Atellica IM TNIH 10997840Recalls & reported problems

Summary

The FDA's MAUDE database contains 166 adverse event reports that list this exact device (DI 00630414006703), received between Aug 9, 2019 and Sep 17, 2026 — classified as 166 malfunctions.

The most frequently reported specific device problem is “High Test Results” (136 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 166 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810360 ↗
• MalfunctionMay 15, 2026High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING LOT# 113. INITIAL ELEVATED RESULTS WERE OBTAINED FOR THREE PATIENT SAMPLES FROM THE EMERGENCY ROOM (ER) DEPARTMENT. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE ANALYZER WHICH PRODUCED LOWER RESULTS. THE LOWER RESULTS WERE CONSIDERED CORRECT AND CORRECTED REPORTS WERE ISSUED 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 25187294 ↗
• MalfunctionMay 12, 2026High Test Results

  THE CUSTOMER OBSERVED THAT ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNIH) LOT 113 RESULTS FOR A PATIENT DID NOT DECREASE OVER TIME AS EXPECTED FOR A PATIENT WHO WAS DIAGNOSED AND TREATED FOR ACUTE MYOCARDIAL INFARCTION (AMI). ALTERNATE METHOD RESULTS FOR THIS PATIENT ARE LOWER, BUT STILL ABOVE THE METHOD REFERENCE RANGE/CUTOFF. THE PATIENT WAS CORRECTLY DIAGNOSED AND TREATED, BUT THE ATELLICA IM TNIH RESULTS ARE NOT DROPPING ACROSS MULTIPLE DAYS OF TESTING. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150548 ↗
• MalfunctionMay 12, 2026High Test Results

  THE CUSTOMER OBSERVED THAT ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNIH) LOT 113 RESULTS FOR A PATIENT DID NOT DECREASE OVER TIME AS EXPECTED FOR A PATIENT WHO WAS DIAGNOSED AND TREATED FOR ACUTE MYOCARDIAL INFARCTION (AMI). ALTERNATE METHOD RESULTS FOR THIS PATIENT ARE LOWER, BUT STILL ABOVE THE METHOD REFERENCE RANGE/CUTOFF. THE PATIENT WAS CORRECTLY DIAGNOSED AND TREATED, BUT THE ATELLICA IM TNIH RESULTS ARE NOT DROPPING ACROSS MULTIPLE DAYS OF TESTING. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150547 ↗
• MalfunctionMay 12, 2026High Test Results

  THE CUSTOMER OBSERVED THAT ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNIH) LOT: 113 RESULTS FOR A PATIENT DID NOT DECREASE OVER TIME AS EXPECTED FOR A PATIENT WHO WAS DIAGNOSED AND TREATED FOR ACUTE MYOCARDIAL INFARCTION (AMI). ALTERNATE METHOD RESULTS FOR THIS PATIENT ARE LOWER, BUT STILL ABOVE THE METHOD REFERENCE RANGE/CUTOFF. THE PATIENT WAS CORRECTLY DIAGNOSED AND TREATED, BUT THE ATELLICA IM TNIH RESULTS ARE NOT DROPPING ACROSS MULTIPLE DAYS OF TESTING. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150546 ↗
• MalfunctionMay 12, 2026High Test Results

  THE CUSTOMER OBSERVED THAT ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNIH) LOT 113 RESULTS FOR A PATIENT DID NOT DECREASE OVER TIME AS EXPECTED FOR A PATIENT WHO WAS DIAGNOSED AND TREATED FOR ACUTE MYOCARDIAL INFARCTION (AMI). ALTERNATE METHOD RESULTS FOR THIS PATIENT ARE LOWER, BUT STILL ABOVE THE METHOD REFERENCE RANGE/CUTOFF. THE PATIENT WAS CORRECTLY DIAGNOSED AND TREATED, BUT THE ATELLICA IM TNIH RESULTS ARE NOT DROPPING ACROSS MULTIPLE DAYS OF TESTING. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150545 ↗
• MalfunctionMay 12, 2026High Test Results

