Dimension® EXL™ LOCI® Module Flex® reagent cartridge TNI 10464525Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00842768022067), received between Jun 22, 2017 and Oct 14, 2022 — classified as 66 malfunctions.

The most frequently reported specific device problem is “High Test Results” (57 reports).

4 other recalls cover devices cleared under the same FDA submission (K081643); 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 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2022High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED CARDIAC TROPONIN I (TNI) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION EXL 200 SYSTEM. THE FALSELY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S) AND THE RESULT WAS QUESTIONED. A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND PROCESSED ON THE SAME DIMENSION EXL 200 SYSTEM. A LOWER TNI RESULT, CONSIDERED CORRECT, WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CARDIAC TROPONIN I (TNI) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15605388 ↗
• MalfunctionDec 16, 2021High Test Results; High Test Results

  ELEVATED CARDIAC TROPONIN I (TNI) QUALITY CONTROL (QC) SAMPLE RESULTS WERE OBTAINED ON A DIMENSION EXL 200 SYSTEM. THE ELEVATED TNI QC RESULTS WERE ABOVE THE LABORATORY ACCEPTANCE RANGE. THE CUSTOMER STATED THAT TNI PATIENT SAMPLE RESULT REPORTING WAS DELAYED. THE DURATION OF THE DELAY WAS NOT PROVIDED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE OUT OF ACCEPTANCE RANGE TNI QUALITY CONTROL RESULTS OR THE DELAY IN PATIENT SAMPLE RESULT REPORTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019585 ↗
• MalfunctionAug 17, 2021High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED CARDIAC TROPONIN I (TNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL W/LM SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED TNI RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12334166 ↗
• MalfunctionAug 17, 2021High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED CARDIAC TROPONIN I (TNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL W/LM SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. A SAMPLE FROM THE PATIENT WAS PROCESSED ON THE SAME DATE WITH AN ALTERNATE, NON-SIEMENS METHODOLOGY AND A LOWER RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED TNI RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12334165 ↗
• MalfunctionAug 17, 2021High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED CARDIAC TROPONIN I (TNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL W/LM SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED TNI RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12334163 ↗
• MalfunctionAug 17, 2021High Test Results; High Test Results

  DISCORDANT FALSELY ELEVATED CARDIAC TROPONIN I (TNI) RESULTS WERE OBTAINED WITH ONE PATIENT'S SAMPLES ON A DIMENSION EXL W/LM SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULTS. ONE SAMPLE WAS LATER REPROCESSED WITH AN ALTERNATE, NON-SIEMENS METHODOLOGY AND A LOWER RESULT, CONSIDERED CORRECT, WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED TNI RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12334162 ↗
• MalfunctionJul 30, 2020High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (TNI) RESULTS WERE OBTAINED ON A PATIENT'S SAMPLES ON A DIMENSION EXL 200 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAME SAMPLES WERE PROCESSED ON AN ALTERNATE NON-SIEMENS METHODOLOGY AND LOWER RESULTS WERE OBTAINED. THE PATIENT WAS SENT TO A HOSPITAL WHERE A CT CORONARY ANGIOGRAM, EKG, AND A CHEST X-RAY WERE PERFORMED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED TNI RESULTS OR TREATMENTS.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 10344772 ↗
• MalfunctionJul 30, 2020High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (TNI) RESULTS WERE OBTAINED ON A PATIENT'S SAMPLES ON A DIMENSION EXL 200 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAME SAMPLES WERE PROCESSED ON A DIFFERENT TNI LOT AND LOWER RESULTS WERE OBTAINED. THE PATIENT WAS SENT TO A HOSPITAL WHERE AN ECHOCARDIOGRAM AND A CHEST X-RAY WERE PERFORMED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED TNI RESULTS OR TREATMENTS.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 10344670 ↗
• MalfunctionJul 30, 2020High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (TNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS PROCESSED ON A DIFFERENT TNI LOT AND A LOWER RESULT WAS OBTAINED. THE PATIENT WAS SENT TO A HOSPITAL WHERE AN ECHOCARDIOGRAM AND A CHEST X-RAY WERE PERFORMED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED TNI RESULTS OR TREATMENTS.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 10344668 ↗
• MalfunctionJul 2, 2020Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED CARDIAC TROPONIN I (TNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPEATED WITH AN ALTERNATE LOT OF THE CARDIAC TROPONIN I ASSAY AND A HIGHER RESULT, CONSIDERED CORRECT WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THE SAME PATIENT SAMPLE WAS PROCESSED ON AN ALTERNATE DIMENSION EXL WITH LM SYSTEM. A DISCORDANT FALSELY DEPRESSED TNI RESULT WAS OBTAINED WITH ONE TNI LOT AND A LOWER RESULT WAS OBTAINED WITH THE ALTERNATE TNI LOT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED CARDIAC TROPONIN I(TNI) RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10224496 ↗
• MalfunctionDec 12, 2019High Test Results; High Test Results

