Access AccuTnI+3 A98264Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 15099590209353), received between Oct 7, 2016 and Sep 30, 2026 — classified as 47 injuries, 10 malfunctions.

The most frequently reported specific device problem is “High Test Results” (52 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 59 reports, 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 ↗
• 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 ↗
• 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 ↗
• InjuryJul 6, 2021High Test Results; High Test Results

  ON (B)(6) 2021 THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE FALSE HIGH TROPONIN I (ACCESS ACCUTNI+3, PART NUMBER A98264, LOT NUMBER 922912) RESULTS INVOLVING THE LABORATORY'S DXI 600 ACCESS IMMUNOASSAY W/DUAL GANTRY ANALYZERS (SERIAL NUMBER (B)(4) AND (B)(4)). CUSTOMER NOTED THAT THEY HAVE REPORTED ERRONEOUS RESULTS OUT OF THE LAB. NO DATA WAS PROVIDED. THE CUSTOMER REPORTED THAT ONE PATIENT TREATMENT WAS CHANGED AND THE PATIENT RECEIVED AN UNNECESSARY CATHETERIZATION. CUSTOMER COULD NOT PROVIDE ANY MORE SPECIFICS REGARDING PATIENT THAT WAS TREATED AND COULD NOT SPECIFY ON WHICH INSTRUMENT THE ERRONEOUS RESULTS OCCURRED FOR THIS PATIENT. NO FURTHER DETAILS WERE PROVIDED. PASSING SYSTEM CHECK WAS OBTAINED ON (B)(6) 2021 FOR BOTH INSTRUMENTS. CALIBRATION PASSED ON 05MAY2021 USING REAGENT LOT 922912 AND CALIBRATOR LOT 922452 FOR INSTRUMENT SERIAL NUMBER (B)(4). CALIBRATION WAS OBTAINED ON 30APR2021 USING REAGENT LOT 922912 AND CALIBRATOR LOT 922452 FOR INSTRUMENT SERIAL NUMBER (B)(4). PRECISION RUN WAS PERFORMED ON (B)(6) 2021 WITH NO ISSUES ON BOTH INSTRUMENTS. SAMPLE TUBE COLLECTION TYPE WAS A BD RAPID SEPARATOR TUBES SEIZE 13*100. THE CUSTOMER REPORTED THAT SAMPLE WAS CENTRIFUG

  Patient problems: Insufficient Information

  MAUDE report 12120321 ↗
• InjuryJun 15, 2021High Test Results; High Test Results

  ON (B)(6) 2021, THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE ERRONEOUS ELEVATED TROPONIN I (ACCUTNI+3 FOR USE ON DXI, PART NUMBER A98264, AND LOT NUMBER 922912) RESULTS, GENERATED ON THE CUSTOMER'S DXI (DXI 600 ACCESS IMMUNOASSAY ANALYZER, PART NUMBER A30260 AND SERIAL NUMBER (B)(4)) FOR AN UNKNOWN NUMBER OF PATIENTS. THE CUSTOMER WAS UNABLE TO PROVIDE SPECIFIC DATES OR SAMPLE RECOVERY DETAILS FOR THOSE PATIENT RESULTS. THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER THE PATIENTS WERE HELD LONGER IN THE HOSPITAL FOR MONITORING AND TESTING; THE CUSTOMER ALSO REPORTED THE PATIENTS WERE ADMITTED TO BE TREATED FOR MYOCARDIAL INFARCTION (MI). THE CUSTOMER WAS UNABLE TO PROVIDE SPECIFIC DETAILS REGARDING TREATMENT PROVIDED TO PATIENTS. THE CUSTOMER DID CONFIRM NO DEATH OR INJURY OCCURRED IN CONNECTION WITH THE EVENT. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. ALTHOUGH THE CUSTOMER DATA INCLUDED A SYSTEM CHECK WHICH FAILED THE UNWASHED PORTION, REPEATING THE SYSTEM CHECK WITH FRESH SYSTEM CHECK SOLUTION YIELDED A PASSING SYSTEM CHECK. OVERALL, SYSTEM PERFORMANCE INDICATORS SU

