Dimension Vista® Flex® reagent cartridge CTNI 10445098Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 00842768015151), received between Oct 11, 2017 and Sep 13, 2021 — classified as 76 malfunctions.

The most frequently reported specific device problem is “High Test Results” (66 reports).

1 other recall cover devices cleared under the same FDA submission (K063756); 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 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2021Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED PATIENT SAMPLE CARDIAC TROPONIN I (CTNI) RESULT WAS OBTAINED ON A DIMENSION VISTA® 500 SYSTEM ON A SAMPLE DILUTION PROCESSED AFTER AN INITIAL MEASUREMENT ERROR FLAG WAS OBTAINED. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE DIMENSION VISTA® 500 SYSTEM AND A MEASUREMENT ERROR FLAG WAS OBTAINED. THE SAME SAMPLE WAS PROCESSED ON AN ALTERNATE INSTRUMENT, AT AN ALTERNATE SITE AND A HIGHER CTNI RESULT WAS OBTAINED. THE REPROCESSED, HIGHER CTNI RESULT WAS CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN. THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CTNI RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12462680 ↗
• MalfunctionFeb 22, 2021Unable to Obtain Readings; Unable to Obtain Readings

  A CUSTOMER REPORTED THAT THERE WAS A DELAY IN PATIENT TREATMENT OF APPROXIMATELY 2.5 HOURS DUE TO THE INABILITY TO OBTAIN AN UNFLAGGED RESULT WHEN PROCESSING A PATIENT SAMPLE FOR CARDIAC TROPONIN I (CTNI) ON A DIMENSION VISTA 500 SYSTEM. THE INITIAL PLASMA SAMPLE PRODUCED AN ERROR FLAG AND WAS NOT REPORTED. THE CUSTOMER COLLECTED NEW PLASMA AND SERUM SAMPLES. THE NEW PLASMA SAMPLE PRODUCED THE SAME MEASUREMENT ERROR. THE CUSTOMER THEN PROCESSED THE SERUM SAMPLE AND OBTAINED AN UNFLAGGED RESULT. THE RESULT WAS CONSIDERED TRUE FOR THE PATIENT AND WAS REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING A CTNI RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11357596 ↗
• MalfunctionFeb 17, 2021High Test Results

  A DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (CTNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 SYSTEM. THE DISCREPANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED WITH DILUTIONS ON THE SAME SYSTEM AND AN ALTERNATE DIMENSION VISTA. NO CORRECTED RESULT WAS OBTAINED OR REPORTED. THE PATIENT WAS RELEASED FROM THE FACILITY BY THE PHYSICIAN. THERE WAS NO ALLEGATION OF PATIENT HARM DUE TO THE DISCORDANT ELEVATED CTNI RESULT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11340177 ↗
• MalfunctionJan 26, 2021High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (CTNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 SYSTEM. THE DISCREPANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS EXAMINED WITH ULTRASOUND AND ANGIOGRAPHY ON AN UNDISCLOSED DATE DURING A PERIOD OF HOSPITALIZATION AND NOTHING ABNORMAL WAS FOUND. THE PATIENT'S ARTHRITIS MEDICATION WAS DISCONTINUED AND HE WAS TREATED FOR PERICARDITIS / MYOCARDITIS. THE CTNI RESULT WAS QUESTIONED AT A LATER DATE WHEN ANOTHER SAMPLE FROM THE PATIENT RESULTED WITHIN THE REFERENCE RANGE FOR CREATINE KINASE MB SUBUNIT TESTING. THERE WAS NO ALLEGATION OF PATIENT HARM DUE TO THE DISCORDANT ELEVATED CTNI RESULT OR THE PROCEDURE OR TREATMENT CHANGE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11232458 ↗
• MalfunctionJan 26, 2021High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (CTNI) RESULTS WERE OBTAINED ON A DIMENSION VISTA 1500 SYSTEM. THE DISCREPANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS EXAMINED WITH ULTRASOUND AND ANGIOGRAPHY ON AN UNDISCLOSED DATE DURING A PERIOD OF HOSPITALIZATION AND NOTHING ABNORMAL WAS FOUND. THE PATIENT'S ARTHRITIS MEDICATION WAS DISCONTINUED AND HE WAS TREATED FOR PERICARDITIS / MYOCARDITIS. THE CTNI RESULTS WERE QUESTIONED AT A LATER DATE WHEN ANOTHER SAMPLE FROM THE PATIENT RESULTED WITHIN THE REFERENCE RANGE FOR CREATINE KINASE MB SUBUNIT TESTING. THERE WAS NO ALLEGATION OF PATIENT HARM DUE TO THE DISCORDANT ELEVATED CTNI RESULTS OR THE PROCEDURE OR TREATMENT CHANGE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11232455 ↗
• MalfunctionJan 26, 2021High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (CTNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 SYSTEM. THE DISCREPANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS EXAMINED WITH ULTRASOUND AND ANGIOGRAPHY ON AN UNDISCLOSED DATE DURING A PERIOD OF HOSPITALIZATION AND NOTHING ABNORMAL WAS FOUND. THE PATIENT'S ARTHRITIS MEDICATION WAS DISCONTINUED AND HE WAS TREATED FOR PERICARDITIS / MYOCARDITIS. THE CTNI RESULT WAS QUESTIONED A SAMPLE ON THE SAME DATE FROM THE PATIENT RESULTED WITHIN THE REFERENCE RANGE FOR CREATINE KINASE MB SUBUNIT TESTING. THERE WAS NO ALLEGATION OF PATIENT HARM DUE TO THE DISCORDANT ELEVATED CTNI RESULT OR THE PROCEDURE OR TREATMENT CHANGE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11232417 ↗
• MalfunctionJan 26, 2021High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (CTNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 SYSTEM. THE DISCREPANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS EXAMINED WITH ULTRASOUND AND ANGIOGRAPHY ON AN UNDISCLOSED DATE DURING A PERIOD OF HOSPITALIZATION AND NOTHING ABNORMAL WAS FOUND. THE PATIENT'S ARTHRITIS MEDICATION WAS DISCONTINUED AND HE WAS TREATED FOR PERICARDITIS / MYOCARDITIS. THE CTNI RESULT WAS QUESTIONED AT A LATER DATE WHEN ANOTHER SAMPLE FROM THE PATIENT RESULTED WITHIN THE REFERENCE RANGE FOR CREATINE KINASE MB SUBUNIT TESTING. THERE WAS NO ALLEGATION OF PATIENT HARM DUE TO THE DISCORDANT ELEVATED CTNI RESULT OR THE PROCEDURE OR TREATMENT CHANGE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11232412 ↗
• MalfunctionJan 26, 2021High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (CTNI) RESULTS WERE OBTAINED ON A DIMENSION VISTA 1500 SYSTEM. THE DISCREPANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS EXAMINED WITH ULTRASOUND AND ANGIOGRAPHY ON AN UNDISCLOSED DATE DURING A PERIOD OF HOSPITALIZATION AND NOTHING ABNORMAL WAS FOUND. THE PATIENT'S ARTHRITIS MEDICATION WAS DISCONTINUED AND HE WAS TREATED FOR PERICARDITIS / MYOCARDITIS. THE CTNI RESULTS WERE QUESTIONED AT A LATER DATE WHEN ANOTHER SAMPLE FROM THE PATIENT RESULTED WITHIN THE REFERENCE RANGE FOR CREATINE KINASE MB SUBUNIT TESTING. THERE WAS NO ALLEGATION OF PATIENT HARM DUE TO THE DISCORDANT ELEVATED CTNI RESULTS OR THE PROCEDURE OR TREATMENT CHANGE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11232395 ↗
• MalfunctionJan 26, 2021High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (CTNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 SYSTEM. THE DISCREPANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS EXAMINED WITH ULTRASOUND AND ANGIOGRAPHY ON AN UNDISCLOSED DATE DURING A PERIOD OF HOSPITALIZATION AND NOTHING ABNORMAL WAS FOUND. THE PATIENT'S ARTHRITIS MEDICATION WAS DISCONTINUED AND HE WAS TREATED FOR PERICARDITIS / MYOCARDITIS. THE CTNI RESULT WAS QUESTIONED AT A LATER DATE WHEN ANOTHER SAMPLE FROM THE PATIENT RESULTED WITHIN THE REFERENCE RANGE FOR CREATINE KINASE MB SUBUNIT TESTING. THERE WAS NO ALLEGATION OF PATIENT HARM DUE TO THE DISCORDANT ELEVATED CTNI RESULT OR THE PROCEDURE OR TREATMENT CHANGE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11232368 ↗
• MalfunctionJan 26, 2021High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (CTNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 SYSTEM. THE DISCREPANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS EXAMINED WITH ULTRASOUND AND ANGIOGRAPHY ON AN UNDISCLOSED DATE DURING A PERIOD OF HOSPITALIZATION AND NOTHING ABNORMAL WAS FOUND. THE PATIENT'S ARTHRITIS MEDICATION WAS DISCONTINUED AND HE WAS TREATED FOR PERICARDITIS / MYOCARDITIS. THE CTNI RESULT WAS QUESTIONED AT A LATER DATE WHEN ANOTHER SAMPLE FROM THE PATIENT RESULTED WITHIN THE REFERENCE RANGE FOR CREATINE KINASE MB SUBUNIT TESTING. THERE WAS NO ALLEGATION OF PATIENT HARM DUE TO THE DISCORDANT ELEVATED CTNI RESULT OR THE PROCEDURE OR TREATMENT CHANGE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11232346 ↗
• MalfunctionJan 26, 2021High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (CTNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 SYSTEM. THE DISCREPANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS EXAMINED WITH ULTRASOUND AND ANGIOGRAPHY ON AN UNDISCLOSED DATE DURING A PERIOD OF HOSPITALIZATION AND NOTHING ABNORMAL WAS FOUND. THE PATIENT'S ARTHRITIS MEDICATION WAS DISCONTINUED AND HE WAS TREATED FOR PERICARDITIS / MYOCARDITIS. THE CTNI RESULT WAS QUESTIONED AT A LATER DATE WHEN ANOTHER SAMPLE FROM THE PATIENT RESULTED WITHIN THE REFERENCE RANGE FOR CREATINE KINASE MB SUBUNIT TESTING. THERE WAS NO ALLEGATION OF PATIENT HARM DUE TO THE DISCORDANT ELEVATED CTNI RESULT OR THE PROCEDURE OR TREATMENT CHANGE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11232338 ↗
• MalfunctionJan 26, 2021High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (CTNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 SYSTEM. THE DISCREPANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS EXAMINED WITH ULTRASOUND AND ANGIOGRAPHY ON AN UNDISCLOSED DATE DURING A PERIOD OF HOSPITALIZATION AND NOTHING ABNORMAL WAS FOUND. THE PATIENT'S ARTHRITIS MEDICATION WAS DISCONTINUED AND HE WAS TREATED FOR PERICARDITIS / MYOCARDITIS. THE CTNI RESULT WAS QUESTIONED AT A LATER DATE WHEN ANOTHER SAMPLE FROM THE PATIENT RESULTED WITHIN THE REFERENCE RANGE FOR CREATINE KINASE MB SUBUNIT TESTING. THERE WAS NO ALLEGATION OF PATIENT HARM DUE TO THE DISCORDANT ELEVATED CTNI RESULT OR THE PROCEDURE OR TREATMENT CHANGE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11232288 ↗
• MalfunctionJan 26, 2021High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (CTNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 SYSTEM. THE DISCREPANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS EXAMINED WITH ULTRASOUND AND ANGIOGRAPHY ON AN UNDISCLOSED DATE DURING A PERIOD OF HOSPITALIZATION AND NOTHING ABNORMAL WAS FOUND. THE PATIENT'S ARTHRITIS MEDICATION WAS DISCONTINUED AND HE WAS TREATED FOR PERICARDITIS / MYOCARDITIS. THE CTNI RESULT WAS QUESTIONED AT A LATER DATE WHEN ANOTHER SAMPLE FROM THE PATIENT RESULTED WITHIN THE REFERENCE RANGE FOR CREATINE KINASE MB SUBUNIT TESTING. THERE WAS NO ALLEGATION OF PATIENT HARM DUE TO THE DISCORDANT ELEVATED CTNI RESULT OR THE PROCEDURE OR TREATMENT CHANGE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11231069 ↗
• MalfunctionNov 19, 2020High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN (CTNI) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA® 500 SYSTEM. THE INITIAL RESULT WAS NOT REPORTED, BUT WAS REPROCESSED WITH AN AUTO-DILUTION. THE DILUTED SAMPLE RESULTED HIGHER THAN THE INITIAL RESULT, AND THAT RESULT WAS REPORTED. THE CUSTOMER REALIZED THAT THE REPROCESSED RESULT WAS DISCORDANT AND ISSUED A CORRECTED REPORT WITH THE INITIAL RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CTNI RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10871460 ↗
• MalfunctionAug 10, 2020High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (CTNI) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN (S) AND WERE QUESTIONED. THE SAME SAMPLE WAS REPROCESSED TWICE ON AN ALTERNATE NON-SIEMENS INSTRUMENT AND LOWER 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 DISCORDANT CTNI RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10385846 ↗
• MalfunctionDec 11, 2019Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED CARDIAC TROPONIN I (CTNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAME SAMPLE WAS ALSO PROCESSED AFTER DILUTION AND A HIGHER RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CTNI RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9453942 ↗
• MalfunctionJul 9, 2019High Test Results; High Test Results

  DISCORDANT ELEVATED CARDIAC TROPONIN I (CTNI) RESULTS WERE OBTAINED ON QUALITY CONTROL (QC) AND PATIENT'S SAMPLES ON A DIMENSION VISTA 1500 INSTRUMENT. THE PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME PATIENT SAMPLES WERE REPROCESSED ON AN ALTERNATE DIMENSION VISTA. LOWER RESULTS WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CTNI RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8771181 ↗
• MalfunctionJun 21, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (CTNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAME SAMPLE WAS ALSO PROCESSED USING THE SIEMENS HIGH SENSITIVITY TROPONIN I (TNIH) ASSAY AND A LOWER RESULT WAS OBTAINED. THE SAME SAMPLE WAS REPROCESSED ON TWO ALTERNATE NON-SIEMENS METHODOLOGIES AND LOWER RESULTS WERE OBTAINED RELATIVE TO THE CUSTOMER'S RESPECTIVE REFERENCE RANGES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CTNI RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8722506 ↗
• MalfunctionJun 21, 2019High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (CTNI) RESULTS WERE OBTAINED ON PATIENT'S SAMPLES ON A DIMENSION VISTA 1500 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAME SAMPLES WERE PROCESSED ON THE SAME INSTRUMENT USING THE SIEMENS HIGH SENSITIVITY TROPONIN I (TNIH) ASSAY AFTER THE HIGH CTNI RESULTS WERE OBTAINED. THE CUSTOMER INDICATED THE TNIH METHOD WAS BEING VALIDATED. LOWER RESULTS WERE OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED CTNI RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8722504 ↗
• MalfunctionJun 21, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (CTNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAME SAMPLE WAS ALSO PROCESSED USING THE SIEMENS HIGH SENSITIVITY TROPONIN I (TNIH) METHOD AND A LOWER RESULT WAS OBTAINED. THE SAME SAMPLE WAS REPROCESSED ON TWO ALTERNATE NON-SIEMENS METHODOLOGIES AND LOWER RESULTS WERE OBTAINED RELATIVE TO THE CUSTOMER'S RESPECTIVE REFERENCE RANGES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CTNI RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8722503 ↗
• MalfunctionJun 3, 2019Low Test Results; Low Test Results

  DISCORDANT, FALSELY DEPRESSED CARDIAC TROPONIN I (CTNI) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON THE DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON TWO ALTERNATE VISTA INSTRUMENTS AND HIGHER RESULTS WERE OBTAINED AND CORRECTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CTNI RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8662980 ↗
• MalfunctionJun 3, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (CTNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. THE SAMPLE WAS PROCESSED DILUTED AFTER A NON-REPORTABLE FLAGGED RESULT WAS OBTAINED ON AN ALTERNATE DIMENSION VISTA SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE SAME VISTA SYSTEM AND A LOWER RESULT WAS OBTAINED. THE CUSTOMER CALLED THE PHYSICIAN AND ADVISED THE PHYSICIAN TO DISREGARD THE RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CTNI RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8662958 ↗
• MalfunctionJun 3, 2019Incorrect Measurement; Incorrect Measurement

  A DISCORDANT CARDIAC TROPONIN I (CTNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE RESULT WAS DEEMED INVALID BY THE LABORATORY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CTNI RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8662956 ↗
• MalfunctionMay 3, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (CTNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE SAME INSTRUMENT AND A LOWER RESULT WAS OBTAINED AND REPORTED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CTNI RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8579482 ↗
• MalfunctionMay 3, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (CTNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE SAME INSTRUMENT AND A LOWER RESULT WAS OBTAINED AND REPORTED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CTNI RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8579481 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063756. One submission often covers many models, so check the product and lot details in each record.

• Z-1671-2018 · Jan 2, 2018 · Terminated
  Dimension Vista Cardiac Troponin I (CTNI) Flex reagent cartridge