  THE CUSTOMER OBSERVED THAT ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNIH) LOT 113 RESULTS FOR A PATIENT DID NOT DECREASE OVER TIME AS EXPECTED FOR A PATIENT WHO WAS DIAGNOSED AND TREATED FOR ACUTE MYOCARDIAL INFARCTION (AMI). ALTERNATE METHOD RESULTS FOR THIS PATIENT ARE LOWER, BUT STILL ABOVE THE METHOD REFERENCE RANGE/CUTOFF. THE PATIENT WAS CORRECTLY DIAGNOSED AND TREATED, BUT THE ATELLICA IM TNIH RESULTS ARE NOT DROPPING ACROSS MULTIPLE DAYS OF TESTING. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150544 ↗
• MalfunctionMay 12, 2026High Test Results

  THE CUSTOMER OBSERVED THAT ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNIH) LOT 113 RESULTS FOR A PATIENT DID NOT DECREASE OVER TIME AS EXPECTED FOR A PATIENT WHO WAS DIAGNOSED AND TREATED FOR ACUTE MYOCARDIAL INFARCTION (AMI). ALTERNATE METHOD RESULTS FOR THIS PATIENT ARE LOWER, BUT STILL ABOVE THE METHOD REFERENCE RANGE/CUTOFF. THE PATIENT WAS CORRECTLY DIAGNOSED AND TREATED, BUT THE ATELLICA IM TNIH RESULTS ARE NOT DROPPING ACROSS MULTIPLE DAYS OF TESTING. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150542 ↗
• MalfunctionMay 6, 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 114. AN INITIAL ELEVATED ATELLICA IM TNIH RESULT WAS OBSERVED FOR A 28-YEAR-OLD FEMALE PATIENT. NEW SAMPLES WERE DRAWN AND TESTED ON THE FOLLOWING TWO DAYS, AND EACH SAMPLE PRODUCED AN ELEVATED TNIH RESULT. THE PHYSICIAN QUESTIONED THESE ELEVATED RESULTS, AND THE PATIENT¿S SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING USING AN ALTERNATE METHOD (ROCHE). THE ALTERNATE-METHOD RESULT WAS MUCH LOWER (NEAR OR BELOW CUTOFF), AND CONSIDERED CONSISTENT WITH THE PATIENT¿S CLINICAL CONDITION. 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. NOTE: EACH OBSERVATION OF AN ERRONEOUS ATELLICA IM TNIH RESULT IS REPORTED SEPARATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094006 ↗
• MalfunctionMay 6, 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 114. AN INITIAL ELEVATED ATELLICA IM TNIH RESULT WAS OBSERVED FOR A 28-YEAR-OLD FEMALE PATIENT. NEW SAMPLES WERE DRAWN AND TESTED ON THE FOLLOWING TWO DAYS, AND EACH SAMPLE PRODUCED AN ELEVATED TNIH RESULT. THE PHYSICIAN QUESTIONED THESE ELEVATED RESULTS, AND THE PATIENT¿S SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING USING AN ALTERNATE METHOD (ROCHE). THE ALTERNATE-METHOD RESULT WAS MUCH LOWER (NEAR OR BELOW CUTOFF) AND CONSIDERED CONSISTENT WITH THE PATIENT¿S CLINICAL CONDITION. 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. NOTE: EACH OBSERVATION OF AN ERRONEOUS ATELLICA IM TNIH RESULT IS REPORTED SEPARATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094005 ↗
• MalfunctionMay 5, 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 114. AN ELEVATED ATELLICA IM TNIH RESULT WAS OBSERVED FOR AN 88-YEAR-OLD FEMALE PATIENT. THE PATIENT¿S SAMPLE WAS RE-TESTED USING AN ALTERNATE METHOD (AFIAS SYSTEM), WHICH PRODUCED A RESULT BELOW CUTOFF. THE INITIAL TNIH RESULT WAS IDENTIFIED AS FALSELY ELEVATED. WHEN THE SAMPLE WAS RE-TESTED FOR INVESTIGATION PURPOSES ON THE ATELLICA IM PLATFORM THREE DAYS LATER, IT AGAIN PRODUCED A SIMILARLY ELEVATED RESULT. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE. NO ISSUES WERE IDENTIFIED WITH QUALITY CONTROL (QC) RESULTS AT THE TIME OF THESE OBSERVATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25080219 ↗
• MalfunctionApr 8, 2026High Test Results

