KIT, TRIAGE, CARDIAC TNI/CKMB

Additional Manufacturer Narrative

INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

Description of Event or Problem

CALLER ALLEGING FN TNI - TRIAGE METER VS. BECKMAN ACCESS. ON (B)(6) 2015 A (B)(6) MALE PRESENTED WITH "I CAN'T BREATHE". PATIENT HAS A CARDIAC HISTORY AND USE OF DEFIBRILLATOR. ST ELEVATION. PATIENT DIAGNOSED WITH PULMONARY EMBOLISM. (B)(6). CUSTOMER STATED THAT THERE IS A POSSIBLE ISSUE WITH THE BECKMAN. NO ADVERSE EVENTS RELATED TO THE TRIAGE RESULT. NO ADDITIONAL INFORMATION PROVIDED.

Additional Manufacturer Narrative

INVESTIGATION CONCLUSION UPDATE: CUSTOMERS COMPLAINT WAS REPLICATED WITH RETURNED SAMPLES. RETURNED SAMPLES YIELDED TNI <0.05NG/ML ON LOT W59737. PATIENT WAS NOT DIAGNOSED WITH A CARDIAC EVENT. CLINICAL OUTCOME IS CONSISTENT WITH TRIAGE RESULT. AFTER INVESTIGATION, NO DISCREPANT TNI RESULTS WERE OBSERVED WITH IN-HOUSE TESTING OF RETAIN LOT W59737RB. THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED. THE PRODUCT PERFORMED AS EXPECTED. CUSTOMER DID NOT RETURN ANY SAMPLE; UNABLE TO RULE OUT SAMPLE SPECIFIC INTERFERENCE AS A POTENTIAL CAUSE OF THE COMPLAINT. BATCH RECORDS FOR LOT W59737RB WERE REVIEWED AND FOUND NO RELEVANT NCS AND/OR TIFS. THIS PRODUCT PASSED ALL SPECIFICATIONS FOR FINAL LOT RELEASE. CUSTOMER DID NOT RUN SAMPLES SIDE BY SIDE ON BOTH ANALYZERS, WHICH MAY CAUSE DISCREPANT RESULTS BETWEEN THE ANALYZERS. AS OF 8/3/15, THERE HAVE BEEN ONLY 2 DISCREPANT COMPLAINTS FOR CARDIAC LOT W59737RB. NO PRODUCT DEFICIENCY WAS ESTABLISHED.