  DISCORDANT FALSELY ELEVATED CARDIAC TROPONIN I (TNI) RESULTS WERE OBTAINED ON A PATIENT'S SERUM AND PLASMA SAMPLES ON A DIMENSION EXL 200 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED TNI RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9460946 ↗
• MalfunctionDec 12, 2019High Test Results; High Test Results

  DISCORDANT FALSELY ELEVATED CARDIAC TROPONIN I (TNI) RESULTS WERE OBTAINED ON A PATIENT'S SERUM AND PLASMA SAMPLES ON A DIMENSION EXL 200 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. WHOLE BLOOD SAMPLE FROM THE SAME PATIENT WAS PROCESSED AGAIN ON THE NON-SIEMENS ALTERNATE METHODOLOGY AND A LOWER RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED TNI RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9460943 ↗
• MalfunctionDec 3, 2019Unexpected Therapeutic Results; High Test Results; Unexpected Therapeutic Results; High Test Results

  ELEVATED A CARDIAC TROPONIN I (TNI) RESULTS WERE OBTAINED ON PATIENT SERUM SAMPLES ON A DIMENSION EXL 200 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE RESULTS OBTAINED WERE CONSIDERED CORRECT BASED ON THE PATIENT'S PREVIOUS HISTORY OF A POSITIVE TNI RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED TNI RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9405702 ↗
• MalfunctionDec 3, 2019Unexpected Therapeutic Results; High Test Results; Unexpected Therapeutic Results; High Test Results

  AN ELEVATED CARDIAC TROPONIN I (TNI) RESULT WAS OBTAINED ON A PATIENT SERUM SAMPLE ON A DIMENSION EXL 200 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. A CARDIAC CATHETERIZATION WAS PERFORMED ON THE PATIENT AND THE CATHETERIZATION RESULT WAS NEGATIVE. THE RESULT WAS LATER DETERMINED TO BE CORRECT BASED ON THE PATIENT'S PREVIOUS HISTORY OF A POSITIVE TNI RESULT. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED TNI RESULT OR THE CATHETERIZATION PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9405685 ↗
• MalfunctionDec 3, 2019Unexpected Therapeutic Results; High Test Results; Unexpected Therapeutic Results; High Test Results

  AN ELEVATED CARDIAC TROPONIN I (TNI) RESULT WAS OBTAINED ON A PATIENT SERUM SAMPLE ON A DIMENSION EXL 200 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE TNI RESULT OBTAINED WAS CONSIDERED CORRECT BASED ON THE PATIENT'S PREVIOUS HISTORY OF A (B)(6) TNI RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED TNI RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9405680 ↗
• MalfunctionDec 2, 2019High Test Results; High Test Results

  A DISCORDANT ELEVATED CARDIAC TROPONIN I (TNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPROCESSED ON ONE ALTERNATE NON-SIEMENS METHODOLOGY AND A LOWER RESULT WAS OBTAINED. THE SAME SAMPLE WAS REPROCESSED ON A SECOND ALTERNATE NON-SIEMENS METHODOLOGY AND A LOWER RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9397414 ↗
• MalfunctionDec 2, 2019High Test Results; High Test Results

  A DISCORDANT ELEVATED CARDIAC TROPONIN I (TNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT AND SENT THE PATIENT TO AN ALTERNATE FACILITY FOR A NEW SAMPLE TO BE DRAWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9397376 ↗
• MalfunctionOct 15, 2019High Test Results; High Test Results

  DISCORDANT ELEVATED CARDIAC TROPONIN I (TNI) RESULTS WERE OBTAINED ON A PATIENT'S SAMPLES ON A DIMENSION EXL INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN. A LOWER RESULT WAS OBTAINED ON A WHOLE BLOOD SAMPLE FROM THE PATIENT ON THE SAME DAY ON AN ALTERNATE NON-SIEMENS SYSTEM AT THE USER FACILITY. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY AND A NEW SAMPLE TESTED THE SAME DAY AT THE ALTERNATE FACILITY ALSO RESULTED LOWER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9194649 ↗
• MalfunctionOct 15, 2019Mechanical Problem; Mechanical Problem

  DISCORDANT, FALSELY HIGH CARDIAC TROPONIN (TNI) PATIENT RESULTS WERE OBTAINED ON A DIMENSION EXL 200 INSTRUMENT. THE INITIAL RESULT FOR SID (B)(6) WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. A NEW SAMPLE WAS DRAWN UNDER SID (B)(6), ON THE SAME PATIENT AND REPEATED ON THE SAME INSTRUMENT, RESULTING IN A LOWER VALUE. ADDITIONALLY, BOTH SAMPLES WERE REPEATED ON THE SAME INSTRUMENT, RESULTING IN A LOWER VALUE. THE INITIAL RESULTS FOR SID (B)(6) AND (B)(6) WERE REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAME SAMPLES WERE REPEATED ON THE SAME INSTRUMENT, RESULTING IN LOWER VALUES. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). IT WAS REPORTED THAT A PATIENT (SID (B)(6)) RECEIVED UNNECESSARY MEDICATION AS A RESULT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9191437 ↗
• MalfunctionOct 11, 2019High Test Results; High Test Results

