ADVIA Centaur TnI-UltraRecalls & reported problems across all models

We found 2 models of ADVIA Centaur TnI-Ultra by Siemens Healthcare Diagnostics Inc. in the FDA's device registry (GUDID). Together they are named in 81 adverse event reports in the FDA's MAUDE database, received between Jun 29, 2017 and Dec 30, 2021 — classified as 81 malfunctions.

The most frequently reported specific device problem is “High Test Results” (7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ADVIA Centaur TnI-Ultra problems

ADVIA Centaur TnI-Ultra models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ADVIA Centaur® TnI-Ultra™ 10317708

  IMMUNOASSAY METHOD, TROPONIN SUBUNIT
  45 reports
• ADVIA Centaur® TnI-Ultra™ 10317709

  IMMUNOASSAY METHOD, TROPONIN SUBUNIT
  36 reports

Recent ADVIA Centaur TnI-Ultra adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED ADVIA CENTAUR XP TROPONIN-I ULTRA (TNI-ULTRA) RESULTS FOR FIVE PATIENT SAMPLES THAT WERE DISCORDANT COMPARED TO REPEAT TESTING ON A FRESHLY OPENED REAGENT PACK. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP TNI-ULTRA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13119494 ↗
• MalfunctionJul 13, 2021High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED ADVIA CENTAUR XP TNI-ULTRA RESULTS WERE OBTAINED ON FIVE PATIENTS. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER OBSERVED THAT THERE WERE NO REMAINING TESTS AVAILABLE TO PERFORM REPEAT TESTING WITH THE SAME REAGENT READYPACK. THE SAME PATIENT SAMPLES WERE REPEATED WITH A NEW REAGENT READYPACK FROM THE SAME REAGENT LOT, ALL RESULTING LOWER. THE LOWER RESULTS WERE REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULTS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ADVIA CENTAUR XP TNI-ULTRA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160841 ↗
• MalfunctionMar 19, 2021High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED ADVIA CENTAUR TNI-ULTRA ASSAY RESULT WAS OBTAINED ON A PATIENT SAMPLE AND QUESTIONED BY THE PHYSICIAN(S). THE CUSTOMER PERFORMED REPEAT TESTING ON THE SAME SAMPLE AFTER CENTRIFUGATION, RESULTING HIGH. THE SAME SAMPLE WAS TESTED ON TWO ALTERNATE TROPONIN TEST METHODS, RESULTING LOWER. THE LOWER RESULT AGREED WITH WHAT WAS EXPECTED. THE LOWER RESULT WAS REPORTED TO THE PHYSICIAN(S) AS A CORRECTED RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ADVIA CENTAUR TNI-ULTRA ASSAY RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11529919 ↗
• MalfunctionNov 10, 2020High Test Results; High Test Results

  A DISCORDANT HIGH RESULT WAS OBSERVED FOR ONE PATIENT WHEN USING THE ADVIA CENTAUR XP TROPONIN I ULTRA (TNI-ULTRA) ASSAY. THE INITIAL RESULT WAS POSITIVE; REPEAT TESTING USING THE SAME INSTRUMENT, ASSAY, AND REAGENT PACK PRODUCED A NEGATIVE RESULT. ADDITIONAL TESTING USING THE BECKMAN COULTER UNICEL DXI 800 SYSTEM ALSO PRODUCED A NEGATIVE RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY-ELEVATED ADVIA CENTAUR XP TROPONIN I ULTRA (TNI-ULTRA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10817808 ↗
• MalfunctionOct 1, 2020High Test Results; High Test Results

  ON (B)(6) 2020, A DISCORDANT, FALSELY-ELEVATED ADVIA CENTAUR XP TROPONIN I ULTRA (TNI-ULTRA) RESULT WAS OBSERVED FOR ONE PATIENT SAMPLE. THE SAME SAMPLE WAS RE-TESTED TWICE ON THE SAME SYSTEM. PRODUCING REPRODUCIBLY LOWER RESULTS. THE REPEAT TNI-ULTRA RESULTS WERE REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULTS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY-ELEVATED ADVIA CENTAUR XP TROPONIN I ULTRA (TNI-ULTRA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10613340 ↗
• MalfunctionAug 21, 2020High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED ADVIA CENTAUR XP TROPONIN I ULTRA (TNI-ULTRA) INITIAL RESULTS WERE OBTAINED ON FOUR PATIENT SAMPLES. THE CUSTOMER PERFORMED REPEAT TNI-ULTRA TESTING ON THE SAME SAMPLES WITH A NEW REAGENT READYPACK FROM THE SAME REAGENT LOT NUMBER, RESULTING LOWER. THE REPEAT TNI-ULTRA RESULTS WERE REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULTS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ADVIA CENTAUR XP TROPONIN I ULTRA (TNI-ULTRA) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10438024 ↗
• MalfunctionJun 5, 2020High Test Results; High Test Results

