TRIAGE CARDIAC TRIPLE MARKER PANEL

Additional Manufacturer Narrative

INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

Description of Event or Problem

RECEIVED EMAIL FROM THE EMERGENCY ROOM SAYING TRIAGE TROPONIN I WAS NEGATIVE AND THE CHEMISTRY ANALYZER POSITIVE FOR TROPONIN I. THE ISSUE OCCURRED ON (B)(6), 2015 IN WHICH THE TRIAGE REPORTED A TROPONIN I OF <0.05 AND THE BECKMAN DXI REPORTED THE TROPONIN I >0.034. THEIR NORMAL RANGE IS 0.00-0.034. PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAINS, SOB AND COUGHING UP BLOOD., THE REFERENCE RANGE AND CUT-OFFS OF ALL TESTS/ANALYZERS/METERS INVOLVED WERE AS FOLLOWS:. TRIAGE TNI: NORMAL = < 0.1 NG/ML; INDETERMINATE = 0.1 - 0.039; CRITICAL = >0.04. BECKMAN ACCESS TNI: CRITICAL = >0.04 NG/ML. FOLLOWING ARE THE TEST RESULTS AND DRAW/RUN TIMES FOR ALL ANALYTES: TNI: TRIAGE < 0.05, DXI >0.034 AS PROVIDED BY (B)(6). ALERE SCIENTIFIC AFFAIRS PROVIDED THE TEST RESULTS ON THESE DATES. SINCE (B)(6) 2015 TRIAGE TNI HAS BEEN < 0.05 ON ALL TESTS OF 17 DRAWS. ACCESS TNI RANGED FROM 0.084 INITIALLY ON (B)(6) 2015 AND TO 0.116 ON (B)(6) 2015 FROM 8 DRAWS. TRIAGE CKMB, MYO BELOW THRESHOLD. BNP FROM 233 TO 384. NO MEDICAL INTERVENTIONS WERE REPORTED BASED ON THE RESULTS. LAB TNI TEST WAS PERFORMED. EMERGENCY ROOM DIAGNOSIS WAS UNSTABLE ANGINA, ANGINA, ANXIETY. PATIENT WAS DISCHARGED FROM THE EMERGENCY ROOM WITH A DISCHARGE DIAGNOSIS OF CHEST PAIN AND WARFARIN OVERDOSE. NO DEATH OR INJURIES WERE REPORTED AS A RESULT OF THE "FALSE" TRIAGE TNI RESULT? NO ADDITIONAL INFORMATION PROVIDED.

Additional Manufacturer Narrative

INVESTIGATION CONCLUSION: RETAINED DEVICES TESTED WITH CAL J DID NOT PRODUCE LOW TNI RESULTS; CV RESULTS AT 9.1%, WHICH MEETS CARDIAC PRODUCT INSERT CLAIM. THE CUSTOMER'S COMPLAINT OF DISCREPANT LOW TNI WAS NOT REPLICATED. THE PRODUCT PERFORMED AS EXPECTED. BATCH RECORD REVIEW FOUND NO RELEVANT NCS OR TIFS; THIS PRODUCT PASSED ALL SPECIFICATIONS FOR FINAL LOT RELEASE. NO SAMPLE WAS RETURNED TO PRODUCT SUPPORT; CANNOT RULE OUT SAMPLE INTERFERENCE AS THE CAUSE OF THE COMPLAINT. NO PRODUCT DEFICIENCY WAS ESTABLISHED. ALERE TRIAGE DOES NOT HAVE A CLAIM TO CORRELATE WITH OTHER NON-ALERE ANALYZERS.