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

  MAUDE report 12001767 ↗
• InjuryJun 2, 2021High Test Results; High Test Results

  ON (B)(6) 2021, THE CUSTOMER REPORTED OBTAINING REPRODUCIBLE FALSE ELEVATED TROPONIN I (ACCESS ACCUTNI+3, PART NUMBER A98264 AND LOT NUMBER 922065) RESULTS FOR ONE PATIENT INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(4)). THE INITIAL ACCUTNI+3 PATIENT RESULT WAS >84 NG/ML (THE MYOCARDIAL INFARCTION (MI) CUTOFF IS 0.03 NG/ML) WHILE ECG (ELECTROCARDIOGRAM) RESULT WAS NORMAL AND OTHER CARDIAC ASSAYS (CK-MB, CK AND MYOGLOBIN) RESULTS WERE WITHIN THE NORMAL REFERENCE RANGES AND DISCORDANT WITH THE ACCUTNI+3 RESULTS OBTAINED. THE CUSTOMER RECENTRIFUGED THE SAMPLE AND RETESTED IT WITH THE SAME RESULT OF >84 NG/ML. THE INITIAL AND THE RECENTRIFUGED SAMPLE WERE ALSO TESTED WITH THE HSTNI ASSAY WITH EXPECTED NORMAL RESULTS (0.0089 NG/ML AND 0.0078 NG/ML) AND ON AN ALTERNATE METHODOLOGY (RADIOMETER) WITH ACCEPTABLE NORMAL RESULTS WHICH WERE ALSO DISCORDANT WITH THE ACCESS ACCUTNI+3 RESULTS (DATA NOT PROVIDED). THE CUSTOMER REPORTED THAT THE PATIENT SURGERY (CHOLECYSTECTOMY) WAS SUSPENDED AND DELAYED FOR ABOUT HALF A DAY DUE TO THE FALSE HIGH ACCUTNI+3 RESULTS. NO SYSTEM CHECK, NO QUALITY CONTROL AND NO CALIBRATION DATA WERE PR

  Patient problems: Insufficient Information

  MAUDE report 11921446 ↗
• InjuryMay 3, 2021High Test Results; High Test Results

  ON (B)(6) 2021 THE CUSTOMER REPORTED OBTAINING FALSE NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI+3) RESULT FOR ONE PATIENT INVOLVING THE LABORATORY'S DXI 800 ACCESS IMMUNOASSAY W/SPOT B ANALYZER (SERIAL NUMBER (B)(4)). DESPITE MULTIPLE ATTEMPT HAVE BEEN MADE TO GET ADDITIONAL INFORMATION ON PATIENT RESULTS, NO ADDITIONAL INFORMATION WAS PROVIDED. ONE PATIENT WAS SENT TO THE CATHETERIZATION LABORATORY BUT, DESPITE MULTIPLE ATTEMPT, IT IS UNKNOWN IF THE PATIENT HAS BEEN CATHETERIZED OR NOT. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. CALIBRATION PASSED ON (B)(6) 2021 WITH REAGENT LOT 922912 AND CALIBRATOR LOT 922646. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORYS ESTABLISHED RANGES. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER ON (B)(6) 2021 AND ADJUSTED ULTRASONICS. HE RAN 100 REPETITIONS OF TROPONIN USING WASH BUFFER AS SAMPLE AND DID NOT OBTAIN ANY FLYER. ANOTHER FSE WENT TO THE CUSTOMER SITE ON (B)(6) 2021 TO OBSERVE PRE-ANALYTICAL SPECIMEN HANDLING. HE INDICATED THAT NO PRE-ANALYTICAL ISSUE WAS SEEN WITH NO FIBRIN OR CELLULAR DEBRIS WITHIN SAMPLES. THE CUSTOMER IS RUNNING ALL ACCUTNI+3 PATIENT

  Patient problems: Insufficient Information

  MAUDE report 11759910 ↗
• InjuryApr 16, 2021High Test Results; High Test Results

  ON 08APR2021 THE CUSTOMER REPORTED A NON-REPRODUCIBLE ELEVATED TROPONIN I RESULT (ACCESS ACCUTNI +3 ASSAY, PART NUMBER A98264 AND LOT NUMBER 922912) WERE GENERATED ON THE CUSTOMER'S DXI 600 (DXI 600 ACCESS IMMUNOASSAY ANALYZER, PART NUMBER A71460 AND SERIAL NUMBER (B)(4)) ON 06APR2021. THE CUSTOMER DID NOT PROVIDE SPECIFIC RESULT OBTAINED BUT STATED THE RESULT, ABOVE CUSTOMER UPPER REFERENCE LIMIT (URL) OF <0.04 NG/ML, WAS REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER REPORTED A CHANGE TO PATIENT CARE OR TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPORTED ONE PATIENT WAS ADMITTED AND RECEIVED A CHEST CT SCAN WITH DYE, X-RAYS AND AN EKG. THE PATIENT WAS RELEASED AFTER CORRECTED TROPONIN I RESULTS WERE OBTAINED. SPECIFIC DETAILS REGARDING TROPONIN I, CT, X-RAY AND EKG RESULTS WERE NOT PROVIDED. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL (QC) WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. SAMPLE WAS A LITHIUM HEPARIN PLASMA SAMPLE AND PROCESSED USING CUSTOMER'S AUTOMATION LINE. CENTRIFUGATION CONDITIONS WERE NOT PROVIDED BY T

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

  MAUDE report 11681384 ↗
• InjuryMar 12, 2021High Test Results; High Test Results

  ON (B)(6) 2021 THE CUSTOMER REPORTED OBTAINING REPRODUCIBLE ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULTS FOR ONE PATIENT INVOLVING THE LABORATORY'S UNICEL DXI 800 ANALYZER IMMUNOASSAY (SERIAL NUMBER (B)(4)). ONE PATIENT WAS ADMITTED ON (B)(6) 2021 AND HAD NORMAL BLOOD PRESSURE ON ADMISSION BUT THE ELECTROCARDIOGRAM SHOWED HIGH VOLTAGE ON THE LEFT VENTRICULAR SURFACE. CUSTOMER REPORTED THAT THE TROPONIN RESULTS FOR THIS PATIENT USED TO BE BEYOND THE NORMAL REFERENCE RANGE (>0.04 NG/ML) BUT THE ACCUTNI+3 RESULTS HAD INCREASED. THE UNEXPECTED INITIAL PATIENT SAMPLE RESULTS REPORTED WERE 1.596 NG/ML AND 1.797 NG/ML. THE PATIENT WAS RETESTED ON (B)(6) 2021 WITH A RESULT OF 1.782 NG/ML AND ON (B)(6) 2021 WITH A RESULT OF 1.583 NG/ML. CUSTOMER RUN SAMPLE PATIENT ON DIFFERENT PLATFORMS. THE ACCESS ACCUTNI+3 RESULTS WERE DISCORDANT WITH THE ACCESS HSTNI RESULTS WITH A LOW RESULT OF 0.00 NG/ML ON (B)(6) 2021, WITH THE VIDAS METHODOLOGY WITH A LOW RESULT OF <0.01 NG/ML (DATA NOT PROVIDED) AND WITH THE ROCHE METHODOLOGY WITH A LOW RESULT OF <0.005 NG/ML (DATA NOT PROVIDED). THE CUSTOMER REPORTED DELAYED TREATMENT DUE TO THE ELEVATED ACCESS ACCUTNI+3 RESULTS. PATIENT WAS WAITING FOR THE SEVEN

  Patient problems: Insufficient Information

  MAUDE report 11472084 ↗
• InjuryFeb 7, 2021High Test Results; High Test Results

  ON (B)(6) 2021 THE CUSTOMER REPORTED NON-REPRODUCIBLE ELEVATED TROPONIN I (ACCESS ACCUTNI +3 ASSAY, PART NUMBER A98264 AND LOT NUMBER 922466) WERE GENERATED ON THE CUSTOMER'S DXI 600 (DXI 600 ACCESS IMMUNOASSAY ANALYZER, PART NUMBER A71461 AND SERIAL NUMBER (B)(4)) FOR AN UNKNOWN NUMBER OF PATIENTS. THE CUSTOMER DID NOT PROVIDE NUMBER OF PATIENTS OR RESULTS OBTAINED FOR ANY PATIENTS. THE CCUSTOMER STATED A CRITICAL RESULT WOULD BE GENERATED ON THE DXI 600 AND WHEN TESTED ON THE CUSTOMER'S OTHER DXI 600 (SERIAL NUMBER (B)(4)) THE RESULT WOULD BE WITHIN THE CUSTOMER'S NORMAL RANGE. CUSTOMER STATED CRITICAL CUTOFF FOR THE TROPONIN I ASSAY WAS >0.04 NG/ML. CUSTOMER ALSO STATED THAT REPEATING SAMPLE TESTING ON THEIR ISTAT DEVICE WOULD GIVE A "NEGATIVE" RESULT. NO PATIENT DATA WAS PROVIDED. ON (B)(6) 2021 THE CUSTOMER REPORTED A CHANGE TO PATIENT CARE OR TREATMENT IN CONNECTION WITH THIS EVENT; THE CUSTOMER STATED THAT PATIENTS WERE ADMITTED TO THE HOSPITAL AND TREATMENT WAS ADMINISTERED. THE CUSTOMER DID NOT REPORT SPECIFIC TREATMENTS ADMINISTERED. THE CUSTOMER DID NOT PROVIDE FURTHER INFORMATION REGARDING PATIENT CARE OR TREATMENT. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE RE

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

  MAUDE report 11290502 ↗
• InjuryFeb 7, 2021High Test Results; High Test Results

  ON (B)(6) 2021 THE CUSTOMER REPORTED NON-REPRODUCIBLE ELEVATED TROPONIN I (ACCESS ACCUTNI +3 ASSAY, PART NUMBER A98264 AND LOT NUMBER 922509) WERE GENERATED ON THE CUSTOMER'S DXI 600 (DXI 600 ACCESS IMMUNOASSAY ANALYZER, PART NUMBER A71461 AND SERIAL NUMBER (B)(4)) FOR AN UNKNOWN NUMBER OF PATIENTS. THE CUSTOMER DID NOT PROVIDE NUMBER OF PATIENTS OR RESULTS OBTAINED FOR ANY PATIENTS. THE CUSTOMER STATED A CRITICAL RESULT WOULD BE GENERATED ON THE DXI 600 AND WHEN TESTED ON THE CUSTOMER'S OTHER DXI 600 (SERIAL NUMBER (B)(4)) THE RESULT WOULD BE WITHIN THE CUSTOMER'S NORMAL RANGE. CUSTOMER STATED CRITICAL CUTOFF FOR THE TROPONIN I ASSAY WAS >0.04 NG/ML. CUSTOMER ALSO STATED THAT REPEATING SAMPLE TESTING ON THEIR ISTAT DEVICE WOULD GIVE A "NEGATIVE" RESULT. NO PATIENT DATA WAS PROVIDED. ON (B)(6) 2021 THE CUSTOMER REPORTED A CHANGE TO PATIENT CARE OR TREATMENT IN CONNECTION WITH THIS EVENT; THE CUSTOMER STATED THAT PATIENTS WERE ADMITTED TO THE HOSPITAL AND TREATMENT WAS ADMINISTERED. THE CUSTOMER DID NOT REPORT SPECIFIC TREATMENTS ADMINISTERED. THE CUSTOMER DID NOT PROVIDE FURTHER INFORMATION REGARDING PATIENT CARE OR TREATMENT. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REP

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

  MAUDE report 11290499 ↗
• InjuryOct 13, 2020High Test Results; High Test Results

  ON (B)(6) 2020 THE CUSTOMER REPORTED OBTAINING REPRODUCIBLE ERRONEOUSLY HIGH TROPONIN I (ACCESS ACCUTNI+3) RESULTS FOR ONE PATIENT INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (SERIAL NUMBER (B)(4)). ON (B)(6) 2020, ONE ACCUTNI+3 PATIENT SAMPLE RESULT WAS 29.48 NG/ML WHICH WAS ABOVE THE CUSTOMER'S REFERENCE RANGE (0-0.03 NG/ML). THE REPEAT RESULT WAS STILL HIGH AT 29.72 NG/ML. A CORONARY ANGIOGRAPHY WAS THEN PERFORMED DUE TO THE ELEVATED ACCESS ACCUTNI+3 RESULT, WHICH WAS NORMAL. THE SAMPLE WAS ALSO TESTED WITH THE ROCHE TNT ASSAY (0.006 NG/ML) AND THE XINGTONG MEDICAL TECHNOLOGY WITH BOTH NORMAL RESULTS (NO FURTHER INFORMATION PROVIDED). ON (B)(6) 2020 THE SAMPLE WAS ALSO TESTED WITH THE ACCESS HSTNI ASSAY. THE RESULT WAS NORMAL AT 4.095 PG/ML. A CORONARY ANGIOGRAPHY WAS PERFORMED DUE TO THE ELEVATED ACCESS ACCUTNI+3 RESULTS. THERE WAS NO ADDITIONAL CHANGE TO OR IMPACT TO PATIENT CARE REPORTED IN ASSOCIATION WITH THIS INCIDENT. ON (B)(6) 2020, A BECKMAN LABORATORY SOLUTION SPECIALIST (LSS) WAS DISPATCHED TO THE CUSTOMER SITE. THE LSS FIRST TESTED THE PATIENT SAMPLE NEAT FOR THE ACCUTNI+3 ASSAY AND OBTAINED A SIMILAR HIGH RESULT AT 25.56 NG/ML. AN INTERFERE

  Patient problems: Misdiagnosis

  MAUDE report 10670168 ↗
• InjuryJul 28, 2020High Test Results; High Test Results

  ON (B)(6) 2020 THE CUSTOMER REPORTED OBTAINING ONE NON-REPEATABLE FALSE HIGH TROPONIN I (ACCESS ACCUTNI+3) RESULT FOR ONE PATIENT INVOLVING THE LABORATORY'S DXI 800 ACCESS IMMASSY W/DUAL GANTRY ANALYZER (SERIAL NUMBER (B)(4)). ON (B)(6) 2020, THE SAMPLE PATIENT RESULTED INITIALLY AT 3.26 NG/ML AND UPON REPEAT THE DAY AFTER THE RESULT WAS LOW AT 0.01 NG/ML. CUSTOMER REPEATED THE SAMPLE TWICE ON (B)(6) 2020 WITH BOTH RESULTS OF 0.01 NG/ML. TWO OTHER SAMPLES FROM THE SAME PATIENT WERE TESTED ON (B)(6) 2020 WITH SIMILAR LOW RESULTS AT 0.01 NG/ML. THE CUSTOMER REFERENCE RANGE IS <0.03 NG/ML. THE CUSTOMER INDICATED THERE WAS CHANGE TO PATIENT TREATMENT BUT REFUSED TO PROVIDE PATIENT TREATMENT INFORMATION. HOWEVER THE CUSTOMER STATED THAT THERE WAS NO REPORT OF AN INJURY OR ILLNESS TO THE PATIENT ATTRIBUTABLE TO THE OUTPUT FROM THE DEVICE IN THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(6) 2020. THE FSE CHECKED THE INSTRUMENT AND FOUND SUBSTRATE HAD HIGH %CV AND RLU (RELATIVE LIGHT UNIT). ENGINEER ALSO FOUND WRONG SCREWS ON SLIDE PINS UNDER WASH ARM ASSEMBLY. ENGINEER PERFORMED SUBSTRATE DECONTAMINATION AND ADJUSTED LUMINOMETER LED R

  Patient problems: No Code Available

  MAUDE report 10331380 ↗
• MalfunctionJul 23, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 06JUL2020 THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI+3) RESULTS FOR ONE PATIENT INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNO ANALYZER (SERIAL NUMBER (B)(4)). THE INITIAL RESULT WAS 2.75 NG/ML. THE SAMPLE WAS REPEATED DUE TO THE INITIAL VALUE BEING ABOVE CUTOFF (0.03 NG/ML) AT 9.43 NG/ML. BECAUSE OF THE POOR REPRODUCIBILITY OF THE RESULT, THE SAMPLE WAS ALIQUOTED, RECENTRIFUGED AND RETESTED WITH THE FOLLOWING RESULTS: 1.57 NG/ML, 3.5 NG/ML, 1.65 NG/ML AND 2.63 NG/ML. THE SAMPLE WAS RUN ON OTHER DXI INSTRUMENT AND GAVE HIGHER RESULTS OF 5.8 NG/ML REPEATED AT 6.34 NG/ML. THESES TWO RESULTS FROM OTHER DXI ANALYZER WERE REPORTED OUT OF THE LABORATORY. CUSTOMER REPORTED THE PATIENT WAS BELIEVED TO HAVE ACUTE MI (MYOCARDIAL INFARCTION). NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. CALIBRATION, SYSTEM CHECKS AND CARRYOVER PASSED WITHIN SPECIFICATIONS. CALIBRATOR LOT WAS EXPIRED AT THE TIME OF THE EVENT (EXPIRATION DATE: 30JUNE2020). BEFORE AND AFTER THE EVENT, LEVEL 1 QC (QUALITY CONTROL) RECOVERED OVER 2 SD (STANDARD DEVIATIONS) BELOW THE CUSTOMER¿S STATED MEAN. LEVEL 2 AND LEVEL 3 RECOVERED WITHIN THE 2

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10313187 ↗
• InjuryApr 22, 2020High Test Results; High Test Results

  ON (B)(6) 2020, THE CUSTOMER REPORTED OBTAINING MULTIPLE REPRODUCIBLE ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULTS FOR ONE PATIENT INVOLVING THE LABORATORY'S UNICEL DXI 800 IMMUNOASSAY SYSTEM (PART NUMBER 973100 AND SERIAL NUMBER (SN) (B)(4). SAMPLES WERE COLLECTED AND TESTED ON THE CUSTOMER'S UNICEL DXI 800 SN (B)(4) OVER SEVERAL DAYS: (B)(6) 2020 (TROPONIN I RESULT OF 0.01 NG/ML); (B)(6) 2020 (TROPONIN I RESULT OF 0.12 NG/ML); (B)(6) 2020 (0.11 NG/ML); AND (B)(6) 2020 (0.12 NG/ML). THE CUSTOMER DID NOT PROVIDE A REFERENCE RANGE; THE BECKMAN COULTER ACCUTNI+3 REFERENCE RANGE IS 0.00 - 0.04 NG/ML. THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT WHICH OCCURRED IN CONNECTION WITH THIS EVENT. THE PATIENT UNDERWENT AN ANGIOGRAM (DATE NOT PROVIDED) DUE TO THE ELEVATED TROPONIN I RESULTS. RESULTS OF ANGIOGRAM TESTING WERE NORMAL. NO FURTHER INFORMATION WAS PROVIDED REGARDING CHANGE TO OR IMPACT TO PATIENT CARE WAS REPORTED IN CONNECTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK AND CALIBRATION WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. QUALITY CONTROL TESTING RESULTS WERE NOT PROVIDED FOR REVIEW. NO ISSUES WITH SAMPLE COLLECTI

  Patient problems: No Code Available

  MAUDE report 9987872 ↗
• InjuryMar 3, 2020High Test Results; High Test Results

  ON FEBRUARY 21, 2020 THE CUSTOMER REPORTED THAT A NON-REPRODUCIBLE ELEVATED ACCESS TROPONIN I (ACCESS ACCUTNI+3) RESULT OF 0.356 NG/ML WAS GENERATED ON THE LABORATORY'S DXI 800 IMMUNOASSAY ANALYZER (PART NUMBER A71456 AND SERIAL NUMBER (B)(4)) FOR ONE PATIENT AT APPROXIMATELY 06:30AM. THE INITIAL ELEVATED RESULT WAS RELEASED FROM THE LABORATORY. THE CUSTOMER REPORTED THAT THE PHYSICIAN QUESTIONED THE RESULT AND THE PATIENT WAS REDRAWN; THE REDRAWN SAMPLE WAS TESTED AT 08:30AM AND A RESULT OF 0.032 NG/ML WAS OBTAINED. THE CUSTOMER ALSO REPORTED THAT THE ORIGINAL SAMPLE WAS RETESTED AND A RESULT OF 0.056 NG/ML WAS OBTAINED. THE CUSTOMER DID NOT PROVIDE REFERENCE RANGES. THE BECKMAN COULTER ACCESS ACCUTNI+3 REFERENCE RANGE IS 0.00 - 0.04 NG/ML. CUSTOMER REPORTED TREATMENT WAS PROVIDED TO THE PATIENT BUT CUSTOMER COULD NOT PROVIDE DETAILS OF TREATMENT ADMINISTERED. A WRITTEN ATTEMPT WAS MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING TREATMENT BUT TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. CALIBRATION, QUALITY CONTROL AND SYSTEM CHECK PARAMETERS WERE ALL RECOVERING WITH EXPECTED RANGES AT THE TIME OF THE EVENT. SAMPLES WERE COLLECTED IN BECTON DICKINSON (BD)'S GREEN TOP LITHI

  Patient problems: No Code Available

  MAUDE report 9781097 ↗
• InjuryJan 30, 2020High Test Results; High Test Results

  ON 15JAN2020, THE CUSTOMER REPORTED THAT ON (B)(6) 2020 AT 23:58, A REPRODUCIBLE ELEVATED TROPONIN I (ACCESS ACCUTNI +3) RESULT OF 0.128 NG/ML WAS GENERATED ON THE LABORATORY'S DXI 600 IMMUNOASSAY ANALYZER (PART NUMBER A71460 AND SERIAL NUMBER (B)(4)) FOR ONE PATIENT. THE INITIAL ELEVATED RESULT WAS REPORTED OUT OF THE LABORATORY. THE CUSTOMER'S TROPONIN I (ACCESS ACCUTNI +3) REFERENCE RANGE IS <0.03 NG/ML. THE SAMPLE WAS ALSO TESTED FOR TROPONIN USING AN I-STAT DEVICE; A RESULT 0.00 NG/ML WAS OBTAINED. THE CUSTOMER'S I-STAT TROPONIN REFERENCE RANGE IS 0.00 - 0.08 NG/ML. THERE WAS A REPORT OF CHANGE TO PATIENT CARE OR TREATMENT WHICH OCCURRED IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE ELEVATED TROPONIN RESULTS AND UNCONTROLLED BLOOD PRESSURE. THE PATIENT WAS TREATED MEDICALLY FOR THESE SYMPTOMS IN THE EMERGENCY ROOM AND ADMITTED FOR CARDIAC EVALUATION AND POSSIBLE STRESS TEST. CARDIOLOGY CONSULT COMPLETED (B)(6) 2020 FOR NONSTEMI (NON-ST SEGMENT ELEVATED MYOCARDIAL INFARCTION) AND HYPERTENSIVE EMERGENCY. EKG (ELECTROCARDIOGRAM) AND ECHOCARDIOGRAM WERE COMPLETED AND PATIENT HAD LEXISCAN STRESS TEST PERFORMED (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9646866 ↗
• InjuryAug 6, 2019High Test Results; High Test Results

  THE CUSTOMER CONTACTED BECKMAN COULTER (BCI) TO REPORT OBTAINING A NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI+3) RESULT FOR ONE (1) PATIENT ON THE LABORATORY'S UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4). THE INITIAL RESULT OBTAINED WAS ABOVE THE ACCESS ACCUTNI+3 ASSAY'S NORMAL REFERENCE RANGE AND WAS REPORTED FROM THE LABORATORY. SUBSEQUENT TESTING OF A SECOND SAMPLE FROM THE PATIENT ON ANOTHER ANALYZER (METHODOLOGY UNKNOWN) PRODUCED A SIGNIFICANTLY LOWER TROPONIN I RESULT WITHIN THE ASSAY'S NORMAL REFERENCE RANGE. THERE WAS A CHANGE TO PATIENT CARE/MANAGEMENT AS THE PATIENT IN QUESTION WAS ADMINISTERED AN ANTICOAGULANT THERAPY AS A RESULT OF THE INITIAL, ELEVATED ACCESS ACCUTNI+3 RESULT. THERE WAS NO REPORT OF DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER REPORTED THAT BOTH THE ACCESS ACCUTNI+3 QUALITY CONTROL (QC) AND THE BETA-HUMAN CHORIONIC GONADOTROPIN (ACCESS BHCG5) QC WERE PERFORMING ERRATICALLY AROUND THE TIMEFRAME OF THE REPORTED NON-REPRODUCIBLE RESULT. ADDITIONALLY, TWO (2) ACCESS ACCUTNI+3 CALIBRATION CURVES FAILED IN CONJUNCTION WITH THIS EVENT. A PASSING ACCESS ACCUTNI+3 CURVE WAS EVENTUALLY OBTAINED ALONG WITH A PASSING ACCESS BHCG5 CALIBRATION C

  Patient problems: No Code Available

  MAUDE report 8864991 ↗
• InjuryAug 6, 2019High Test Results; High Test Results

  THE CUSTOMER CONTACTED BECKMAN COULTER (BCI) TO REPORT OBTAINING A NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI+3) RESULT FOR ONE (1) PATIENT ON THE LABORATORY'S UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4). THE INITIAL RESULT OBTAINED WAS ABOVE THE ACCESS ACCUTNI+3 ASSAY'S NORMAL REFERENCE RANGE AND WAS REPORTED FROM THE LABORATORY. SUBSEQUENT TESTING OF THE SAME SAMPLE FROM THE PATIENT ON ANOTHER ANALYZER (METHODOLOGY UNKNOWN) PRODUCED A SIGNIFICANTLY LOWER TROPONIN I RESULT WITHIN THE ASSAY'S NORMAL REFERENCE RANGE. THERE WAS A CHANGE TO PATIENT CARE/MANAGEMENT AS THE PATIENT IN QUESTION WAS ADMINISTERED AN ANTICOAGULANT THERAPY AS A RESULT OF THE INITIAL, ELEVATED ACCESS ACCUTNI+3 RESULT. THERE WAS NO REPORT OF DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER REPORTED THAT BOTH THE ACCESS ACCUTNI+3 QUALITY CONTROL (QC) AND THE BETA-HUMAN CHORIONIC GONADOTROPIN (ACCESS BHCG5) QC WERE PERFORMING ERRATICALLY AROUND THE TIMEFRAME OF THE REPORTED NON-REPRODUCIBLE RESULT. ADDITIONALLY, TWO (2) ACCESS ACCUTNI+3 CALIBRATION CURVES FAILED IN CONJUNCTION WITH THIS EVENT. A PASSING ACCESS ACCUTNI+3 CURVE WAS EVENTUALLY OBTAINED ALONG WITH A PASSING ACCESS BHCG5 CALIBRATION C

  Patient problems: No Code Available

  MAUDE report 8864577 ↗
• InjuryAug 6, 2019High Test Results; High Test Results

  THE CUSTOMER CONTACTED BECKMAN COULTER (BCI) TO REPORT OBTAINING A NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI+3) RESULT FOR ONE (1) PATIENT ON THE LABORATORY'S UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4). THE INITIAL RESULT OBTAINED WAS ABOVE THE ACCESS ACCUTNI+3 ASSAY'S NORMAL REFERENCE RANGE AND WAS REPORTED FROM THE LABORATORY. SUBSEQUENT TESTING OF A SECOND SAMPLE FROM THE PATIENT ON ANOTHER ANALYZER (METHODOLOGY UNKNOWN) PRODUCED A SIGNIFICANTLY LOWER TROPONIN I RESULT WITHIN THE ASSAY'S NORMAL REFERENCE RANGE. THERE WAS A CHANGE TO PATIENT CARE/MANAGEMENT AS THE PATIENT IN QUESTION WAS ADMINISTERED AN ANTICOAGULANT THERAPY AS A RESULT OF THE INITIAL, ELEVATED ACCESS ACCUTNI+3 RESULT. THERE WAS NO REPORT OF DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER REPORTED THAT BOTH THE ACCESS ACCUTNI+3 QUALITY CONTROL (QC) AND THE BETA-HUMAN CHORIONIC GONADOTROPIN (ACCESS BHCG5) QC WERE PERFORMING ERRATICALLY AROUND THE TIMEFRAME OF THE REPORTED NON-REPRODUCIBLE RESULT. ADDITIONALLY, TWO (2) ACCESS ACCUTNI+3 CALIBRATION CURVES FAILED IN CONJUNCTION WITH THIS EVENT. A PASSING ACCESS ACCUTNI+3 CURVE WAS EVENTUALLY OBTAINED ALONG WITH A PASSING ACCESS BHCG5 CALIBRATION C