  A CUSTOMER OBSERVED A DISCORDANT HIGH RESULT FOR TWO DIFFERENT PATIENTS USING ADVIA CENTAUR CP TNI ULTRA. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE EMERGENCY ROOM PHYSICIAN(S). THE LABORATORY TECHNICIAN(S) RETESTED THE SAMPLE AND NEGATIVE RESULTS (<0.02 NG/ML) WERE OBSERVED, AS EXPECTED. THE RETEST RESULTS WERE REPORTED TO THE PHYSICIAN(S). TWO ADDITIONAL DRAWS WERE TAKEN FROM EACH PATIENT AND NEGATIVE RESULTS WERE AGAIN OBSERVED. SAMPLE DRAW TIMES WERE NOT PROVIDED. SST TIGER TOP SAMPLE TUBES WERE USED FOR SAMPLE COLLECTION. QUALITY CONTROL WAS IN RANGE. THE SAME INSTRUMENT WAS USED TO TEST ALL SAMPLES. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED BASED ON THE TNI ULTRA RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI ULTRA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10125450 ↗
• MalfunctionDec 23, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER OBSERVED MULTIPLE FALSELY ELEVATED ADVIA CENTAUR XP TNI ULTRA RESULTS ON (B)(6) 2019 ON ONE INSTRUMENT WITH ONE REAGENT READYPACK. QUALITY CONTROL (QC) WAS WITHIN THE CUSTOMER RANGE ON (B)(6) 2019 PRIOR TO RUNNING PATIENT SAMPLES. QC WAS HIGH OUT OF THE CUSTOMER RANGE THE NEXT MORNING (B)(6) 2019 AFTER PATIENT SAMPLES WERE RUN. THIS ALERTED THE CUSTOMER OF THE ISSUE AND THE PATIENT SAMPLES WERE REPEATED. THE REPEATED RESULTS WERE ALL LOWER THAN THE INITIAL RESULTS. CORRECTED REPORTS WERE ISSUED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE INITIAL ELEVATED TNI ULTRA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9513082 ↗
• MalfunctionDec 13, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE POSITIVE ADVIA CENTAUR XP TROPONIN ULTRA (TNI-ULTRA) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS POSITIVE. THE POSITIVE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT SAMPLE WAS TREATED WITH PEG (POLYETHYLENE GLYCOL 6000) AND THE RESULT WAS LOWER. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS WITHIN THE NORMAL REFERENCE RANGE. THE RESULT WAS ACCEPTED BY THE PHYSICIAN AS IT MATCHED THE CLINICAL PICTURE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9467881 ↗
• MalfunctionDec 13, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE POSITIVE ADVIA CENTAUR XP TROPONIN ULTRA (TNI-ULTRA) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS POSITIVE. THE POSITIVE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT SAMPLE WAS TREATED WITH PEG (POLYETHYLENE GLYCOL 6000) AND THE RESULT WAS LOWER. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS WITHIN THE NORMAL REFERENCE RANGE. THE RESULT WAS ACCEPTED BY THE PHYSICIAN AS IT MATCHED THE CLINICAL PICTURE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9467865 ↗
• MalfunctionJun 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT HIGH ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) RESULTS WERE OBTAINED FOR SAMPLES FROM FIVE PATIENTS DURING A LOT TO LOT CORRELATION. THE CORRELATION WAS BETWEEN TNI-ULTRA LOT 149 AND LOT 160. THE RESULTS WERE HIGHER WITH LOT 160. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8740919 ↗
