ADVIA Centaur TNIH 100T Kit 10994774Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00630414602912), received between Apr 19, 2019 and May 11, 2026 — classified as 67 malfunctions.

The most frequently reported specific device problem is “High Test Results” (43 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 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026High Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUSLY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT ON A PATIENT SAMPLE WAS OBTAINED ON THE ADVIA CENTAUR CP INSTRUMENT. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS TESTED TWICE ON SAME ADVIA CENTAUR CP INSTRUMENT. BOTH THE RESULTS OBTAINED WERE LOWER, SIMILAR AND CONSIDERED CORRECT. THE REPEAT RESULT OF 54.48 NG/L WAS REPORTED AS CORRECT RESULT TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTIONS DUE TO THE ELEVATED TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136363 ↗
• MalfunctionMay 8, 2026High Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUSLY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT ON A PATIENT SAMPLE WAS OBTAINED ON THE ADVIA CENTAUR CP INSTRUMENT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN AND WAS NOT QUESTIONED. A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND TESTED ON SAME ADVIA CENTAUR CP INSTRUMENT. THE RESULT OBTAINED WAS LOWER. AGAIN, THE INITIAL SAMPLE WAS REPEATED ON THE ORIGINAL INSTRUMENT AND SIMILAR LOW RESULT WAS OBTAINED. BOTH THE RESULTS WERE SAME AND CONSIDERED CORRECT. THIS REPEAT RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTIONS DUE TO ELEVATED TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25121811 ↗
• 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 ADVIA CENTAUR CP INSTRUMENT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN AND WAS NOT QUESTIONED. A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND TESTED ON SAME ADVIA CENTAUR CP INSTRUMENT. THE RESULT OBTAINED WAS LOWER. AGAIN, THE INITIAL SAMPLE WAS REPEATED ON THE ORIGINAL INSTRUMENT AND SIMILAR LOWER RESULT WAS OBTAINED. BOTH THE RESULTS WERE SAME AND CONSIDERED CORRECT. THIS REPEAT RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTIONS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820203 ↗
• MalfunctionOct 21, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED ADVIA CENTAUR HIGH SENSITIVITY TROPONIN I (TNIH) RESULT VS REPEAT TESTING / ALTERNATE METHOD. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S) AND THE RESULT WAS QUESTIONED. THE PHYSICIAN QUESTIONED THE RESULT DUE TO THE PATIENT EXPERIENCING CHEST PAINS. THE PHYSICIAN ORDERED A SECOND DRAW 1-2 HOURS POST ORIGINAL DRAW, AND A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND PROCESSED ON THE SAME ANALYZER AND A LOWER RESULT WAS OBTAINED. THE ORIGINAL SAMPLE WAS REPEATED AGAIN ON THE SAME ANALYZER USING A NEW REAGENT PACK OF THE SAME LOT AND A LOWER RESULT WAS OBTAINED WHICH WAS CONSISTENT WITH THE NEW SAMPLE RESULT. THE ORIGINAL SAMPLE WAS REPEATED AGAIN ON A NON-SIEMENS ANALYZER AND OBTAINED A LOWER RESULT. A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND PROCESSED ON THE SAME ANALYZER AND A LOWER RESULT WAS OBTAINED. THE LOWER RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350902 ↗
