TRIAGE CARDIAC PANEL 25 TEST

Additional Manufacturer Narrative

NO DISCREPANT LOW TNI RESULTS OBSERVED WITH IN-HOUSE TESTING OF RETAIN LOT W57740. NO NC'S OR TIF'S RELATED TO THE COMPLAINT LOT. SAMPLE WILL NOT BE RETURNED, SAMPLE INTERFERENCE CANNOT BE RULED OUT. UNABLE TO DETERMINE ROOT CAUSE OF COMPLAINT. PRODUCT PERFORMED AS EXPECTED. NO ISSUES WITH DEVICE RECOVERY OBSERVED. AS THERE IS NO INDICATION OF A PRODUCT DEFICIENCY, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

Description of Event or Problem

CALLER ALLEGING RECEIVING DISCREPANT TRIAGE METER TNI RESULT SHOWING NEGATIVE WHILE VITROS 5600 SHOWS POSITIVE. CONFIRMED ELEVATED WITH REFERENCE LAB TESTING WHICH IS ALSO A VITROS 5600 AND ABNORMAL EKG. PT PRESENTED TO THE ER WITH CHEST PAIN. ALSO SHOWED ABNORMAL EKG AND WAS DIAGNOSED WITH ACUTE MI. AN (B)(6) FEMALE; (B)(6) 2014, 04:53, RESULTED ON VITROS AT 0.114 AND 11:25 AT 0.276 AT REFERENCE LAB WHICH ALSO USES THE VITROS 5600. TESTED ON METER ON (B)(6) 2014 AT 06:20 AT <0.05. METER WAS PUT INTO SERVICE AS BACKUP TO ANALYZER IN (B)(6) 2014, SO CVS PERFORMED CORRECTLY AT THIS TIME. VITROS 5600, USES LITHIUM PLASMA SAMPLES. RESULTS OF <0.012 ARE CONSIDERED NEGATIVE. AMI CUTOFF IS 0.120 WITH A RANGE OF <0.034. TRIAGE METER, 0.05 TO 0.4 IS GRAY ZONE, WITH <0.05 CONSIDERED NEGATIVE, USES WB EDTA. PT STILL BEING TREATED AS OF (B)(6) 2014. NO OTHER RESULTS ARE AVAILABLE, SUCH AS ANGIOGRAM, CALLER UNSURE IF TEST WAS PERFORMED. NO STRESS TEST PERFORMED. ALTHOUGH ATTEMPTS WERE MADE TO OBTAIN ADD'L PT INFO, THEY WERE UNSUCCESSFUL. NO ADD'L INFO AVAILABLE.