• MalfunctionJun 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSELY ELEVATED ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS NEGATIVE. THE PATIENT SAMPLE WAS TESTED ON THE ALTERNATE SYSTEM AND THE RESULT WAS NEGATIVE. A NEW SAMPLE WAS TESTED, AND THE RESULT WAS NEGATIVE. A CORRECTED REPORT WAS ISSUED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8698141 ↗
• MalfunctionJun 5, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  A CUSTOMER OBTAINED DISCORDANT LOW RESULTS (NEGATIVE) FOR ONE PATIENT ((B)(6) WITH THE ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) ASSAY VERSUS ALTERNATE METHODS. THE INITIAL ADVIA CENTAUR CP TNI-ULTRA RESULTS WERE REPORTED AND QUESTIONED BY PHYSICIAN. QUALITY CONTROL RESULTS WERE IN RANGE. A SECOND ALIQUOT FROM THE SAME PATIENT WAS TESTED WITH ADVIA CENTAUR CP TNIULTRA, ADVIA CENTAUR XP TNI-ULTRA AND (3) ALTERNATE METHODS. THE CUSTOMER BELIEVES THAT THE ADVIA CENTAUR SYSTEMS TNIULTRA LOW RESULTS TO BE DISCORDANT AND THE ALTERNATE METHOD RESULTS TO BE CORRECT. A CORRECTED REPORT WAS RELEASED. IN ADDITION, ADDITIONAL PATIENT SAMPLE ((B)(6)) WAS TESTED FOR COMPARISON ONLY BETWEEN ADVIA CENTAUR CP TNI ULTRA, ADVIA CENTAUR XP TNI-ULTRA AND ALTERNATE METHODS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8672674 ↗
• MalfunctionJun 5, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  A CUSTOMER OBTAINED DISCORDANT LOW RESULTS (NEGATIVE) FOR ONE PATIENT (SID (B)(6)) WITH THE ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) ASSAY VERSUS ALTERNATE METHODS. THE INITIAL ADVIA CENTAUR CP TNI-ULTRA RESULTS WERE REPORTED AND QUESTIONED BY PHYSICIAN. QUALITY CONTROL RESULTS WERE IN RANGE. A SECOND ALIQUOT FROM THE SAME PATIENT WAS TESTED WITH ADVIA CENTAUR CP TNIULTRA, ADVIA CENTAUR XP TNI-ULTRA AND (3) ALTERNATE METHODS. THE CUSTOMER BELIEVES THAT THE ADVIA CENTAUR SYSTEMS TNI-ULTRA LOW RESULTS TO BE DISCORDANT AND THE ALTERNATE METHOD RESULTS TO BE CORRECT. A CORRECTED REPORT WAS RELEASED. IN ADDITION, ADDITIONAL PATIENT SAMPLE (SID (B)(6)) WAS TESTED FOR COMPARISON ONLY BETWEEN ADVIA CENTAUR CP TNI ULTRA, ADVIA CENTAUR XP TNI-ULTRA AND ALTERNATE METHODS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8672673 ↗
• MalfunctionJun 5, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  A CUSTOMER OBTAINED DISCORDANT LOW RESULTS (NEGATIVE) FOR ONE PATIENT ((B)(6)) WITH THE ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) ASSAY VERSUS ALTERNATE METHODS. THE INITIAL ADVIA CENTAUR CP TNI-ULTRA RESULTS WERE REPORTED AND QUESTIONED BY PHYSICIAN. QUALITY CONTROL RESULTS WERE IN RANGE. A SECOND ALIQUOT FROM THE SAME PATIENT WAS TESTED WITH ADVIA CENTAUR CP TNIULTRA, ADVIA CENTAUR XP TNI-ULTRA AND (3) ALTERNATE METHODS. THE CUSTOMER BELIEVES THAT THE ADVIA CENTAUR SYSTEMS TNIULTRA LOW RESULTS TO BE DISCORDANT AND THE ALTERNATE METHOD RESULTS TO BE CORRECT. A CORRECTED REPORT WAS RELEASED. IN ADDITION, ADDITIONAL PATIENT SAMPLE ((B)(6)) WAS TESTED FOR COMPARISON ONLY BETWEEN ADVIA CENTAUR CP TNI ULTRA, ADVIA CENTAUR XP TNI-ULTRA AND ALTERNATE METHODS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8672672 ↗

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