• MalfunctionApr 17, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED AN ELEVATED ADVIA CENTAUR HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING TNIH LOT 108. AN INITIAL HIGHLY ELEVATED ADVIA CENTAUR TNIH RESULT WAS OBSERVED FOR A 52-YEAR-OLD MALE PATIENT WHO HAD BEEN ADMITTED WITH POTENTIAL CARDIAC SYMPTOMS. A SECOND SAMPLE WAS COLLECTED AND TESTED, AND A MUCH LOWER RESULT (BELOW REFERENCE THRESHOLD) WAS OBTAINED. WHEN THE ORIGINAL SAMPLE WAS RE-TESTED, A SIMILAR LOW RESULT WAS PRODUCED. THE LOWER RESULTS WERE ACCEPTED AS CORRECTED. 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 21854360 ↗
• MalfunctionFeb 24, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS AN OBSERVATION OF AN ELEVATED ADVIA CENTAUR HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. AN INITIAL HIGH SENSITIVITY TROPONIN I (TNIH) RESULT WAS OBTAINED FOR ONE OF THE PATIENTS IN QUESTION. PER THE ASSAY¿S INSTRUCTIONS FOR USE (IFU), A NEW SAMPLE WAS DRAWN AN HOUR LATER FROM THE SAME PATIENT AND PROCESSED ON THE ORIGINAL INSTRUMENT WHICH PRODUCED AN UNEXPECTEDLY ELEVATED RESULT. THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S) BUT WAS NOT QUESTIONED. THE ELEVATED RESULT WAS CONSIDERED DISCORDANT BY THE CUSTOMER. THEREFORE, THE SAME SAMPLE WAS REPROCESSED WHICH PRODUCED A RESULT SIMILAR TO THE INITIAL RESULT. THE LOWER RESULT WAS CONSIDERED CORRECT, AND A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN(S). 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 21444427 ↗
• MalfunctionJan 16, 2025Low Test Results; Low Test Results

  A CUSTOMER OBSERVED ELEVATED ADVIA CENTAUR HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS FOR SIX PATIENTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING TNIH LOT 108. THE CUSTOMER IDENTIFIED DISCORDANCE IN ADVIA CENTAUR TNIH RESULTS FOR SIX PATIENTS, WHERE INITIAL RESULTS WERE CONSIDERED FALSELY ELEVATED VS. REPEAT-TESTING RESULTS OBTAINED USING A SECOND ADVIA CENTAUR SYSTEM. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21170319 ↗
• MalfunctionDec 3, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ADVIA CENTAUR HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING ON AN ALTERNATE METHOD WHEN USING REAGENT LOT# 107. INITIAL ELEVATED RESULTS WERE OBTAINED FOR FOUR PATIENT SAMPLES. THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE METHOD AND OBTAINED LOWER RESULTS. THESE LOWER RESULTS WERE CONSIDERED CORRECT AND CORRECTED REPORTS WERE ISSUED TO THE PHYSICIAN(S). A CORRECTED REPORT WAS ISSUED. QUALITY CONTROL (QC) RESULTS WERE WITHIN THE ESTABLISHED RANGES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20830762 ↗
• MalfunctionMay 16, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A DEPRESSED ADVIA CENTAUR HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. THE INITIAL DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEAT-TESTED, AND A MUCH HIGHER RESULT WAS OBTAINED; THIS HIGHER RESULT WAS CONSIDERED CONSISTENT WITH PATIENT CONDITION AND ACCEPTED AS CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DEPRESSED TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19334582 ↗
• MalfunctionMay 1, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS AN OBSERVATION OF DISCORDANT ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT OBTAINED ON ONE PATIENT SAMPLE WHICH WAS CONSIDERED DISCORDANT RELATIVE TO REPEAT TESTING WHICH PRODUCED LOWER RESULTS WHEN PROCESSED ON AN ADVIA CENTAUR CP ANALYZER. THE CUSTOMER TESTED THE INITIAL BASELINE SAMPLE AND OBTAINED AN ELEVATED RESULT. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. PER LABORATORY PROTOCOL, AFTER AN HOUR A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND TESTED ON THE ORIGINAL INSTRUMENT AND OBTAINED A LOWER RESULT. THE BASELINE SAMPLE WAS ALSO RETESTED ON THE ORIGINAL INSTRUMENT AND OBTAINED A LOWER RESULT WHICH WAS CONSIDERED CORRECT SINCE IT MATCHED THE RESULT OF 1 HOUR COLLECTION TNIH PROTOCOL SAMPLE. A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN BASED ON REPEAT TESTING. THE CUSTOMER STATED THAT THERE WERE NO REPORTS OF ANY UNNECESSARY TREATMENT OR DELAY IN TREATMENT DUE TO THE ELEVATED RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19221362 ↗
• MalfunctionFeb 19, 2024High Test Results; High Test Results

  THE CUSTOMER OBTAINED ELEVATED ADVIA CENTAUR HIGH-SENSITIVITY TROPONIN I (TNLH) RESULTS ON 3 PATIENT SAMPLES WITH LOT 093 ON AN ADVIA CENTAUR XP INSTRUMENT. THE RESULTS WERE DISCORDANT COMPARED TO RETEST RESULTS WHEN THE SAME SAMPLES WERE RETESTED ON THE SAME INSTRUMENT USING A DIFFERENT REAGENT PACK. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE PATIENTS WERE HELD MORE TIME IN EMERGENCY DEPARTMENT FOR ADDITIONAL TROPONIN TESTS AND ECG. CORRECTED REPORTS WERE ISSUED. 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 18735910 ↗
• MalfunctionJan 24, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED A DISCORDANT ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT THAT WAS OBTAINED ON ONE PATIENT SAMPLE WHEN PROCESSED ON AN ADVIA CENTAUR XP INSTRUMENT. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN. AS PER THE CLINICAL SERIAL DOSING PROTOCOL, A NEW SAMPLE WAS DRAWN AND TESTED ON THE SAME INSTRUMENT WHICH OBTAINED A LOWER RESULT. THE LOWER RESULT WAS ALSO REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULTS. BOTH SAMPLES WERE RETESTED ON AN ALTERNATE ADVIA CENTAUR XP INSTRUMENT AND OBTAINED LOWER RESULTS. THE INITIAL SAMPLE WAS RETESTED ON THE ORIGINAL INSTRUMENT AND OBTAINED A LOWER RESULT. THIS RESULT WAS CONSIDERED CORRECT AND ISSUED ON THE CORRECTED REPORT SINCE IT WAS CONSISTENT WITH THE CLINICAL DATA AND ECG (ELECTROCARDIOGRAM) RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18576428 ↗
• MalfunctionNov 3, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ADVIA CENTAUR HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. TNIH KIT LOT 091 WAS IN USE AT THE TIME OF THE OBSERVATION. AN INITIAL ELEVATED TNIH RESULT OF 39.71 NG/L (JUST ABOVE APPLICABLE REFERENCE THRESHOLD OF 36.99 NG/L) WAS OBTAINED. THIS RESULT WAS QUESTIONED BY THE PHYSICIAN. THE PATIENT WAS KEPT UNDER OBSERVATION IN THE EMERGENCY ROOM AND A SECOND SAMPLE WAS DRAWN AND TESTED. THE SECOND SAMPLE PRODUCED A LOW RESULT (<2.50 NG/L), WHICH WAS ACCEPTED AS CORRECT. BOTH SAMPLES FROM THIS PATIENT WERE RE-TESTED FOLLOWING CENTRIFUGATION. THE INITIAL ELEVATED RESULT WAS NOT REPRODUCED, AS REPEAT TESTS FOR BOTH SAMPLES PRODUCED RESULTS <2.50 NG/L. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066910 ↗
• MalfunctionJul 11, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ADVIA CENTAUR CP HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT FOR ONE PATIENT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. AN INITIAL ELEVATED TNIH RESULT (ABOVE REFERENCE RANGE) WAS OBTAINED FOR A MALE PATIENT WITH HYPERTENSION IN THE EMERGENCY ROOM. ACCORDING TO HOSPITAL PROTOCOL, THE PATIENT WAS RE-DRAWN AND RE-TESTED TWO HOURS LATER, AND A LOWER RESULT (WITHIN REFERENCE RANGE) WAS PRODUCED. THE INITIAL SAMPLE WAS RECENTRIFUGED AND REPEAT-TESTED, AND A SIMILAR LOW RESULT WAS OBTAINED FROM THIS SAMPLE, AS WELL. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE LOWER RESULT WAS ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM OR ANY OTHER ADVERSE CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302301 ↗
• MalfunctionJun 27, 2023High Test Results; High Test Results

  A FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WAS OBTAINED ON A SECOND DRAW SAMPLE FROM A PATIENT ON AN ADVIA CENTAUR CP SYSTEM WHICH WAS CONSIDERED DISCORDANT WITH THE LOWER RESULT FROM A PRIOR SAMPLE DRAW AND SUBSEQUENT SAMPLE DRAWS. THE SECOND DRAW SAMPLE WAS REPEATED, AND THE RESULTS WERE LOWER AND IN LINE WITH THE OTHER DRAWS. IT IS UNKNOWN IF THE FALSELY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210471 ↗
• MalfunctionOct 12, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED ADVIA CENTAUR HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS ON TWO SAMPLES FROM THE SAME PATIENT. THE SAME SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULTS WERE LOWER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN, WHO DID NOT QUESTION THE RESULT. THERE WERE NO REPORTS THAT TREATMENT WAS ALTERED OR POSTPONED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED ADVIA CENTAUR TNIH RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15589186 ↗
• MalfunctionOct 12, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED ADVIA CENTAUR HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS ON TWO SAMPLES FROM THE SAME PATIENT. THE SAME SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULTS WERE LOWER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN, WHO DID NOT QUESTION THE RESULT. THERE WERE NO REPORTS THAT TREATMENT WAS ALTERED OR POSTPONED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED ADVIA CENTAUR TNIH RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15586465 ↗
• MalfunctionSep 30, 2022High Test Results; High Test Results

  THE CUSTOMER OBTAINED DISCORDANT ELEVATED ADVIA CENTAUR CP HIGH-SENSITIVITY TROPONIN I (TNIH), LOT 075 RESULTS ON TWO SAMPLES FROM THE SAME PATIENT. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULTS. ONE OF THE SAMPLES WAS REMEASURED ON AN ALTERNATE METHOD AND THE RESULT WAS NEGATIVE. BOTH OF THE SAMPLES WERE ALSO REPEATED ON THE ADVIA CENTAUR CP AND THE RESULTS WERE LOWER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED TNIH RESULTS..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15513562 ↗
• MalfunctionApr 29, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED AN ELEVATED INITIAL PATIENT RESULT WHEN USING THE ADVIA CENTAUR XPT HIGH-SENSITIVITY TROPONIN I (TNIH) ASSAY WHEN COMPARED TO REPEAT TESTING OF THE SAMPLE ON THE SAME SYSTEM. THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN AND THE RESULT WAS NOT QUESTIONED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED DISCORDANT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14254860 ↗
• MalfunctionNov 23, 2021High Test Results; High Test Results

  CUSTOMER OBSERVED AN ELEVATED ADVIA CENTAUR XP HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT FROM A SAMPLE THAT WAS CONSIDERED DISCORDANT WITH THE REPEAT RESULT OF THE SAMPLE AFTER RECENTRIFUGING AND ON REDRAW OF THE PATIENT. THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO AN ELEVATED TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12862241 ↗
• MalfunctionOct 18, 2021High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED ADVIA CENTAUR XPT HIGH-SENSITIVITY TROPONIN I (TNIH) LABORATORY RESULTS WERE OBTAINED ON A PATIENT. THE CUSTOMER PERFORMED REPEAT TNIH TESTING THE SAME DAY AND FOLLOWING DAY ON THE SAME SAMPLE AND SAME INSTRUMENT, RESULTING HIGH. THE PATIENT SAMPLE WAS TESTED AT A PARTNER LABORATORY WITH AN ALTERNATE TROPONIN (TNT) TEST METHOD, RESULTING LOWER. A NEW SAMPLE DRAW WAS TAKEN APPROXIMATELY ONE WEEK LATER FROM THE SAME PATIENT, RUN ON THE SAME ADVIA CENTAUR XPT, RESULTING HIGH. THE ALTERNATE TROPONIN (TNT) RESULT WAS REPORTED TO THE PHYSICIAN AS THE CORRECT RESULT. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ADVIA CENTAUR XPT HIGH- SENSITIVITY TROPONIN I (TNIH) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12651867 ↗
• MalfunctionOct 18, 2021High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED ADVIA CENTAUR XPT HIGH-SENSITIVITY TROPONIN I (TNIH) LABORATORY RESULTS WERE OBTAINED ON A PATIENT. THE CUSTOMER PERFORMED REPEAT TNIH TESTING THE SAME DAY AND FOLLOWING DAY ON THE SAME SAMPLE AND SAME INSTRUMENT, RESULTING HIGH. THE PATIENT SAMPLE WAS TESTED AT A PARTNER LABORATORY WITH AN ALTERNATE TROPONIN (TNT) TEST METHOD, RESULTING LOWER. A NEW SAMPLE DRAW WAS TAKEN APPROXIMATELY ONE WEEK LATER FROM THE SAME PATIENT, RUN ON THE SAME ADVIA CENTAUR XPT, RESULTING HIGH. THE ALTERNATE TROPONIN (TNT) RESULT WAS REPORTED TO THE PHYSICIAN AS THE CORRECT RESULT. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ADVIA CENTAUR XPT HIGH- SENSITIVITY TROPONIN I (TNIH) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12651819 ↗
• MalfunctionOct 18, 2021High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED ADVIA CENTAUR XPT HIGH-SENSITIVITY TROPONIN I (TNIH) LABORATORY RESULTS WERE OBTAINED ON A PATIENT. THE CUSTOMER PERFORMED REPEAT TNIH TESTING THE SAME DAY AND FOLLOWING DAY ON THE SAME SAMPLE AND SAME INSTRUMENT, RESULTING HIGH. THE PATIENT SAMPLE WAS TESTED AT A PARTNER LABORATORY WITH AN ALTERNATE TROPONIN (TNT) TEST METHOD, RESULTING LOWER. A NEW SAMPLE DRAW WAS TAKEN APPROXIMATELY ONE WEEK LATER FROM THE SAME PATIENT, RUN ON THE SAME ADVIA CENTAUR XPT, RESULTING HIGH. THE ALTERNATE TROPONIN (TNT) RESULT WAS REPORTED TO THE PHYSICIAN AS THE CORRECT RESULT. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ADVIA CENTAUR XPT HIGH- SENSITIVITY TROPONIN I (TNIH) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12651720 ↗
• MalfunctionOct 11, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED DISCORDANT PATIENT RESULTS WHEN USING THE ADVIA CENTAUR XPT HIGH-SENSITIVITY TROPONIN I (TNIH) ASSAY WHEN COMPARED TO AN ALTERNATE METHOD. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN AND THE RESULTS WERE NOT QUESTIONED. THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT FOR ADDITIONAL TESTING. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12608323 ↗
• MalfunctionJun 15, 2021High Test Results; High Test Results

  A CUSTOMER OBTAINED AN ELEVATED ADVIA CENTAUR XP HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT FROM ONE PATIENT SAMPLE FROM A CLINICAL TRIAL STUDY. THE ELEVATED RESULT WAS REPORTED TO AND QUESTIONED BY THE CLINICAL TRIAL COORDINATOR. THE SAMPLE WAS REPEATED ON A DIFFERENT DAY AND SIMILAR ELEVATED RESULTS WERE OBTAINED. ALTHOUGH THE CUSTOMER COULD NOT PROVIDE AN EXPECTED VALUE OR TRUE RESULT FOR THIS PATIENT FOR COMPARISON, THE CLINICAL TRIAL COORDINATOR BELIEVED THE RESULTS TO BE FALSELY ELEVATED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED TNIH RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12005131 ↗