Access AccuTnI+3Recalls & reported problems across all models

We found 2 models of Access AccuTnI+3 by Beckman Coulter, Inc. in the FDA's device registry (GUDID). Together they are named in 165 adverse event reports in the FDA's MAUDE database, received between Sep 27, 2016 and Sep 30, 2026 — classified as 1 death, 122 injuries, 40 malfunctions.

The most frequently reported specific device problem is “High Test Results” (134 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 Access AccuTnI+3 problems

Access AccuTnI+3 models

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

• Access AccuTnI+3 A98143

  Immunoassay Method, Troponin Subunit
  1 death106 reports
• Access AccuTnI+3 A98264

  Immunoassay Method, Troponin Subunit
  59 reports

Recent Access AccuTnI+3 adverse event reports

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

• MalfunctionSep 30, 2026High Test Results

  The customer reported receiving an aspiration monitor detected possible obstruction error while testing a patient sample using the Access AccuTnI (TnIDx) assay ( Lot number 439439) on a DxI 600 instrument. Following the error, the sample was tested and generated an elevated troponin result of 4.410 ng/mL. Upon investigation, laboratory personnel identified a clot within the patient sample, which had been collected in a gold-top SST tube. There was no injury, death, delay in treatment, or change in diagnosis associated with this event, and no samples were compromised.The laboratory removed the clot from the specimen and repeated the analysis. The repeat result was 1.229 ng/mL, which the customer confirmed was consistent with the patient's previously known elevated troponin levels. The customer indicated that no elevated results were reported and that the sample itself was the source of the issue. The customer also noted that quality control results were within established ranges and reported no instrument performance concerns other than the aspiration obstruction error.Customer Technical Support (CTS) provided remote technical assistance, reviewed the event with the customer, and di

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945464 ↗
• InjuryOct 30, 2025High Test Results; High Test Results

  ON (B)(6) 2025 THE CUSTOMER REPORTED OBTAINING ERRONEOUS ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULTS FOR TWENTY PATIENTS INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY ANALYZER (SERIAL NUMBER S/N (B)(6). THE CUSTOMER REPORTED THAT FOUR (4) PATIENTS HAD CHANGED TREATMENT DUE TO THE INITIAL FALSE HIGH RESULTS. NO FURTHER INFORMATION REGARDING THE CHANGE IN TREATMENT WAS PROVIDED. THIS REPORT ADDRESS THE PATIENT 4 ON 4. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM CHECK WAS PERFORMED (B)(6) 2025 AND INITIALLY FAILED FOR UNWASHED %CV AT 2.01 % (RANGE 0.00 ¿ 2.00%). WHEN REPEATED IT PASSED WITHIN SPECIFICATIONS. CALIBRATION PASSED ON (B)(6) 2025 WITH REAGENT LOT 440416 AND CALIBRATOR LOT 440251. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. THERE WAS NO EVIDENCE TO SUGGEST CARRYOVER AS THE CUSTOMER DID NOT REPORT RUNNING A SAMPLE OF HIGH TROPONIN CONCENTRATION PRIOR TO THE QUESTIONED RESULTS. THE CUSTOMER PROVIDED THE FOLLOWING ERRONEOUS ELEVATED PATIENT RESULTS FOR SIX PATIENT SAMPLES. THE INITIAL ELEVATED RESULTS (PACK LOT 440416) WERE REPEATED ON THE SAME ACCESS 2 INSTRUMENT USING A DIFFERENT RE