  THE CUSTOMER REPORTED AN ERRONEOUSLY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT ON A PATIENT SAMPLE WAS OBTAINED ON AN ATELLICA IM 1300 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE SAME SAMPLE WAS REPEATED ON THE ALTERNATE ATELLICA IM 1300 ANALYZER. THE RESULT OBTAINED WAS LOWER AND WAS AS EXPECTED. THIS REPEAT RESULT WAS REPORTED AS CORRECT RESULT TO THE PHYSICIAN. THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24813677 ↗
• MalfunctionMar 31, 2026High Test Results

  THE CUSTOMER REPORTED THAT THEY OBTAINED ERRONEOUSLY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT ON A PATIENT SAMPLE VS ALTERNATE METHOD ON AN ATELLICA IM 1300 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA IM 1600 ANALYZER FOR TROUBLESHOOTING PURPOSES AND THE RESULT WAS ELEVATED. THE SAMPLE WAS REPEATED ON TWO NON-SIEMENS METHODS/ANALYZERS, AND LOWER RESULTS WERE OBTAINED THAN THE INITIAL RESULTS. THE RESULTS FROM NON-SIEMENS METHODS/ANALYZERS WERE CONSISTENT WITH THE PATIENT¿S CLINICAL PICTURE AND CONSIDERED CORRECT. THE CORRECTED REPORT WAS ISSUED WITH THE RESULT OF 10.5 NG/L. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741590 ↗
• MalfunctionMar 31, 2026High Test Results

  THE CUSTOMER COMPLAINS OF FALSELY ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) LOT 114 RESULTS ON 3 SERUM SAMPLES FROM ONE PATIENT VS ALTERNATE METHOD AND CLINICAL OUTCOME (NO AMI). A 41-YEAR-OLD MALE PATIENT WHO PRESENTED AT THE CUSTOMER SITE ((B)(6) CENTER / EMERGENCY ROOM) WITH SYMPTOMS OF AMI. THE CUSTOMER LABORATORY OBTAINED AN ELEVATED (GREATER THAN REFERENCE RANGE) ATELLICA IM TNIH RESULT ON A SAMPLE FROM THE PATIENT. THE RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS RETESTED USING AN ALTERNATE METHOD (ISTAT) AND RESULT WAS ALSO GREATER THAN THE METHOD'S REFERENCE RANGE. THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE UNIVERSITY OF IOWA HEALTHCARE CENTER. TWO OTHER SERUM SAMPLES WERE DRAWN FROM THIS PATIENT AND TESTED WITH ATELLICA IM TNIH. THESE RESULTS WERE SIMILAR TO THE INITIAL ELEVATED RESULT. THE PHYSICIAN SENT THE PATIENT TO ANOTHER FACILITY FOR FURTHER EVALUATION AND TESTING WITH 2 OTHER ALTERNATE METHODS. THE ALTERNATE METHODS AT THIS NON-CUSTOMER SITE PRODUCED LOWER RESULT VALUES. ONE METHOD PRODUCED A RESULT GREATER THAN THE RESPECTIVE METHOD'S REFERENCE RANGE AND ONE METHOD PRODUCED A RESULT THAT WAS JUST BELOW THE METHOD'S REFERENCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24740936 ↗
• MalfunctionMar 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER COMPLAINS OF A DISCORDANCE BETWEEN NEAT AND DILUTED RESULTS ON A PATIENT SAMPLE TESTED WITH ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) LOT 113. A SAMPLE FROM A 21-MONTH-OLD MALE PATIENT WAS TESTED AND AN ELEVATED RESULT WAS OBTAINED. THE SAMPLE WAS SUBSEQUENTLY AUTODILUTED (X5) ON THE SAME ANALYZER AND THE RESULT WAS MUCH LOWER. TO CONFIRM, THE SAME SAMPLE WAS RETESTED UNDILUTED AND AUTODILUTED ON A DIFFERENT ATELLICA IM ANALYZER AND RESULTS WERE SIMILAR TO THE INITIAL RESULTS. THE COMPLAINT STATES THAT THE INITIAL RESULTS WERE REPORTED, BUT A CORRECTED REPORT WAS NOT ISSUED. IT IS UNKNOWN WHETHER THE ORDERING PHYSICIAN QUESTIONED THE RESULTS. THERE ARE NO ALLEGATIONS OF PATIENT HARM OR ADVERSE CONSEQUENCES IN ASSOCIATION WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665506 ↗
• MalfunctionMar 17, 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 115. AN ELEVATED ATELLICA IM TNIH RESULT WAS OBSERVED FOR THE PATIENT IN QUESTION. 48 HOURS LATER, THE CARDIOLOGY DEPARTMENT REPORTED THAT THIS RESULT WAS INCONSISTENT WITH THE PATIENT¿S CLINICAL PICTURE AND WITH LOWER SUBSEQUENT MEASUREMENTS. THE SAMPLE WAS RETRIEVED FROM STORAGE AND RE-TESTED USING TWO ATELLICA IM ANALYZERS, ULTIMATELY PRODUCING A RESULT OF <2.50 PG/ML (BELOW MEASUREMENT RANGE). 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 24615859 ↗
• MalfunctionJan 14, 2026High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING KIT LOT 112. AN INITIAL ELEVATED RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS THEN RETESTED ON THE ORIGINAL ANALYZER WHICH YIELDED A LOWER RESULT. THE LOWER RESULT WAS CONSIDERED CORRECT SINCE IT MATCHED THE PATIENT¿S CLINICAL HISTORY AND WAS REPORTED 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 24066852 ↗
• MalfunctionDec 17, 2025High Test Results; High 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 112. A FEMALE PATIENT REQUIRED TROPONIN MEASUREMENT WHILE THE LABORATORY¿S ATELLICA IM INSTRUMENT WAS UNDER REPAIR. THE TEST WAS PERFORMED USING A BIOMERIEUX MINIVIDAS SYSTEM, AND PRODUCED A NEGATIVE TROPONIN RESULT. THE PATIENT WAS RELEASED FOLLOWING THE NEGATIVE TROPONIN INDICATION. THE PATIENT¿S SAMPLE WAS REPEAT-TESTED USING ATELLICA IM TNIH, AND IT PRODUCED REPRODUCIBLY ELEVATED RESULTS (ABOVE CUTOFF FOR WOMEN). THE PATIENT WAS CALLED BACK FOLLOWING THE ELEVATED RESULTS, BUT THE PATIENT DID NOT CALL BACK OR RETURN TO THE PHYSICIAN¿S OFFICE. IT IS NOT KNOWN WHICH RESULTS ARE CORRECT FOR THIS PATIENT, BUT THERE IS NO INFORMATION INDICATING ANY PATIENT HARM. THE ELEVATED ATELLICA IM TNIH RESULTS ARE CONSERVATIVELY CONSIDERED TO BE POTENTIALLY FALSELY ELEVATED, ALTHOUGH THIS IS NOT KNOWN FOR CERTAIN. IT IS NOTED THAT QUALITY CONTROL (QC) RESULTS WERE WITHIN EXPECTED RANGES AT THE TIME OF THESE MEASUREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826893 ↗
• MalfunctionNov 20, 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 111. AN INITIAL ELEVATED TNIH RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION. THE PATIENT WAS CALLED AND ASKED TO GO TO THE EMERGENCY ROOM FOR FURTHER EVALUATION. THE SAMPLE WAS REPEAT-TESTED ON THE SAME ATELLICA IM INSTRUMENT, AND THE RESULT WAS MUCH LOWER (BELOW REFERENCE CUTOFF). WHEN THE SAME SAMPLE WAS TESTED LATER USING ROCHE COBAS, ANOTHER LOW RESULT WAS OBTAINED. THE INITIAL ELEVATED RESULT WAS IDENTIFIED AS DISCORDANT. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE. QUALITY CONTROL (QC) RESULTS WERE WITHIN EXPECTED RANGES AT THE TIME OF THE DISCORDANT OBSERVATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604322 ↗
• MalfunctionNov 6, 2025High Test Results; High Test Results

  THE CUSTOMER OBTAINED AN ELEVATED (>99TH PERCENTILE) ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) LOT 109 RESULT ON A SERUM SAMPLE FROM A PATIENT. THE ELEVATED RESULT WAS REPORTED. THE PHYSICIAN REFERRED THE PATIENT TO INTENSIVE CARE AND ANGIOGRAPHY PROCEDURE. A NEW SAMPLE WAS DRAWN FROM THE PATIENT, AND THE RESULT WAS LOWER (<99TH PERCENTILE). THE PATIENT IS IN GOOD CONDITION AND HAS BEEN DISCHARGED FROM HOSPITAL AND THERE IS NO ALLEGATION OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493926 ↗
• MalfunctionAug 13, 2025High Test Results; High Test Results

  THE CUSTOMER OBTAINED ELEVATED (>99TH PERCENTILE) ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) LOT: 108 RESULTS ON SERUM SAMPLES FROM A 40-YEAR-OLD FEMALE PATIENT WHO WAS SERIALLY TESTED. THE RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. THE RESULTS WERE CONSIDERED DISCORDANT BASED ON THE PATIENT CLINICAL HISTORY AND WERE EXPECTED TO BE LOW (<99TH PERCENTILE). THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792777 ↗
• MalfunctionAug 1, 2025High Test Results; High Test Results

  THE CUSTOMER OBTAINED AN ELEVATED (>99TH PERCENTILE) ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNIH) RESULT THAT WAS DISCORDANT RELATIVE TO A LOWER RETEST RESULT (<99TH PERCENTILE). THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME SAMPLE WAS TESTED ON A DIFFERENT ATELLICA IM ANALYZER, AND THE RESULT WAS LOWER AND CONSIDERED CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22688817 ↗
• MalfunctionJul 18, 2025High Test Results; High Test Results

  THE CUSTOMER OBTAINED AN ELEVATED (> 99TH PERCENTILE) ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNIH) LOT 110 RESULT THAT WAS DISCORDANT COMPARED TO THE LOW RESULT (< 99TH PERCENTILE) OBTAINED UPON RETESTING THE SAME SAMPLE ON THE SAME ANALYZER. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME SAMPLE WAS RETESTED ON THE SAME ANALYZER AND THE RESULT WAS LOWER. A NEW SAMPLE WAS DRAWN AND TESTED ON A DIFFERENT ANALYZER, AND THE RESULT WAS ALSO LOW AND CONSIDERED CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22545106 ↗
• MalfunctionMay 29, 2025High Test Results; High Test Results

  THE CUSTOMER OBTAINED AN ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT THAT WAS ELEVATED (>99TH PERCENTILE) RELATIVE TO A LOWER ALTERNATE-METHOD TESTING RESULT. THE INITIAL ELEVATED ATELLICA IM TNIH RESULT WAS REPORTED TO THE PHYSICIAN. SUBSEQUENTLY, THE PATIENT WENT TO AN EMERGENCY ROOM (ER) AND WAS TESTED WITH AN ALTERNATE METHOD AND A LOWER (¿NEGATIVE¿) TROPONIN RESULT WAS OBTAINED. THIS LOWER RESULT WAS CONSIDERED CORRECT. THERE IS NO ALLEGATION OF ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22111531 ↗
• MalfunctionMay 27, 2025High Test Results; High 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 109. AN ELEVATED ATELLICA IM TNIH RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION. THIS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS RE-TESTED USING AN ALTERNATE ATELLICA IM ANALYZER, AND THE ELEVATED RESULT WAS REPRODUCED. THE SAMPLE WAS SENT TO TWO OTHER LABORATORIES FOR ADDITIONAL TESTING. TWO ALTERNATE METHODS BOTH PRODUCED MUCH LOWER TROPONIN RESULTS, WHICH WERE CONSIDERED CONSISTENT WITH THE PATIENT¿S CLINICAL CONDITION. IT WAS NOTED THAT THIS PATIENT HAS HISTORICALLY PRODUCED ELEVATED TROPONIN RESULTS WHICH HAVE NOT BEEN CONSISTENT WITH THE CLINICAL PICTURE. 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 22086539 ↗