Access AccuTnI+3 A98143Recalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 15099590209322), received between Sep 27, 2016 and Oct 30, 2025 — classified as 1 death, 75 injuries, 30 malfunctions.

The most frequently reported specific device problem is “High Test Results” (82 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 106 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 11, 2020High Test Results; High Test Results

  ON (B)(6) 2020, THE CUSTOMER REPORTED OBTAINING REPRODUCIBLE FALSE ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULTS FOR ONE PATIENT INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY ANALYZER (SERIAL NUMBER (B)(4)). ONE PATIENT WENT TO HOSPITAL FOR CHEST PAIN ON (B)(6) 2020, THE ACCUTNI+3 RESULT WAS HIGH AT 5.57 NG/ML. THE ELECTROCARDIOGRAM ECG SHOWED SINUS BRADYCARDIA, INCOMPLETE RIGHT BUNDLE BRANCH TO BLOCK PATTERN AND EARLY REPOLARIZATION CHANGES. ON (B)(6) 2020, THE ACCUTNI+3 RESULT WAS SIMILAR HIGH AT 5.36 NG/ML. FIVE OTHER ACCESS ACCUTNI+3 RETESTS (THREE ON THE SAME INSTRUMENT, TWO ON A DXI ANALYZER) HAVE BEEN PERFORMED DURING THE HOSPITALIZATION AND ALL WERE ELEVATED ABOVE THE REFERENCE RANGE OF 0.04 NG/ML AND DISCORDANT WITH THE PATIENT CLINICAL FILE. THE ACCESS ACCUTNI+3 RESULTS WERE ALSO DISCORDANT WITH THE POINT-OF-CARE TESTING (POCT) (NO FURTHER INFORMATION PROVIDED) PERFORMED ON (B)(6) 2020, (<0.02 NG/ML) AND WITH THE ABBOTT CTNI RESULT PERFORMED ON (B)(6) 2020, (0.001 NG/ML). THE RESULTS OF OTHER MYOCARDIAL ENZYMES (INCLUDING MYOGLOBIN, CK-MB, CK, BNP AND LDH) WERE ALL NEGATIVE (DATA NOT PROVIDED) AND DISCORDANT WITH THE ACCESS ACCUTNI+3 RESULTS. THE CUSTOMER REPORTED THAT

  Patient problems: Misdiagnosis

  MAUDE report 10521320 ↗
• InjuryAug 6, 2020High Test Results; High Test Results

  ON 26JUL2020 THE CUSTOMER REPORTED THAT ON (B)(6) 2020, A REPRODUCIBLE ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULT OF 1.048 NG/ML WAS GENERATED ON THE CUSTOMER'S ACCESS2 IMMUNOASSAY SYSTEM (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)). THE PATIENT WAS RETESTED ON (B)(6) 2020 AND A TROPONIN I RESULT OF 1.193 NG/ML WAS OBTAINED. THERE WAS A REPORT OF CHANGE TO PATIENT MANAGEMENT IN ASSOCIATION WITH THIS EVENT. ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL. A DIAGNOSIS OF MYOCARDIAL DAMAGE WAS MADE AND THE PATIENT WAS TREATED WITH PRESCRIPTION SODIUM CREATINE PHOSPHATE AND RUI ANJI (DOSES AND DOSAGE INTERVALS NOT PROVIDED). DURING THE TIME INTERVAL OF (B)(6) 2020 THE PATIENT WAS TREATED WITH THE TWO PRESCRIPTION MEDICATIONS. ON (B)(6) 2020 THE PATIENT WAS DRAWN AND THE SAMPLE WAS TESTED USING THE ACCESS HIGH SENSITIVITY TROPONIN I ASSAY (PART NUMBER B25699; LOT NOT PROVIDED) AND A RESULT OF 0.8 PG/ML WAS OBTAINED. THE PHYSICIANS THEN QUESTIONED THE TROPONIN I RESULTS GENERATED USING THE ACCESS ACCUTNI+3 ASSAY. THERE WAS NO REPORT OF HARDWARE ERRORS OR ASSAY ISSUES AT THE TIME OF THE EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK AND QUALITY CONTROL WERE PERFORM

  Patient problems: No Code Available

  MAUDE report 10375935 ↗
• InjuryJun 30, 2020High Test Results; High Test Results

  ON (B)(6) 2020 THE CUSTOMER REPORTED THAT REPRODUCIBLE ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULTS HAD BEEN OBTAINED ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY SYSTEM (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)) FOR ONE PATIENT. THE SAMPLE PRODUCED A RESULT OF 79.30 NG/ML; REPEAT TESTING OF THE SAME SAMPLE PRODUCED A RESULT OF 77.40 NG/ML. THE PATIENT WAS REDRAWN AND THE NEW SAMPLE PRODUCED A RESULT OF 79.79 NG/ML. THE INITIAL RESULTS OF 79.30 NG/ML AND 79.79 NG/ML WERE RELEASED FROM THE LABORATORY. THE CUSTOMER NOTED THAT A TROPONIN TEST PERFORMED AT ANOTHER FACILITY (NOT PROVIDED) ON A ROCHE PLATFORM (PLATFORM DETAILS NOT PROVIDED) PRODUCED A 'NEGATIVE' RESULT. THE CUSTOMER DID NOT PROVIDE REFERENCE RANGES. THE BECKMAN COULTER REFERENCE RANGE FOR THE ACCUTNI+3 ASSAY IS 0.02 (0.01 - 0.05 NG/ML). THERE WAS A REPORT OF CHANGE TO PATIENT CARE OR TREATMENT WHICH OCCURRED IN CONNECTION WITH THIS EVENT. THE PATIENT WAS TREATED FOR A MYOCARDIAL INFARCTION. ATTEMPTS WERE MADE TO OBTAIN INFORMATION REGARDING SPECIFIC TREATMENT(S) PROVIDED BUT THE CUSTOMER WAS UNABLE TO PROVIDE SPECIFIC DETAILS REGARDING THE TREATMENT(S) PROVIDED. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRAT

  Patient problems: No Code Available

  MAUDE report 10212851 ↗
• MalfunctionJun 22, 2020Incorrect Measurement; Incorrect Measurement

  ON 04JUN2020 THE CUSTOMER REPORTED ERRONEOUS ERRATIC NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI +3) RESULTS WERE GENERATED ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)) OVER A DATE RANGE STARTING ON (B)(6) 2020 AND ENDING ON (B)(6) 2020. THE CUSTOMER REPORTED THAT ORIGINAL RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER INDICATED THERE WAS NO CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN CONJUNCTION WITH THIS EVENT. IT IS UNKNOWN WHETHER THE QUESTIONED RESULTS WERE ERRONEOUSLY HIGH OR LOW; TWO WRITTEN ATTEMPTS HAVE BEEN MADE TO OBTAIN THIS INFORMATION BUT TO DATE NO RESPONSE HAS BEEN PROVIDED BY THE CUSTOMER. MEDWATCH NUMBER 2122870-2020-00044 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00045 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00046 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00047 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00049 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00050 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 202

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10181508 ↗
• MalfunctionJun 22, 2020Incorrect Measurement; Incorrect Measurement

  FNC (B)(4). EVENT OCCURED IN (B)(6) ON (B)(6) 2020. DESCRIPTION OF THE INCIDENT / INCIDENT REPORT: "THE MEDICAL DEVICE FIXIT WAS BROKEN DURING SURGERY".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10181495 ↗
• MalfunctionJun 22, 2020Incorrect Measurement; Incorrect Measurement

  ON (B)(6) 2020 THE CUSTOMER REPORTED ERRONEOUS ERRATIC NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI +3) RESULTS WERE GENERATED ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)) OVER A DATE RANGE STARTING ON (B)(6) 2020 AND ENDING ON (B)(6) 2020. THE CUSTOMER REPORTED THAT ORIGINAL RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER INDICATED THERE WAS NO CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN CONJUNCTION WITH THIS EVENT. IT IS UNKNOWN WHETHER THE QUESTIONED RESULTS WERE ERRONEOUSLY HIGH OR LOW; TWO WRITTEN ATTEMPTS HAVE BEEN MADE TO OBTAIN THIS INFORMATION BUT TO DATE NO RESPONSE HAS BEEN PROVIDED BY THE CUSTOMER. MEDWATCH NUMBER 2122870-2020-00044 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00045 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00046 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00047 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00048 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00049 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10181440 ↗
• MalfunctionJun 22, 2020Incorrect Measurement; Incorrect Measurement

  ON 04JUN2020 THE CUSTOMER REPORTED ERRONEOUS ERRATIC NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI +3) RESULTS WERE GENERATED ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)) OVER A DATE RANGE STARTING ON (B)(6) 2020 AND ENDING ON (B)(6) 2020. THE CUSTOMER REPORTED THAT ORIGINAL RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER INDICATED THERE WAS NO CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN CONJUNCTION WITH THIS EVENT. IT IS UNKNOWN WHETHER THE QUESTIONED RESULTS WERE ERRONEOUSLY HIGH OR LOW; TWO WRITTEN ATTEMPTS HAVE BEEN MADE TO OBTAIN THIS INFORMATION BUT TO DATE NO RESPONSE HAS BEEN PROVIDED BY THE CUSTOMER. MEDWATCH NUMBER 2122870-2020-00044 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00046 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00047 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00048 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00049 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10181437 ↗
• MalfunctionJun 22, 2020Incorrect Measurement; Incorrect Measurement

  ON 04JUN2020 THE CUSTOMER REPORTED ERRONEOUS ERRATIC NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI +3) RESULTS WERE GENERATED ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)) OVER A DATE RANGE STARTING ON (B)(6) 2020 AND ENDING ON (B)(6) 2020. THE CUSTOMER REPORTED THAT ORIGINAL RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER INDICATED THERE WAS NO CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN CONJUNCTION WITH THIS EVENT. IT IS UNKNOWN WHETHER THE QUESTIONED RESULTS WERE ERRONEOUSLY HIGH OR LOW; TWO WRITTEN ATTEMPTS HAVE BEEN MADE TO OBTAIN THIS INFORMATION BUT TO DATE NO RESPONSE HAS BEEN PROVIDED BY THE CUSTOMER. MEDWATCH NUMBER 2122870-2020-00044 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00045 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00047 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00048 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00049 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10181426 ↗
• MalfunctionJun 22, 2020Incorrect Measurement; Incorrect Measurement

  ON 04JUN2020 THE CUSTOMER REPORTED ERRONEOUS ERRATIC NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI +3) RESULTS WERE GENERATED ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)) OVER A DATE RANGE STARTING ON (B)(6) 2020 AND ENDING ON (B)(6) 2020. THE CUSTOMER REPORTED THAT ORIGINAL RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER INDICATED THERE WAS NO CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN CONJUNCTION WITH THIS EVENT. IT IS UNKNOWN WHETHER THE QUESTIONED RESULTS WERE ERRONEOUSLY HIGH OR LOW; TWO WRITTEN ATTEMPTS HAVE BEEN MADE TO OBTAIN THIS INFORMATION BUT TO DATE NO RESPONSE HAS BEEN PROVIDED BY THE CUSTOMER. MEDWATCH WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00045 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00046 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00047 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00048 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00049 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10181384 ↗
• MalfunctionJun 22, 2020Incorrect Measurement; Incorrect Measurement

  ON 04JUN2020 THE CUSTOMER REPORTED ERRONEOUS ERRATIC NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI +3) RESULTS WERE GENERATED ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)) OVER A DATE RANGE STARTING ON (B)(6) 2020 AND ENDING ON (B)(6) 2020. THE CUSTOMER REPORTED THAT ORIGINAL RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER INDICATED THERE WAS NO CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN CONJUNCTION WITH THIS EVENT. IT IS UNKNOWN WHETHER THE QUESTIONED RESULTS WERE ERRONEOUSLY HIGH OR LOW; TWO WRITTEN ATTEMPTS HAVE BEEN MADE TO OBTAIN THIS INFORMATION BUT TO DATE NO RESPONSE HAS BEEN PROVIDED BY THE CUSTOMER. MEDWATCH NUMBER 2122870-2020-00044 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00045 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00046 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00048 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER 2122870-2020-00049 WILL ADDRESS THE SAMPLE(S) COLLECTED ON (B)(6) 2020. MEDWATCH NUMBER

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10181250 ↗
• InjuryMay 21, 2020High Test Results; High Test Results

  ON (B)(6) 2020 THE CUSTOMER REPORTED AN ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULT OF 1.62 NG/ML HAD BEEN GENERATED ON THE CUSTOMER'S ACCESS2 IMMUNOASSAY INSTRUMENT, PART NUMBER 81600N AND SERIAL NUMBER (B)(4) FOR ONE PATIENT. THIS RESULT WAS BEYOND THE CUSTOMER'S REFERENCE RANGE OF <0.04 NG/ML AND DISCORDANT TO THE PATIENT'S CLINICAL EXPECTATION. THE CUSTOMER THEN TESTED THE PATIENT'S SAMPLE ON A COMPETITOR DEVICE AND OBTAINED A RESULT OF 0.006 NG/ML. REFERENCE RANGE FOR COMPETITOR DEVICE WAS NOT PROVIDED. THERE WAS A REPORT OF CHANGE TO PATIENT CARE OR TREATMENT WHICH OCCURRED IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPORTED THAT DUE TO THE DISCORDANT RESULTS BETWEEN THE TWO PLATFORMS, THE PATIENT UNDERWENT A CORONARY ANGIOGRAPHY, THE RESULT OF WHICH DID NOT SHOW ANY BLOCKAGES. NO ADDITIONAL REPORT OF CHANGES TO PATIENT TREATMENT OR OUTCOME WERE REPORTED. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF SAMPLE INTEGRITY ISSUES. SAMPLE AND SAMPLE PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE STORAGE AND HANDLING CONDITIONS WERE NOT PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10080114 ↗
• InjuryMay 4, 2020High Test Results; High Test Results

  ON (B)(6) 2020 THE CUSTOMER REPORTED THAT A NON-REPRODUCIBLE ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULT HAD BEEN GENERATED ON THE CUSTOMER'S ACCESS 2 SECTION, DXC 600I PACKAGED (SERIAL NUMBER (B)(4)) FOR ONE PATIENT SAMPLE. THE INITIAL ELEVATED ACCESS ACCUTNI+3 RESULT OF 6.12 NG/ML WAS RELEASED FROM THE LABORATORY. THE RESULT WAS QUESTIONED BY NURSE OR PHYSICIAN. THE DAY AFTER, THE CUSTOMER REPORTED RETESTING TWICE THE SAMPLE ON THE SAME ANAYZER; BOTH REPEATED RESULTS WERE 0.00 NG/ML. THE CUSTOMER NORMAL REFERENCE RANGE IS < 0.04 NG/ML. THERE WAS A REPORT OF CHANGE TO PATIENT CARE OR TREATMENT WHICH OCCURRED IN CONNECTION WITH THIS EVENT. THE PATIENT WAS ADMINISTERED HEPARIN. NO REPORT OF ADDITIONAL CHANGES TO PATIENT MANAGEMENT WAS REPORTED. CALIBRATION AND QUALITY CONTROL WERE PERFORMING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. SYSTEM CHECKS WERE PERFORMED ON 03APR2020, 10APR2020 AND 17APR2020 AND PASSED WITHIN SPECIFICATIONS. THE SAMPLE WAS A SERUM SAMPLE, COLLECTED AND TESTED IN A SERUM SEPARATOR TUBE WITH GEL AND CENTRIFUGED FOR 10 MINUTES AT 3750 RPM (1960 G) AT ROOM TEMPERATURE. A SMALL CLOT WAS OBSERVED FLOATING ON TOP OF THE SERUM AND REMOVED BEFORE THE SAMPLE WA

  Patient problems: No Code Available

  MAUDE report 10020179 ↗
• InjuryMar 18, 2020High Test Results; High Test Results

  ON (B)(6) 2020 THE CUSTOMER REPORTED OBTAINING ONE NON REPRODUCIBLE FALSE ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULT FOR ONE PATIENT INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY ANALYZER (SERIAL NUMBER (B)(4)). THE INITIAL RESULT 0.728 NG/ML WAS QUESTIONED DUE TO THE ERRATIC NATURE OF THE RESULT AND WAS REPEATED ON THE SAME ANALYZER WITH A DISCORDANT RESULT (0.010 NG/ML). A SECOND SAMPLE WAS TESTED WITH SIMILAR LOW RESULTS AT 0.014 NG/ML AND 0.010 NG/ML. THE CUSTOMER REPORTED THE PATIENT WAS GIVEN HEPARIN AS TREATMENT. THE CUSTOMER STATED THERE WAS NO DEATH OR INJURY TO PATIENT DUE TO ASSOCIATED RESULTS. ANY ADDITIONAL IMPACT OR CHANGE TO PATIENT TREATMENT HAS NOT BEEN SPECIFIED IN THIS EVENT. THE CUSTOMER STATED NO INSTRUMENT ERRORS POSTED PRIOR TO PATIENT RUN AND QC WAS PASSING PRIOR TO PATIENT RUN. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON 04MAR2020. THE FSE PERFORMED HARDWARE CHECKS AND REPLACED THE PERI-PUMP TUBING. THE FSE PERFORMED PIPETTOR TIP ALIGNMENTS AND ADJUSTMENTS, AND PERFORMED MIXER SPEED ADJUSTMENT. THE FSE PRIMED THE SYSTEM TO CHECK FOR AIR AND LEAKS. AFTER REPAIR, THE FSE PERFORMED SYSTEM CHECK AND A TEN POINT PRE

  Patient problems: No Code Available

  MAUDE report 9849266 ↗
• MalfunctionFeb 12, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020 THE CUSTOMER REPORTED OBTAINING ERRATIC TROPONIN I (ACCESS ACCUTNI+3) RESULTS FOR ONE PATIENT INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY ANALYZER (SERIAL NUMBER (B)(4)). THE FOLLOWING RESULTS (B)(6) WERE QUESTIONED DUE TO THE ERRATIC NATURE OF THE RESULTS. THE EXPECTED OR CORRECT RESULTS WERE NOT SPECIFIED IN THIS EVENT. A SECOND SAMPLE WAS TESTED WITH SIMILAR RESULTS AT (B)(6). THE CUSTOMER REFERENCE RANGE IS 0.00 - 0.02 NG/ML. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPORTED THE PATIENT WAS SENT TO THE HOSPITAL FOR FURTHER EVALUATION DUE TO THE REPEATABLE HIGH RESULTS AND NOT DUE TO THE ERRONEOUSLY LOW RESULT THAT WAS STILL CONSIDERED POSITIVE. ANY TREATMENT GIVEN BASED ON THE ERRONEOUS RESULT GENERATED WOULD HAVE BEEN SIMILAR. ANY ADDITIONAL IMPACT OR CHANGE TO PATIENT TREATMENT HAS NOT BEEN SPECIFIED IN THIS EVENT. THE CUSTOMER HAS NOT PROVIDED FURTHER INFORMATION ON ANY CHANGE OR IMPACT TO PATIENT TREATMENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON 23JAN2020. AVAILABLE SYSTEM PERFORMANCE INDICATORS OF SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL DID NOT DE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9699017 ↗
• InjuryNov 11, 2019High Test Results; High Test Results

  ON (B)(6) 2019, THE CUSTOMER REPORTED THAT ON (B)(6) 2019 AN ERRONEOUS ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULT WAS GENERATED FOR ONE PATIENT INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY SYSTEM PORTION OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM SERIAL NUMBER (B)(4). THE INITIAL RESULT OBTAINED WAS 3.47 NG/ML. THE SAMPLE WAS REPEAT TESTED ON THE LABORATORY'S ACCESS 2 IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4) AND A RESULT OF 0.07 NG/ML WAS OBTAINED. THE SAMPLE WAS REPEATED AGAIN ON THE LABORATORY'S ACCESS 2 IMMUNOASSAY SYSTEM PORTION OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM SERIAL NUMBER (B)(4) AND A RESULT OF 0.06 NG/DL WAS OBTAINED. THE INITIAL RESULT WAS REPORTED OUT OF THE LABORATORY. THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT. THE PATIENT WAS TREATED WITH A HEPARIN BOLUS (DOSE NOT PROVIDED). THE CUSTOMER ALSO INDICATED THAT TRANSFER TO AN ALTERNATE HOSPITAL WAS INITIATED FOR THE PATIENT. UPON REPEAT TESTING, CORRECTED REPORT WAS ISSUED AND PATIENT TRANSFER WAS CANCELLED. THE LAB USES A NORMAL RANGE OF <0.05NG/ML. THE LAB RUNS QUALITY CONTROL (QC) ONCE DAILY AND REPORTED NO QUALITY CONTROL (QC) ISSUES. OTHER SYSTEM PERFORMANCE INDICATORS SUC

  Patient problems: No Code Available

  MAUDE report 9306373 ↗
• InjuryNov 7, 2019High Test Results; High Test Results

  ON 28OCT2019, THE CUSTOMER REPORTED THAT ON (B)(6) 2019 AN ERRONEOUS ELEVATED TROPONIN I (ACCESS ACCUTNI +3) RESULT WAS GENERATED FOR ONE PATIENT INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY SYSTEM PORTION OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM SERIAL NUMBER (B)(4). THE INITIAL RESULT OBTAINED WAS 1.03 NG/ML. THIS SAMPLE WAS REPEAT TESTED AND A RESULT OF 1.12 NG/ML WAS OBTAINED ON (B)(6) 2019. THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT. THE CUSTOMER REPORTED THAT THE PATIENT UNDERWENT A TREADMILL NUCLEAR STRESS TEST, EKG AND A GATED SPECT SCAN. THE PATIENT WAS ALSO TREATED WITH ASPIRIN AND SUBLINGUAL NITROGLYCERINE. THE CUSTOMER WAS UNABLE TO PROVIDE ADDITIONAL DETAILS TO CONFIRM IF THESE CHANGES TO TREATMENT WERE BASED SOLELY ON THE ELEVATED ACCESS ACCUTNI PATIENT RESULTS. THE CUSTOMER IS USING A REFERENCE RANGE OF 0.00 - 0.03 NG/ML. THE BECKMAN COULTER REFERENCE RANGE IS 0.00 - 0.04 NG/ML. THE LABORATORY NOTED NO ISSUES WITH QUALITY CONTROL. OTHER SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECKS AND CALIBRATIONS WERE REQUESTED BUT WERE NOT PROVIDED FOR EVALUATION. THE PATIENT'S SAMPLE WAS COLLECTED IN A 13X75 GREEN TOP BECTON DICKINSON (BD) BRAND TUBE

  Patient problems: No Code Available

  MAUDE report 9291201 ↗