  Patient problems: Insufficient Information

  MAUDE report 23421925 ↗
• InjuryOct 30, 2025High Test Results; High Test Results

  ON (B)(6) 2025 THE CUSTOMER REPORTED OBTAINING ERRONEOUS ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULTS FOR TWENTY PATIENTS INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY ANALYZER (SERIAL NUMBER S/N (B)(6)). THE CUSTOMER REPORTED THAT FOUR (4) PATIENTS HAD CHANGED TREATMENT DUE TO THE INITIAL FALSE HIGH RESULTS. NO FURTHER INFORMATION REGARDING THE CHANGE IN TREATMENT WAS PROVIDED. THIS REPORT ADDRESS THE PATIENT 3 ON 4. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM CHECK WAS PERFORMED (B)(6) 2025 AND INITIALLY FAILED FOR UNWASHED %CV AT 2.01 % (RANGE 0.00 ¿ 2.00%). WHEN REPEATED IT PASSED WITHIN SPECIFICATIONS. CALIBRATION PASSED ON (B)(6) 2025 WITH REAGENT LOT 440416 AND CALIBRATOR LOT 440251. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. THERE WAS NO EVIDENCE TO SUGGEST CARRYOVER AS THE CUSTOMER DID NOT REPORT RUNNING A SAMPLE OF HIGH TROPONIN CONCENTRATION PRIOR TO THE QUESTIONED RESULTS. THE CUSTOMER PROVIDED THE FOLLOWING ERRONEOUS ELEVATED PATIENT RESULTS FOR SIX PATIENT SAMPLES. THE INITIAL ELEVATED RESULTS (PACK LOT 440416) WERE REPEATED ON THE SAME ACCESS 2 INSTRUMENT USING A DIFFERENT R

  Patient problems: Insufficient Information

  MAUDE report 23421921 ↗
• InjuryOct 30, 2025High Test Results; High Test Results

  ON (B)(6) 2025 THE CUSTOMER REPORTED OBTAINING ERRONEOUS ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULTS FOR TWENTY PATIENTS INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY ANALYZER (SERIAL NUMBER S/N (B)(6)). THE CUSTOMER REPORTED THAT FOUR (4) PATIENTS HAD CHANGED TREATMENT DUE TO THE INITIAL FALSE HIGH RESULTS. NO FURTHER INFORMATION REGARDING THE CHANGE IN TREATMENT WAS PROVIDED. THIS REPORT ADDRESS THE PATIENT 2 ON 4. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM CHECK WAS PERFORMED (B)(6) 2025 AND INITIALLY FAILED FOR UNWASHED %CV AT 2.01 % (RANGE 0.00 ¿ 2.00%). WHEN REPEATED IT PASSED WITHIN SPECIFICATIONS. CALIBRATION PASSED ON 04OCT2025 WITH REAGENT LOT 440416 AND CALIBRATOR LOT 440251. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. THERE WAS NO EVIDENCE TO SUGGEST CARRYOVER AS THE CUSTOMER DID NOT REPORT RUNNING A SAMPLE OF HIGH TROPONIN CONCENTRATION PRIOR TO THE QUESTIONED RESULTS. THE CUSTOMER PROVIDED THE FOLLOWING ERRONEOUS ELEVATED PATIENT RESULTS FOR SIX PATIENT SAMPLES. THE INITIAL ELEVATED RESULTS (PACK LOT 440416) WERE REPEATED ON THE SAME ACCESS 2 INSTRUMENT USING A DIFFERENT REA

  Patient problems: Insufficient Information

  MAUDE report 23421918 ↗
• InjuryOct 30, 2025High Test Results; High Test Results

  ON (B)(6) 2025 THE CUSTOMER REPORTED OBTAINING ERRONEOUS ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULTS FOR TWENTY PATIENTS INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY ANALYZER (SERIAL NUMBER S/N (B)(6)). THE CUSTOMER REPORTED THAT FOUR (4) PATIENTS HAD CHANGED TREATMENT DUE TO THE INITIAL FALSE HIGH RESULTS. NO FURTHER INFORMATION REGARDING THE CHANGE IN TREATMENT WAS PROVIDED. THIS REPORT ADDRESS THE PATIENT 1 ON 4. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM CHECK WAS PERFORMED (B)(6) 2025 AND INITIALLY FAILED FOR UNWASHED %CV AT 2.01 % (RANGE 0.00 ¿ 2.00%). WHEN REPEATED IT PASSED WITHIN SPECIFICATIONS. CALIBRATION PASSED ON (B)(6) 2025 WITH REAGENT LOT 440416 AND CALIBRATOR LOT 440251. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. THERE WAS NO EVIDENCE TO SUGGEST CARRYOVER AS THE CUSTOMER DID NOT REPORT RUNNING A SAMPLE OF HIGH TROPONIN CONCENTRATION PRIOR TO THE QUESTIONED RESULTS. THE CUSTOMER PROVIDED THE FOLLOWING ERRONEOUS ELEVATED PATIENT RESULTS FOR SIX PATIENT SAMPLES. THE INITIAL ELEVATED RESULTS (PACK LOT 440416) WERE REPEATED ON THE SAME ACCESS 2 INSTRUMENT USING A DIFFERENT R