  A DISCORDANT, ELEVATED CARDIAC TROPONIN I (TNI) RESULT WAS OBTAINED ON A PATIENT SERUM/PLASMA SAMPLE ON A DIMENSION EXL 200 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPROCESSED ON THE SAME INSTRUMENT AND HIGHER RESULTS WERE OBTAINED; THE HIGHER RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND PROCESSED ON AN ALTERNATE NON-SIEMENS INSTRUMENT IN AN ALTERNATE FACILITY; A LOWER RESULT WAS OBTAINED WHICH WAS CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9181904 ↗
• MalfunctionOct 11, 2019High Test Results; High Test Results

  DISCORDANT, FALSE ELEVATED CARDIAC TROPONIN I (TNI) RESULTS WERE OBTAINED ON PATIENT SERUM/PLASMA SAMPLES ON A DIMENSION EXL 200 INSTRUMENT. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). A PRIOR LOWER RESULT FROM THE SAME INSTRUMENT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9181902 ↗
• MalfunctionOct 11, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (TNI) RESULT WAS OBTAINED ON A PATIENT SERUM/PLASMA SAMPLE ON A DIMENSION EXL 200 INSTRUMENT S/N (B)(4). THE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). A PRIOR LOWER RESULT FROM THE SAME PATIENT ON AN ALTERNATE SIEMENS INSTRUMENT S/N (B)(4) WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPROCESSED ON AT AN ALTERNATE FACILITY AND OBTAINED A LOWER RESULT WHICH WAS CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9181901 ↗
• MalfunctionJul 26, 2019High Test Results; High Test Results

  DISCORDANT FALSELY ELEVATED CARDIAC TROPONIN I (TNI) RESULTS WERE OBTAINED ON A DILUTED REPROCESSED PATIENT SAMPLE ON A DIMENSION EXL 200 INSTRUMENT. THE CUSTOMER PERFORMED A DILUTION ON THE PATIENT SAMPLE AFTER A BELOW ASSAY RANGE WAS OBTAINED FOR THE INITIAL RESULT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAME DILUTED SAMPLE WAS REPROCESSED ON THE SAME DAY AT A LATER TIME ON THE SAME INSTRUMENT AND A HIGHER RESULT WAS OBTAINED. THE SAME SAMPLE WAS REPROCESSED UNDILUTED ON THE NEXT DAY ON THE SAME INSTRUMENT AND A LOWER RESULT WAS OBTAINED. A CORRECTED REPORT WAS ISSUED WITH THE LOWER UNDILUTED RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED CARDIAC TROPONIN I RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8832547 ↗
• MalfunctionJun 28, 2019High Test Results; High Test Results

  DISCORDANT, ELEVATED CARDIAC TROPONIN I (TNI) RESULTS WERE OBTAINED ON A PATIENT'S SAMPLES ON A DIMENSION EXL 200 INSTRUMENT. THE DIMENSION EXL RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE PATIENT SAMPLES HAD INITIALLY BEEN PROCESSED ON THE SAME DAY ON A NON-SIEMENS INSTRUMENT RESULTING LOWER BUT ABOVE THE CUSTOMER'S REFERENCE RANGE FOR THAT TROPONIN I METHODOLOGY. THE PATIENT SAMPLES WERE ALSO PROCESSED ON A SECOND NON-SIEMENS INSTRUMENT WITH A TROPONIN T METHODOLOGY. THE RESULTS WERE LOWER BUT ALSO ABOVE THE REFERENCE INTERVAL FOR THAT METHODOLOGY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8745139 ↗
• MalfunctionJun 28, 2019High Test Results; High Test Results

  DISCORDANT, ELEVATED CARDIAC TROPONIN I (TNI) RESULTS WERE OBTAINED ON A PATIENT'S SAMPLES ON A DIMENSION EXL 200 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS TRANSFERRED TO AN ALTERNATE FACILITY WHERE NEW SAMPLES WERE PROCESSED THE SAME DAY ON A NON-SIEMENS INSTRUMENT AND THE RESULTS OBTAINED WERE LOWER BUT ABOVE THE CUSTOMER'S REFERENCE RANGE FOR THAT TROPONIN I METHODOLOGY. THE PATIENT SAMPLES WERE ALSO PROCESSED ON A SECOND NON-SIEMENS INSTRUMENT WITH A TROPONIN T METHODOLOGY. THE RESULTS WERE LOWER BUT ALSO ABOVE THE REFERENCE INTERVAL FOR THAT METHODOLOGY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8745075 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081643. One submission often covers many models, so check the product and lot details in each record.

• Z-2436-2018 · Mar 21, 2018 · Terminated
  Dimension Vista CTNI Sample Diluent, KD692, SMN# 10445205
• Z-2606-2017 · Mar 21, 2017 · Terminated
  Dimension Troponin 1 (TNI) Flex reagent cartridge
• Z-0069-2012 · Aug 31, 2011 · Terminated
  Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges
• Z-0460-2011 · Apr 12, 2010 · Terminated
  The Dimension TNI Flex reagent cartridge (Cardiac Troponin), manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE.