Atellica IM TNIH 10997841Recalls & reported problems

Summary

The FDA's MAUDE database contains 463 adverse event reports that list this exact device (DI 00630414006758), received between Mar 8, 2021 and Sep 17, 2026 — classified as 463 malfunctions.

The most frequently reported specific device problem is “High Test Results” (462 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 463 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026High Test Results

  The customer reports observation of elevated Atellica IM High-Sensitivity Troponin I (TnIH) results which were discordant relative to alternate-method testing when using TnIH lot 115.An initial elevated Atellica IM TnIH result was observed for a 16-year-old male patient. The same sample was re-tested and again produced an elevated TnIH result.The sample was tested again using a Roche Troponin-T assay, and a result below that assay¿s cutoff was obtained. This lower result was accepted as correct, and the Atellica IM TnIH results were identified as falsely elevated. There are no allegations of any adverse patient consequences in association with the observed result discordance.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805152 ↗
• MalfunctionApr 27, 2026High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING TNIH LOT 113. AN ELEVATED INITIAL ATELLICA IM TNIH RESULT WAS OBSERVED FOR A 43-YEAR-OLD MALE PATIENT WITH NO HISTORY OF CARDIAC ISSUES. ANOTHER SAMPLE WAS DRAWN AND TESTED AN HOUR LATER IN THE EMERGENCY ROOM, AND THE RESULT WAS BELOW ASSAY MEASURING RANGE (<2.5 NG/ML). WHEN THE INITIAL SAMPLE WAS RE-TESTED, IT PRODUCED A SIMILAR LOW RESULT. THE LOW TROPONIN RESULTS WERE REPRODUCED IN REPEAT TESTING. THE INITIAL RESULT WAS IDENTIFIED AS FALSELY ELEVATED. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24997367 ↗
• MalfunctionApr 23, 2026High Test Results

  THE CUSTOMER OBTAINED AN ELEVATED ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNIH) RESULT (> 99TH%ILE) ON A PATIENT SAMPLE THAT WAS DISCORDANT COMPARED TO A RESULT OBTAINED ON AN ALTERNATE TEST METHOD. ATELLICA IM TNIH REAGENT LOT 113 WAS IN USE AT THE TIME. THE INITIAL ATELLICA IM TNIH RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN BECAUSE IT WAS ELEVATED BASED ON THE PATIENT'S CLINICAL STATUS (DETAILS WERE NOT PROVIDED). THE SAMPLE WAS SENT TO ANOTHER LAB FOR ALTERNATE METHOD TESTING AND THE RESULT WAS LOWER, BUT ALSO GREATER THAN THE METHOD'S REFERENCE INTERVAL. THIS LOWER RESULT WAS CONSIDERED CORRECT. AND CONSIDERED CORRECT. ANOTHER SAMPLE FROM THE SAME PATIENT WAS DRAWN AND TESTED AT A DIFFERENT LAB ON A DIFFERENT ATELLICA IM ANALYZER FOR COMPARISON. THE RESULT WAS ELEVATED AND SIMILAR TO THE INITIAL ATELLICA IM TNIH RESULT AT THE CUSTOMER SITE. THERE ARE NO ALLEGATIONS OF ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968348 ↗
• MalfunctionApr 22, 2026High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING TNIH LOT: 113. AN ELEVATED ATELLICA IM TNIH RESULT WAS OBSERVED FOR AN 87-YEAR-OLD MALE PATIENT. THIS RESULT WAS NOT TRANSMITTED TO THE DOCTOR. WHEN THE SAME SAMPLE WAS RE-TESTED TWICE ON THE SAME INSTRUMENT, MUCH LOWER RESULTS WERE PRODUCED. A SIMILAR LOW RESULT WAS OBTAINED WHEN THE SAMPLE WAS REPEAT TESTED ON ANOTHER ATELLICA IM INSTRUMENT; THIS RESULT WAS REPORTED AS CORRECT. THE INITIAL RESULT WAS IDENTIFIED AS FALSELY ELEVATED. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE. QUALITY CONTROL (QC) RESULTS WERE WITHIN EXPECTED RANGES JUST BEFORE THIS SAMPLE WAS RUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24952293 ↗
• MalfunctionApr 2, 2026High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING TNIH LOT: 113. AN ELEVATED ATELLICA IM TNIH RESULT WAS OBSERVED FOR A 77-YEAR-OLD MALE PATIENT. THIS RESULT WAS NOT TRANSMITTED TO THE DOCTOR. WHEN A NEW SAMPLE WAS DRAWN AND TESTED ON ANOTHER INSTRUMENT (USING A DIFFERENT REAGENT LOT), A MUCH LOWER RESULT WAS OBTAINED. THE INITIAL SAMPLE WAS RE-TESTED USING BOTH INSTRUMENTS FOLLOWING RE-CENTRIFUGATION, AND SIMILAR LOW RESULTS WERE PRODUCED. THE INITIAL RESULT WAS IDENTIFIED AS FALSELY ELEVATED. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE. QUALITY CONTROL (QC) RESULTS WERE WITHIN EXPECTED RANGES ON BOTH SYSTEMS AT THE TIME OF THESE OBSERVATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24764858 ↗
• MalfunctionMar 10, 2026High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING TNIH LOT 114. A HIGHLY ELEVATED ATELLICA IM TNIH RESULT WAS OBSERVED FOR THE PATIENT IN QUESTION. WHEN THE SAMPLE WAS RE-TESTED THE NEXT DAY (USING A REAGENT LOT 113), A MUCH LOWER RESULT (BELOW MEASUREMENT RANGE) WAS PRODUCED. THE INITIAL RESULT WAS IDENTIFIED AS FALSELY ELEVATED. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557030 ↗
• MalfunctionFeb 3, 2026High Test Results

  INITIAL COMPLAINT SUMMARY: THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING TNIH LOT 112. AN ELEVATED ATELLICA IM TNIH RESULT WAS OBSERVED FOR THE PATIENT IN QUESTION. WHEN THE SAMPLE WAS RE-TESTED, A MUCH LOWER RESULT WAS PRODUCED. TWO NEW SAMPLES TAKEN IN THE FOLLOWING HOURS PRODUCED SIMILAR LOW RESULTS. THE INITIAL RESULT WAS IDENTIFIED AS FALSELY ELEVATED. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245076 ↗
• MalfunctionJan 26, 2026High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING TNIH LOT 112. AN ELEVATED ATELLICA IM TNIH RESULT WAS OBSERVED FOR THE PATIENT IN QUESTION. A NEW SAMPLE TAKEN ONE HOUR LATER PRODUCED A MUCH LOWER RESULT, AS DID ANOTHER SAMPLE TAKEN SEVERAL HOURS LATER. WHEN THE INITIAL SAMPLE WAS RE-TESTED, IT ALSO PRODUCED A SIMILAR LOW RESULT, CONFIRMING THAT THE INITIAL RESULT WAS FALSELY ELEVATED. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24176483 ↗
• MalfunctionNov 12, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING TNIH LOT 112. DURING MONITORING OF A 30-YEAR-OLD MALE PATIENT IN THE EMERGENCY DEPARTMENT, A FALSELY ELEVATED TNIH RESULT WAS OBSERVED DURING A SERIES OF MEASUREMENTS. FOLLOWING AN INITIAL LOW TNIH RESULT, AN ELEVATED RESULT WAS SEEN IN THE SECOND TEST (~3.5 HOURS AFTER INITIAL TEST), WHICH WAS FOLLOWED BY LOW RESULTS FOR TWO SUBSEQUENT SAMPLES. REPEAT TESTING OF THE DISCORDANT SECOND SAMPLE USING TWO INSTRUMENTS PRODUCED LOW RESULTS, THE PATIENT UNDERWENT A CARDIAC CONSULTATION WHICH DID NOT REVEAL ANY ISSUES. THE ELEVATED RESULT WAS IDENTIFIED AS ERRONEOUS. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23531640 ↗
• MalfunctionOct 23, 2025High Test Results; High Test Results

  THE CUSTOMER OBTAINED ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) LOT 111 RESULTS ON 3 SAMPLES, EACH FROM A DIFFERENT PATIENT. THE RESULTS WERE > 99TH PERCENTILE AND WERE REPORTED TO THE PHYSICIANS, WHO QUESTIONED THE RESULTS, AS THEY WERE HIGHER THAN EXPECTED. THE PATIENTS WERE SUBSEQUENTLY REFERRED TO A HOSPITAL FOR FURTHER EVALUATION. NO INFORMATION WAS AVAILABLE FROM THE HOSPITAL, EXCEPT THE HOSPITAL RESULTS WERE LOWER THAN THE CUSTOMER'S INITIAL RESULTS AND DID NOT CONFIRM A HEART ATTACK. IT IS UNKNOWN IF THE PATIENTS WERE SERIALLY TESTED OR UNDERWENT OTHER TESTING OR TREATMENT AT THE HOSPITAL. THE CUSTOMER IS UNABLE TO PROVIDE ADDITIONAL INFORMATION. THE CUSTOMER WAS INFORMED OF THE DISCORDANCE BETWEEN THEIR INITIAL RESULTS AND THE HOSPITAL RESULTS, WHICH PROMPTED THEM TO SEND THEIR INITIAL SAMPLES TO OTHER LABS FOR FOLLOW-UP TESTING ON ANOTHER ATELLICA IM ANALYZER AS WELL AS ALTERNATE METHODS. THE ALTERNATE METHOD RESULTS WERE ABOVE EACH METHOD¿S REFERENCE RANGE, EXCEPT FOR ONE RESULT. THERE HAVE BEEN NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372843 ↗
• MalfunctionJul 21, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS AN OBSERVATION OF AN ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT, WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA IM ANALYZER AND THE ORIGINAL ANALYZER. THE REPEAT RESULTS RECOVERED LOWER THAN THE INITIAL RESULT, WERE SAME AND CONSIDERED CORRECT. THESE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553721 ↗
• MalfunctionJul 15, 2025High Test Results; High Test Results

  THE CUSTOMER OBTAINED AN ELEVATED ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNIH) PATIENT SAMPLE RESULT THAT WAS DISCORDANT RELATIVE TO AN ALTERNATE TEST METHOD. THE CUSTOMER OBTAINED AN ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNIH) PATIENT SAMPLE RESULT THAT WAS ELEVATED (> THAN THE ASSAY REFERENCE RANGE). THE RESULT WAS REPORTED TO THE PHYSICIAN AND THE PATIENT WAS SUBSEQUENTLY SENT TO THE HOSPITAL. THE PATIENT WAS RETESTED AT THE HOSPITAL USING AN ALTERNATE METHOD AND THE RESULT WAS WITHIN THE METHOD'S REFERENCE RANGE. THE PATIENT ALSO HAD A NORMAL ECG, THEREFORE THE LOW/NORMAL RESULTS WERE CONSIDERED CORRECT. AS A RESULT OF THE DISCORDANCE, THE CUSTOMER PERFORMED RETESTING ON THE INITIAL SAMPLE FOR TROUBLESHOOTING AND RESULTS REMAILED ELEVATED. CALIBRATION AND QUALITY CONTROL (QC) WAS ACCEPTABLE AT THE TIME OF ALL CUSTOMER TESTING. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22510802 ↗
• MalfunctionMay 23, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING TNIH LOT 109. AN INITIAL ELEVATED ATELLICA IM TNIH RESULT WAS OBTAINED THE PATIENT IN QUESTION. A SAMPLE DRAWN ONE HOUR LATER PRODUCED A MUCH LOWER RESULT, AS DID A TWO-HOUR SAMPLE. RE-TESTING OF THE INITIAL SAMPLE PRODUCED A LOWER RESULT CONSISTENT WITH THE 1- AND 2-HOUR SAMPLING. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077538 ↗
• MalfunctionMay 23, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING TNIH LOT 109. AN INITIAL ELEVATED ATELLICA IM TNIH RESULT WAS OBTAINED THE PATIENT IN QUESTION. A SAMPLE DRAWN ONE HOUR LATER PRODUCED A MUCH LOWER RESULT, AS DID A TWO-HOUR SAMPLE. RE-TESTING OF THE INITIAL SAMPLE PRODUCED A LOWER RESULT CONSISTENT WITH THE 1- AND 2-HOUR SAMPLING. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077509 ↗
• MalfunctionMay 22, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED AN ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING TNIH LOT 109. AN INITIAL ELEVATED ATELLICA IM TNIH RESULT WAS OBTAINED FOR A 71-YEAR-OLD MALE PATIENT. A SAMPLE DRAWN ONE HOUR LATER PRODUCED MUCH LOWER RESULTS, WHICH WERE CONSISTENT ACROSS REPLICATES. THE INITIAL SAMPLE WAS THEN RE-TESTED TWICE, PRODUCING MUCH LOWER RESULTS MORE CONSISTENT WITH THOSE SEEN AT ONE HOUR. AN ADDITIONAL SAMPLE WAS DRAWN AND TESTED, AND IT PRODUCED RESULTS CONSISTENT WITH THOSE FROM THE INITIAL 1-HOUR SAMPLE. WHEN THESE SAMPLES WERE LATER REPEAT-TESTED IN TRIPLICATE ON AN ATELLICA CI ANALYZER, THE RESULTS WERE ALL CONSISTENT WITH THE LOWER OBSERVATIONS FROM THE ATELLICA IM INSTRUMENT. THE INITIAL DISCORDANT, ELEVATED RESULT WAS NEVER REPRODUCED. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069185 ↗
• MalfunctionMar 25, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED AN ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING USING AND ALTERNATE METHOD AND FOLLOWING DILUTION WHEN USING TNIH LOT 104. AN INITIAL ELEVATED ATELLICA IM TNIH RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION. THIS RESULT WAS QUESTIONED BY THE PHYSICIAN AND NOT ACCEPTED AS CORRECT. THE SAME SAMPLE WAS RE-TESTED MULTIPLE TIMES FOR PURPOSES OF INVESTIGATION/TROUBLESHOOTING. THE SAMPLE WAS TESTED USING THE SAME METHOD AT ANOTHER LAB, AND AN EVEN HIGHER RESULT WAS PRODUCED. WHEN THE SAMPLE WAS TESTED USING AN ALTERNATE ASSAY METHOD, A MUCH LOWER RESULT (BELOW APPLICABLE CUTOFF WAS OBTAINED. THIS RESULT WAS CONSIDERED CORRECT. ANOTHER ATELLICA IM TNIH TEST PRODUCED ANOTHER ELEVATED RESULT. BUT WHEN THE SAMPLE WAS DILUTED, MUCH LOWER RESULTS (BELOW REFERENCE THRESHOLD) WERE PRODUCED IN TWO SUCCESSIVE TESTS. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691073 ↗
• MalfunctionMar 12, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS AN OBSERVATION OF AN ELEVATED ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNIH) RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE METHOD TESTING WHEN USING TNIH KIT LOT 107. AN INITIAL ELEVATED RESULT WAS OBTAINED FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS RETESTED ON AN ALTERNATE METHOD AND OBTAINED A LOWER RESULT. THE LOWER RESULT MATCHED THE CLINICAL DIAGNOSIS OF THE PATIENT AND WAS ISSUED ON THE CORRECTED REPORT 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 21582039 ↗
• MalfunctionJan 9, 2025High Test Results; High Test Results

  THE CUSTOMER OBTAINED AN ELEVATED ATELLICA IM TROPONIN I (TNIH) PATIENT RESULT (> THAN 99TH%) FOR A 62-YEAR-OLD MALE BEING TREATED FOR HYPERTENSION. THE LOT NUMBER IN USE HAS NOT BEEN PROVIDED. THE INITIAL ATELLICA IM TNIH RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAMPLE WAS RETESTED, AND ACCORDING TO THE CUSTOMER, AN IDENTICAL RESULT WAS OBTAINED. THE CUSTOMER ALLEGES THE ELEVATED RESULTS TO BE FALSE POSITIVE. A CORRECTED REPORT WAS ISSUED, BUT THE CORRECT/TRUE RESULT HAS NOT BEEN PROVIDED. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21117950 ↗
• MalfunctionJan 9, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS FOR ONE PATIENT WHICH WERE DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND ALTERNATE-METHOD TESTING. THE CUSTOMER REPORTS REPEAT OBSERVATION OF DISCORDANT, ELEVATED ATELLICA IM TNIH RESULTS FOR AN OBSTETRIC PATIENT OVER A PERIOD OF SEVERAL MONTHS. DISCORDANT OBSERVATIONS WERE ASSOCIATED WITH MULTIPLE SAMPLE DRAWS, OVER A PERIOD BETWEEN (B)(6) 2024. THE CUSTOMER INDICATES THAT THE ELEVATED RESULTS (APPROXIMATELY 4,000 PG/ML) ARE REPRODUCIBLE ACROSS TWO LABORATORY LOCATIONS AND THREE DIFFERENT ATELLICA IM INSTRUMENTS. ONE RECENT SAMPLE WAS TESTED FOR TROPONIN I AND TROPONIN T USING ALTERNATE-METHOD TESTING AT AN EXTERNAL LAB AND PRODUCED ¿NEGATIVE¿ RESULTS (BELOW REFERENCE CUTOFFS FOR THOSE ASSAYS). THE LOWER RESULTS WERE CONSIDERED CORRECT, AS THEY WERE CONSISTENT WITH THE PATIENT¿S CLINICAL PICTURE, WHERE NO CARDIAC ISSUES OR DISEASE HAVE BEEN IDENTIFIED. THE SERIES OF HIGH ATELLICA IM TNIH RESULTS HAS BEEN IDENTIFIED AS FALSELY ELEVATED. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112377 ↗
• MalfunctionJan 9, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS FOR ONE PATIENT WHICH WERE DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND ALTERNATE-METHOD TESTING. THE CUSTOMER REPORTS REPEAT OBSERVATION OF DISCORDANT, ELEVATED ATELLICA IM TNIH RESULTS FOR AN OBSTETRIC PATIENT OVER A PERIOD OF SEVERAL MONTHS. DISCORDANT OBSERVATIONS WERE ASSOCIATED WITH MULTIPLE SAMPLE DRAWS, OVER A PERIOD BETWEEN (B)(6) 2024. THE CUSTOMER INDICATES THAT THE ELEVATED RESULTS (APPROXIMATELY 4,000 PG/ML) ARE REPRODUCIBLE ACROSS TWO LABORATORY LOCATIONS AND THREE DIFFERENT ATELLICA IM INSTRUMENTS. ONE RECENT SAMPLE WAS TESTED FOR TROPONIN I AND TROPONIN T USING ALTERNATE-METHOD TESTING AT AN EXTERNAL LAB AND PRODUCED ¿NEGATIVE¿ RESULTS (BELOW REFERENCE CUTOFFS FOR THOSE ASSAYS). THE LOWER RESULTS WERE CONSIDERED CORRECT, AS THEY WERE CONSISTENT WITH THE PATIENT¿S CLINICAL PICTURE, WHERE NO CARDIAC ISSUES OR DISEASE HAVE BEEN IDENTIFIED. THE SERIES OF HIGH ATELLICA IM TNIH RESULTS HAS BEEN IDENTIFIED AS FALSELY ELEVATED. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112374 ↗
• MalfunctionJan 9, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS FOR ONE PATIENT WHICH WERE DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND ALTERNATE-METHOD TESTING. THE CUSTOMER REPORTS REPEAT OBSERVATION OF DISCORDANT, ELEVATED ATELLICA IM TNIH RESULTS FOR AN OBSTETRIC PATIENT OVER A PERIOD OF SEVERAL MONTHS. DISCORDANT OBSERVATIONS WERE ASSOCIATED WITH MULTIPLE SAMPLE DRAWS, OVER A PERIOD BETWEEN (B)(6) 2024. THE CUSTOMER INDICATES THAT THE ELEVATED RESULTS (APPROXIMATELY 4,000 PG/ML) ARE REPRODUCIBLE ACROSS TWO LABORATORY LOCATIONS AND THREE DIFFERENT ATELLICA IM INSTRUMENTS. ONE RECENT SAMPLE WAS TESTED FOR TROPONIN I AND TROPONIN T USING ALTERNATE-METHOD TESTING AT AN EXTERNAL LAB, AND PRODUCED ¿NEGATIVE¿ RESULTS (BELOW REFERENCE CUTOFFS FOR THOSE ASSAYS). THE LOWER RESULTS WERE CONSIDERED CORRECT, AS THEY WERE CONSISTENT WITH THE PATIENT¿S CLINICAL PICTURE, WHERE NO CARDIAC ISSUES OR DISEASE HAVE BEEN IDENTIFIED. THE SERIES OF HIGH ATELLICA IM TNIH RESULTS HAS BEEN IDENTIFIED AS FALSELY ELEVATED. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112312 ↗
• MalfunctionJan 9, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS FOR ONE PATIENT WHICH WERE DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND ALTERNATE-METHOD TESTING. THE CUSTOMER REPORTS REPEAT OBSERVATION OF DISCORDANT, ELEVATED ATELLICA IM TNIH RESULTS FOR AN OBSTETRIC PATIENT OVER A PERIOD OF SEVERAL MONTHS. DISCORDANT OBSERVATIONS WERE ASSOCIATED WITH MULTIPLE SAMPLE DRAWS, OVER A PERIOD BETWEEN (B)(6) 2024. THE CUSTOMER INDICATES THAT THE ELEVATED RESULTS (APPROXIMATELY 4,000 PG/ML) ARE REPRODUCIBLE ACROSS TWO LABORATORY LOCATIONS AND THREE DIFFERENT ATELLICA IM INSTRUMENTS. ONE RECENT SAMPLE WAS TESTED FOR TROPONIN I AND TROPONIN T USING ALTERNATE-METHOD TESTING AT AN EXTERNAL LAB, AND PRODUCED ¿NEGATIVE¿ RESULTS (BELOW REFERENCE CUTOFFS FOR THOSE ASSAYS). THE LOWER RESULTS WERE CONSIDERED CORRECT, AS THEY WERE CONSISTENT WITH THE PATIENT¿S CLINICAL PICTURE, WHERE NO CARDIAC ISSUES OR DISEASE HAVE BEEN IDENTIFIED. THE SERIES OF HIGH ATELLICA IM TNIH RESULTS HAS BEEN IDENTIFIED AS FALSELY ELEVATED. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112308 ↗