  Patient problems: Insufficient Information

  MAUDE report 23421909 ↗
• DeathJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2002 BECKMAN COULTER WAS MADE AWARE OF A PATIENT DEATH POTENTIALLY ASSOCIATED WITH THE ACCUTNI+3 ASSAY (ACCESS ACCUTNI+3, PART NUMBER A98143 AND LOT NUMBER 125173) THROUGH NOTIFICATION FROM THE FDA. ONE PATIENT SAMPLE WAS TESTED WITH THE ACCESS ACCUTNI+3 ASSAY; THE SAMPLE GENERATED A RESULT WHICH WAS WITHIN THE ASSAY'S NORMAL REFERENCE RANGE. THE RESULT WAS NOT QUESTIONED BY PHYSICIAN. PATIENT SAMPLE WAS NOT RE-TESTED AND NO SEQUENTIAL SAMPLES FROM THIS PATIENT WERE TESTED USING THE ACCESS ACCUTNI+3 ASSAY FOLLOWING GENERATION OF THE FIRST ACCUTNI+3 RESULT. THE PATIENT SAMPLE WAS NOT TESTED ON ANY OTHER METHODOLOGIES AND NO SERIAL DRAWS WERE PERFORMED BY THE CUSTOMER. THERE WAS A REPORT OF A DEATH. THE PATIENT PRESENTED WITH REPORTED CHEST PAIN AND WAS TREATED IN THE EMERGENCY ROOM ON (B)(6) 2021, AND WAS SUBSEQUENTLY DISCHARGED. THE PATIENT PASSED AWAY FIVE DAYS LATER, NOT AT THE HOSPITAL. THE CAUSE OF DEATH IS UNKNOWN. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. PER THE HOSPITAL'S VERBAL CONFIRMATION, SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUA

  Patient problems: Insufficient Information

  MAUDE report 14958054 ↗
• InjuryMay 13, 2022High Test Results; High Test Results

  ON 04MAY2022 THE CUSTOMER REPORTED THAT ON (B)(6) 2022, AN ERRONEOUS NON-REPRODUCIBLE ELEVATED TROPONIN I (ACCESS ACCUTNI+3, PART NUMBER A98264 AND LOT NUMBER 125664) WAS GENERATED FOR ONE PATIENT ON THE CUSTOMER'S DXI (DXI 600 ACCESS IMMUNOASSAY ANALYZER W/SPOT B, PART NUMBER A71460 AND SERIAL NUMBER (SN) (B)(4). THE RESULT OF 0.07 NG/ML WAS REPORTED OUT OF THE LABORATORY. THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN CONNECTION WITH THE EVENT. THE CUSTOMER REPORTED THAT THE PATIENT WAS SENT FOR AN ANGIOGRAM. NO FURTHER INFORMATION REGARDING PATIENT TREATMENT OR OUTCOME WAS PROVIDED. PATIENT WAS REDRAWN AND SAMPLE WAS RUN ON CUSTOMER'S OTHER DXI (DXI 600 ACCESS IMMUNOASSAY ANALYZER W/SPOT B, PART NUMBER A71460 AND SN (B)(4) AND RESULT OF 0.00 NG/ML WAS OBTAINED. THE ORIGINAL SAMPLE WAS THEN RETESTED ON DXI SN (B)(4) AND A RESULT OF 0.01 NG/ML WAS OBTAINED. THE ORIGINAL SAMPLE WAS THEN TESTED ON DXI SN (B)(4) AND A RESULT OF 0.03 NG/ML WAS OBTAINED. THE SECOND SAMPLE WAS ALSO TESTED IN DUPLICATE ON DXI SN (B)(4) AND RESULTS OF 0.01 NG/ML AND 0.00 G/ML WERE OBTAINED. SYSTEM PERFORMANCE INDICATORS SUCH AS CALIBRATION AND QUALITY CONTROL (QC) WERE PASSING WITHIN S

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

  MAUDE report 14402629 ↗
• InjuryMar 3, 2022High Test Results; High Test Results

  ON (B)(6) 2022 THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI+3, PART NUMBER A98264 AND LOT NUMBER 125064) RESULTS ON THE CUSTOMER'S DXI (DXI 600 ACCESS IMMUNOASSAY ANALYZER, PART NUMBER A30260 AND SERIAL NUMBER (B)(4)) FOR ONE PATIENT SAMPLE. THE INITIAL RESULT OF 15.55 NG/ML WAS NOT RELEASED FROM THE LABORATORY. THE CUSTOMER RERAN THE PATIENT SAMPLE ON THEIR ALTERNATE DXI (SERIAL NUMBER (B)(4)) AND OBTAINED A RESULT OF 0.75 NG/ML. RETESTING OF THE PATIENT SAMPLE ON THE ORIGINAL DXI (SERIAL NUMBER (B)(4)) GENERATED A TROPONIN I RESULT OF 0.76 NG/ML AND 0.75 NG/ML. THE CUSTOMER REPORTED A DELAY TO PATIENT CARE WHICH OCCURRED IN CONNECTION WITH THIS EVENT. DETAILS OF THE DELAY TO PATIENT CARE WERE REQUESTED BY BECKMAN COULTER BUT WERE NOT PROVIDED. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. QUALITY CONTROL WAS PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. THE CUSTOMER REPORTED THEY RAN A TEST PATIENT SAMPLE (NO TROPONIN TESTS HAD BEEN ORDERED BY THE PHYSICIAN) FOR TROUBLESHOOTING PURPOSES. THE TEST SAMPLE RECOVERED AT 13.42 NG/ML INITIALLY ON T

  Patient problems: Insufficient Information

  MAUDE report 13660527 ↗
• InjuryFeb 28, 2022High Test Results; High Test Results

  ON (B)(6) 2022 THE CUSTOMER REPORTED OBTAINING ONE NON-REPRODUCIBLE FALSELY ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULT FOR ONE PATIENT INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (SERIAL NUMBER (B)(4)). ON (B)(6) 2022 THE INITIAL TNIDX PATIENT RESULT WAS 838.8 PG/ML. THE SAMPLE WAS REPEATED TWICE WITH THE FOLLOWING LOWER RESULTS: 4.0 PG/ML AND 3.7 PG/ML. ALL THREE SAMPLE REPLICATES WERE RUN ON THE REAGENT PACK LOT 124617, PACK SERIAL NUMBER (B)(4). THE CUSTOMER REPORTED THE PATIENT RECEIVED CARDIAC CATHETER ABLATION TREATMENT DUE TO THE FALSELY ELEVATED TNIDX RESULT. BECKMAN COULTER LOCAL SUPPORT ASSISTED THE CUSTOMER WITH VERIFYING THE SYSTEM PERFORMANCE. FROM (B)(6) TO (B)(6) 2022, THE CUSTOMER RAN TEST SAMPLES IN DUPLICATE AS PART OF TROUBLESHOOTING. THE CUSTOMER PROVIDED SIX (6) TEST SAMPLES RESULTS USING REAGENT PACK SERIAL NUMBER 499 AND 7562, WHICH WERE ALSO NON-REPRODUCIBLE: TEST SAMPLE ONE: INITIAL RESULT 155.3 PG/ML REPEATED AT 6.6 PG/ML. TEST SAMPLE TWO: INITIAL RESULT 2262.2 PG/ML REPEATED AT 5.2 PG/ML. TEST SAMPLE THREE: INITIAL RESULT 1764.4 PG/ML REPEATED AT 2.5 PG/ML. TEST SAMPLE FOUR: INITIAL RESULT 972.6 PG/ML REPEATED AT 37.78 PG/ML.

  Patient problems: Insufficient Information

  MAUDE report 13618566 ↗
• InjuryFeb 15, 2022High Test Results; High Test Results

  ON (B)(6) 2022 THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI+3, PART NUMBER A98143 AND LOT NUMBER 124772) RESULTS ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER A25640 AND SERIAL NUMBER (B)(4)) FOR ONE PATIENT SAMPLE. THE INITIAL RESULT OF 0.55 NG/ML WAS RELEASED FROM THE LABORATORY. RETESTING OF THE PATIENT SAMPLE GENERATED A TROPONIN I RESULT OF 0.02 NG/ML; A CORRECTED REPORT WAS ISSUED. THE CUSTOMER REPORTED A CHANGE TO PATIENT TREATMENT WHICH OCCURRED IN CONNECTION WITH THIS EVENT. DETAILS OF THE CHANGE TO PATIENT TREATMENT WERE REQUESTED BY BECKMAN COULTER BUT WERE NOT PROVIDED. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. SAMPLE TYPE, COLLECTION, PROCESSING AND HANDLING INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 13535615 ↗
• InjuryJan 10, 2022High Test Results; High Test Results

