TRIAGE CARDIAC PANEL 25 TEST

Additional Manufacturer Narrative

NO DISCREPANT LOW TNI RESULTS OBSERVED WITH IN-HOUSE TESTING OF RETAIN LOT W56189. 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. DEVICE LOT W56189 IS NOW EXPIRED. 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 (B)(6) WHILE VITROS 5600 SHOWS (B)(6). CONFIRMED ELEVATED WITH REFERENCE LAB TESTING WHICH IS ALSO A VITROS 5600 AND ABNORMAL EKGS. PT PRESENTED TO THE ER WITH CHEST PAIN. ALSO SHOWED ABNORMAL EKG AND WAS DIAGNOSED WITH ACUTE MI. A (B)(6) MALE; (B)(6) 2014, 20:09, RESULTED ON VITROS AT 0.178 AND NEXT DAY ((B)(6) 2014, 06:25) TESTED ON TRIAGE METER AT <0,05. RETESTED ON VITROS AT 18:20 WITH A RESULT OF 0.157. THE METER WAS PUT INTO SERVICE AS BACKUP TO ANALYZER IN (B)(4) 2014, SO CVS PERFORMED CORRECTLY AT THIS TIME. VITROS 5600, USE LITHIUM PLASMA SAMPLES. RESULTS OF <0.02 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. USE WB EDTA. PT HAS BEEN DISCHARGED. NO OTHER RESULTS ARE AVAILABLE, SUCH AS ANGIOGRAM BECAUSE CALLER IS UNSURE IF THE TEST WAS PERFORMED. NO STRESS TEST PERFORMED. NO ADD'L INFO AVAILABLE.