENT'S CLINICAL PICTURE AND WAS CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED LOCI HIGH SENSITIVITY TROPONIN I (TNIH) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20308940 ↗
• MalfunctionSep 21, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED SIEMENS HEALTHINEERS REGARDING AN ERRONEOUSLY ELEVATED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION® EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY ELEVATED PATIENT RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON ANOTHER DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM AND AN ATELLICA IM ANALYZER. THE SAME SAMPLE WAS REPROCESSED ON TWO (2) NON-SIEMENS ANALYZERS. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20275353 ↗
• MalfunctionAug 27, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS ON ONE (1) PATIENT WERE OBTAINED ON A DIMENSION EXL 200 SYSTEM. ONE OF THE INITIAL ERRONEOUSLY ELEVATED TNIH RESULTS OBTAINED ON A PLASMA SAMPLE WAS REPORTED TO THE PHYSICIAN(S). THE OTHER ERRONEOUSLY ELEVATED TNIH RESULT OBTAINED ON A PLASMA SAMPLE WAS NOT REPORTED TO THE PHYSICIAN(S). TWO ERRONEOUSLY ELEVATED TNIH RESULTS OBTAINED ON SERUM SAMPLES FROM THE SAME PATIENT WERE OBTAINED FOR VERIFICATION PURPOSES ONLY AND NOT REPORTED. A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND TESTED ON AN ALTERNATE, NON-SIEMENS INSTRUMENT. LOWER TNIH RESULTS WERE OBTAINED ON THE NON-SIEMENS INSTRUMENT AND REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULTS. THE PATIENT WAS SENT TO THE EMERGENCY ROOM (ER) FACILITY AFTER THE ERRONEOUSLY ELEVATED TNIH RESULTS WERE OBTAINED BUT WAS NOT ADMITTED. THE PATIENT WAS SENT HOME ONCE THE CORRECT RESULT WAS REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED TNIH RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20081141 ↗
• MalfunctionAug 20, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY DEPRESSED LOCI HIGH SENSITIVITY TROPONIN I (TNIH) RESULT ON A PATIENT SAMPLE ON A DIMENSION EXL SYSTEM. THE ERRONEOUSLY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION EXL SYSTEM TWICE. HIGHER REPROCESSED RESULTS WERE OBTAINED AND CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED LOCI HIGH SENSITIVITY TROPONIN I (TNIH) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20002529 ↗
• MalfunctionJul 26, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED LOCI HIGH SENSITIVITY TROPONIN I (TNIH) RESULT ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM SYSTEM. THE ERRONEOUSLY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION EXL WITH LM SYSTEM TWICE. LOWER REPROCESSED RESULTS WERE OBTAINED AND CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED LOCI HIGH SENSITIVITY TROPONIN I (TNIH) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19836628 ↗