  ON 27DEC2021 THE CUSTOMER REPORTED OBTAINING REPRODUCIBLE ELEVATED TROPONIN I (ACCESS ACCUTNI+3, PART NUMBER A98143 AND LOT NUMBER 125173) RESULTS FOR ONE PATIENT INVOLVING THE LABORATORY'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 81600N AND SERIAL NUMBER (B)(4)) ON (B)(6) 2021. THE INITIAL ELEVATED RESULT OF 0.7 NG/ML WAS RELEASED FROM THE LABORATORY. THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN ASSOCIATION WITH THIS EVENT. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AND ADMINISTERED TREATMENT. DETAILS REGARDING TREATMENT WERE REQUESTED BUT WERE NOT PROVIDED BY THE CUSTOMER. A SAMPLE FROM THE PATIENT WAS COLLECTED AND TESTED FOR TROPONIN USING THE SIEMENS VISTA ASSAY AT THE OTHER HOSPITAL; RESULT WAS <0.2 NG/ML ALL SAMPLES WERE REPEAT TESTED ON THE ACCESS 2 PLATFORM AND RESULTS WERE CONSISTENT AT 0.7 NG/ML SAMPLES ORIGINALLY TESTED ON THE ACCESS 2 PLATFORM WERE TESTED ON THE SIEMENS VISTA PLATFORM AND LOWER RESULTS WERE OBTAINED. NO ERROR MESSAGES OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONNECTION WITH THE EVENT. THERE WERE NO REPORTS OF HARDWARE INTERVENTIONS PERFORMED OR HARDWARE PARTS REPLACED. NO OTHER PATIENT RESULTS WERE CALLED INTO

  Patient problems: Insufficient Information

  MAUDE report 13206081 ↗
• InjuryOct 25, 2021High Test Results; High Test Results

  ON (B)(6) 2021 THE CUSTOMER REPORTED OBTAINING ONE NON-REPRODUCIBLE FALSE HIGH TROPONIN I (ACCESS ACCUTNI+3) RESULT INVOLVING THE LABORATORY'S ACCESS 2 SECTION, DXC 600I PACKAGED ANALYZER (SERIAL NUMBER (B)(4)). ON (B)(6) 2021, A FALSELY ELEVATED TNIA2 RESULT OF 1.64 NG/ML WAS GENERATED FOR ONE PATIENT SAMPLE. THE ELEVATED TNIA2 RESULT WAS QUESTIONED AS A SUBSEQUENT SAMPLE DRAW RECOVERED AT 0.01 NG/ML AND 0.01 NG/ML. THE SAMPLE THAT PRODUCED THE 1.64 NG/ML RESULT WAS REPEATED AND RESULTS OF 0.01 NG/ML AND 0.01 NG/ML WERE ALSO OBTAINED. THE PATIENT WAS ADMITTED BASED ON THE FALSELY ELEVATED TNIA2 RESULT AND TREATMENT WAS STARTED. PATIENT TREATMENT PROVIDED WAS NOT SPECIFIED IN THIS EVENT. NO FURTHER INFORMATION HAS BEEN PROVIDED. CALIBRATION PASSED ON (B)(6) 2021 USING REAGENT LOT 124772 AND CALIBRATOR LOT 922645. QUALITY CONTROL WAS WITHIN ACCEPTABLE RANGE. PASSING SYSTEM CHECKS WERE OBTAINED ON (B)(6) 2021 AND (B)(6) 2021. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. ON (B)(6) 2021, THE CUSTOMER RAN A 15 REPLICATE TNIA2 PRECISION STUDY WHICH RECOVERED AT 2.75 NG/ML MEAN, 0.05 SD (ST

  Patient problems: Insufficient Information

  MAUDE report 12688761 ↗
• InjuryOct 6, 2021High Test Results; High Test Results

  THE CUSTOMER INITIALLY REPORTED SURGERY WAS DELAYED DUE TO THE FALSELY ELEVATED TNIA2 RESULT. ON (B)(6) 2021, A WRITTEN ATTEMPT WAS MADE TO OBTAINED ADDITIONAL INFORMATION REGARDING THE SURGERY THAT WAS DELAYED. ON (B)(6) 2021, THE CUSTOMER FURTHER CLARIFIED THE PATIENT WAS SCHEDULED FOR A TREADMILL STRESS TEST, AND NOT A SURGERY, ON (B)(6) 2021 WHICH WAS CANCELED DUE TO THE ELEVATED TNIA2 RESULT OF 2.43 NG/ML. THE CUSTOMER DID REPORT THE PATIENT WAS TAKEN TO THE CATHETER LABORATORY FOR AN ANGIOGRAM WHEN THE TNIA2 RESULT OF 2.43 NG/ML WAS GENERATED; HOWEVER, THE ANGIOGRAM WAS CANCELED WHEN THE LOW TROPONIN RESULT OF <0.02 NG/ML WAS OBTAINED. THE CUSTOMER REPORTED NO MEDICATION WAS GIVEN TO THE PATIENT IN THE CATHETER LABORATORY.

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

  MAUDE report 12583649 ↗
• InjurySep 13, 2021High Test Results; High Test Results

  ON (B)(6) 2021 THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE FALSE HIGH TROPONIN I (ACCESS ACCUTNI+3) RESULTS FOR TWO SAMPLES FROM ONE PATIENT INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNO ANALYZER ((B)(4)). THE ELEVATED RESULTS (BOTH AT 0.18 NG/ML ON (B)(6) 2021) WERE QUESTIONED BY THE ORDERING PHYSICIAN AS A THIRD DRAW FROM THE PATIENT WAS NEGATIVE (0.00 NG/ML) FOR MYOCARDIAL INFARCTION. THE CUSTOMER REPEATED THE TNIDX RESULTS ON SAME ANALYZER AND LOWER RESULTS WERE OBTAINED (ALL RESULTS WERE AT 0.00 NG/ML). THE PATIENT WAS ADMINISTERED ASPIRIN AND GIVEN A CT (COMPUTERIZED TOMOGRAPHY) SCAN. THE ORDERING PHYSICIAN HAD ORDERED A CT SCAN OF THE HEAD, NECK, AND CHEST. THE PATIENT STARTED THE CT SCAN OF THE HEAD AND NECK BUT WAS UNABLE TO COMPLETE THE CHEST CT. MULTIPLE WRITTEN ATTEMPT WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING IF CONTRAST MEDIA WAS ADMINISTERED TO THE PATIENT FOR THE CT SCAN. NO FURTHER INFORMATION WAS PROVIDED. CALIBRATION PASSED ON (B)(6) 2021 USING REAGENT LOT 124536 AND CALIBRATOR LOT 922646. QUALITY CONTROL WAS WITHIN ACCEPTABLE RANGE. A PASSING SYSTEM CHECK WAS OBTAINED ON (B)(6) 2021. ON (B)(6) 2021, THE CUSTOMER RAN A SYSTEM CHECK WHICH

  Patient problems: Insufficient Information

  MAUDE report 12459653 ↗
• InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021 THE CUSTOMER REPORTED ERRONEOUS NON-REPRODUCIBLE ELEVATED TROPONIN I (ACCESS ACCUTNI+3 FOR USE ON DXI, PART NUMBER A98264 AND LOT NUMBER 922912) WERE GENERATED ON THE CUSTOMER'S DXI 800 (DXI 800 ACCESS IMMUNOASSAY W/DUAL GANTRY, PART NUMBER A71457 AND SERIAL NUMBER (B)(4)) FOR ONE (1) PATIENT. THE INITIAL RESULT WAS 4.51 NG/ML (00:13); THE SAMPLE WAS REPEAT TESTED AND A RESULT OF 0.00 NG/ML (07:36) WAS OBTAINED. THE CUSTOMER DID NOT PROVIDE A REFERENCE RANGE; THE BECKMAN COULTER REFERENCE RANGE FOR TROPONIN I IS <0.04 NG/ML. THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN CONNECTION WITH THIS EVENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND ADMINISTERED LOVENOX (DOSAGE NOT PROVIDED). THE PATIENT WAS DISCHARGED THE SAME DAY AFTER THE RESULT OF 0.00 NG/ML WAS OBTAINED AT 07:36. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PERFORMING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. A PRECISION RUN PERFORMED BY THE CUSTOMER ON (B)(6) 2021 PASSED WITHIN ASSAY SPECIF

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

  MAUDE report 12150394 ↗

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