TRIAGE CARDIAC TRIPLE MARKER PANEL

Additional Manufacturer Narrative

INVESTIGATION CONCLUSION: CUSTOMER'S COMPLAINT WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAIN LOT W61662. NO ISSUES WITH TNI WERE OBSERVED. MANUFACTURING BATCH RECORDS FOR LOT W61662 WERE REVIEWED AND FOUND THAT THE LOT MET RELEASE SPECIFICATIONS. FURTHER INVESTIGATION WAS NOT POSSIBLE SINCE THE CUSTOMER DID NOT RETURN ANY SAMPLES FOR TESTING. UNABLE TO DETERMINE A ROOT CAUSE FROM THE AVAILABLE INFORMATION. PRODUCT DEFICIENCY WAS NOT ESTABLISHED.

Description of Event or Problem

REPORT RECEIVED OF DISCREPANT LOW TNI X2 ON ONE METER/ 1 LOT/ 1 PATIENT . AN (B)(6) PATIENT ADMITTED TO EMERGENCY ROOM AFTER HE HAD FALLEN AND WAS DISORIENTED PATIENT DIAGNOSED WITH A.FIB AND OTHER CARDIAC ABNORMALITIES. NO ACUTE MI. ON (B)(6) 2016: 1ST CORRELATION: TRIAGE=<0.05, VISTA DIMENSION=0.14, 0.15. ON (B)(6) 2016: 2ND CORRELATION: TRIAGE=<0.05, VISTA DIMENSION=0.20. THREE HOURS BETWEEN CORRELATIONS. REFERENCE RANGE FOR DIMENSION: 0-0.05. CUT-OFF NOT PROVIDED. TESTING FOR TNI ON BOTH INSTRUMENTS. PATIENT WAS STARTED ON HEPARIN AFTER FIRST RESULT RECEIVED ON TRIAGE/VISTA DIMENSION. AS OF THIS REPORT DATE, PATIENT HAD NOT BEEN DISCHARGED; NO CURRENT DIAGNOSIS. NO ADDITIONAL INFORMATION PROVIDED.