• MalfunctionJan 9, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS FOR ONE PATIENT WHICH WERE DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND ALTERNATE-METHOD TESTING. THE CUSTOMER REPORTS REPEAT OBSERVATION OF DISCORDANT, ELEVATED ATELLICA IM TNIH RESULTS FOR AN OBSTETRIC PATIENT OVER A PERIOD OF SEVERAL MONTHS. DISCORDANT OBSERVATIONS WERE ASSOCIATED WITH MULTIPLE SAMPLE DRAWS, OVER A PERIOD BETWEEN (B)(6) 2024. THE CUSTOMER INDICATES THAT THE ELEVATED RESULTS (APPROXIMATELY 4,000 PG/ML) ARE REPRODUCIBLE ACROSS TWO LABORATORY LOCATIONS AND THREE DIFFERENT ATELLICA IM INSTRUMENTS. ONE RECENT SAMPLE WAS TESTED FOR TROPONIN I AND TROPONIN T USING ALTERNATE-METHOD TESTING AT AN EXTERNAL LAB, AND PRODUCED ¿NEGATIVE¿ RESULTS (BELOW REFERENCE CUTOFFS FOR THOSE ASSAYS). THE LOWER RESULTS WERE CONSIDERED CORRECT, AS THEY WERE CONSISTENT WITH THE PATIENT¿S CLINICAL PICTURE, WHERE NO CARDIAC ISSUES OR DISEASE HAVE BEEN IDENTIFIED. THE SERIES OF HIGH ATELLICA IM TNIH RESULTS HAS BEEN IDENTIFIED AS FALSELY ELEVATED. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112293 ↗
• MalfunctionJan 9, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS FOR ONE PATIENT WHICH WERE DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND ALTERNATE-METHOD TESTING. THE CUSTOMER REPORTS REPEAT OBSERVATION OF DISCORDANT, ELEVATED ATELLICA IM TNIH RESULTS FOR AN OBSTETRIC PATIENT OVER A PERIOD OF SEVERAL MONTHS. DISCORDANT OBSERVATIONS WERE ASSOCIATED WITH MULTIPLE SAMPLE DRAWS, OVER A PERIOD BETWEEN (B)(6) 2024. THE CUSTOMER INDICATES THAT THE ELEVATED RESULTS (APPROXIMATELY 4,000 PG/ML) ARE REPRODUCIBLE ACROSS TWO LABORATORY LOCATIONS AND THREE DIFFERENT ATELLICA IM INSTRUMENTS. ONE RECENT SAMPLE WAS TESTED FOR TROPONIN I AND TROPONIN T USING ALTERNATE-METHOD TESTING AT AN EXTERNAL LAB, AND PRODUCED ¿NEGATIVE¿ RESULTS (BELOW REFERENCE CUTOFFS FOR THOSE ASSAYS). THE LOWER RESULTS WERE CONSIDERED CORRECT, AS THEY WERE CONSISTENT WITH THE PATIENT¿S CLINICAL PICTURE, WHERE NO CARDIAC ISSUES OR DISEASE HAVE BEEN IDENTIFIED. THE SERIES OF HIGH ATELLICA IM TNIH RESULTS HAS BEEN IDENTIFIED AS FALSELY ELEVATED. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112262 ↗
• MalfunctionJan 9, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS FOR ONE PATIENT WHICH WERE DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND ALTERNATE-METHOD TESTING. THE CUSTOMER REPORTS REPEAT OBSERVATION OF DISCORDANT, ELEVATED ATELLICA IM TNIH RESULTS FOR AN OBSTETRIC PATIENT OVER A PERIOD OF SEVERAL MONTHS. DISCORDANT OBSERVATIONS WERE ASSOCIATED WITH MULTIPLE SAMPLE DRAWS, OVER A PERIOD BETWEEN APRIL AND DECEMBER 2024. THE CUSTOMER INDICATES THAT THE ELEVATED RESULTS (APPROXIMATELY 4,000 PG/ML) ARE REPRODUCIBLE ACROSS TWO LABORATORY LOCATIONS AND THREE DIFFERENT ATELLICA IM INSTRUMENTS. ONE RECENT SAMPLE WAS TESTED FOR TROPONIN I AND TROPONIN T USING ALTERNATE-METHOD TESTING AT AN EXTERNAL LAB AND PRODUCED ¿NEGATIVE¿ RESULTS (BELOW REFERENCE CUTOFFS FOR THOSE ASSAYS). THE LOWER RESULTS WERE CONSIDERED CORRECT, AS THEY WERE CONSISTENT WITH THE PATIENT¿S CLINICAL PICTURE, WHERE NO CARDIAC ISSUES OR DISEASE HAVE BEEN IDENTIFIED. THE SERIES OF HIGH ATELLICA IM TNIH RESULTS HAS BEEN IDENTIFIED AS FALSELY ELEVATED. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21111547 ↗