  Patient problems: No Code Available

  MAUDE report 8864327 ↗
• InjuryJul 16, 2019High Test Results; High Test Results

  THE CUSTOMER CONTACTED BECKMAN COULTER (BCI) TO REPORT OBTAINING REPRODUCIBLE, ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULTS FOR ONE PATIENT ON THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4). THE PATIENT'S SAMPLE INITIALLY RESULTED ABOVE THE NORMAL REFERENCE RANGE OF THE ACCESS ACCUTNI+3 ASSAY. BASED UPON THIS RESULT THE PHYSICIAN TREATED THE PATIENT (SEE BELOW). THE CUSTOMER THEN ANALYZED THE PATIENT'S SAMPLE ON AN ALTERNATE METHODOLOGY (MITSUBISHI) AND OBTAINED A DISCORDANT RESULT WITHIN THAT METHOD'S NORMAL REFERENCE RANGE. FURTHER TESTING OF THE SAMPLE ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM PRODUCED SIMILAR ELEVATED RESULTS TO THE FIRST RESULT OBTAINED. AS STATED ABOVE, THERE WAS A CHANGE TO PATIENT TREATMENT/MANAGEMENT AS THE PHYSICIAN ADMINISTERED A THROMBOLYTIC DRUG TO THE PATIENT. THE EXACT DRUG USED WAS NOT PROVIDED. THERE WAS NO REPORT OF ADDITIONAL INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDED QC (QUALITY CONTROL) OR SYSTEM CHECK DATA FOR REVIEW. HOWEVER, A PASSING ACCESS ACCUTNI+3 CALIBRATION WAS PROVIDED. THERE WERE NO REPORTS OF ISSUES WITH THE HARDWARE, OTHER ASSAYS OR OTHER PATIENT RESULTS IN CONJ

  Patient problems: No Code Available

  MAUDE report 8793775 ↗
• InjuryJul 15, 2019High Test Results; High Test Results

  ON (B)(6) 2019, THE CUSTOMER REPORTED THAT A NON-REPRODUCIBLE ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULT HAD BEEN GENERATED ON THE CUSTOMER'S UNICEL DXI 600 IMMUNOASSAY SYSTEM (PART NUMBER A30260 AND SERIAL NUMBER (B)(4)) FOR ONE PATIENT SAMPLE. THE INITIAL ELEVATED RESULT OF 0.23 NG/ML WAS RELEASED FROM THE LABORATORY. THE PATIENT WAS DRAWN FOR ADDITIONAL TROPONIN I TESTING; THE RESULT WAS 0.01 NG/ML. THE EMERGENCY DEPARTMENT (ED) CALLED THE LAB QUESTIONING THE FIRST RESULT OF 0.23 NG/ML WHEN THE NORMAL RESULT (0.01 NG/ML) OBTAINED FROM TESTING THE SECOND SAMPLE WAS RECEIVED. THE CUSTOMER RETESTED THE FIRST SAMPLE ON THE EVENT ANALYZER AND OBTAINED A RESULT OF 0.00 NG/ML. ON (B)(6) 2019, BOTH SAMPLES WERE TESTED ON A SECOND DXI 600 ANALYZER, PART NUMBER: A30260 AND SERIAL NUMBER: (B)(4). THE FIRST SAMPLE RESULT WAS 0.00 NG/ML AND THE SECOND SAMPLE RESULT WAS 0.01NG/ML. BOTH SAMPLES WERE RETESTED ON THE EVENT ANALYZER; THE FIRST SAMPLE REPEAT RESULT WAS 0.00 NG/ML AND THE SECOND SAMPLE REPEAT RESULT WAS 0.01 NG/ML. CUSTOMER PROVIDED REFERENCE RANGE IS 0.00 NG/ML - 0.04 NG/ML. THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT WHICH OCCURRED IN CONNECTION WITH THIS E

  Patient problems: No Code Available

  MAUDE report 8789699 ↗