TRIAGE CARDIAC PANEL 25 TEST

Additional Manufacturer Narrative

SEPARATE MEDWATCH FORMS ((B)(4)) ARE BEING SUBMITTED FOR PATIENT 2, LOT # W59052B; ((B)(4)) ARE BEING SUBMITTED FOR PATIENT 1, LOT # W58575B; ((B)(4)) ARE BEING SUBMITTED FOR PATIENT 2, LOT # W58575B. INVESTIGATION PENDING.

Description of Event or Problem

CUSTOMER WAS RUNNING PATIENT COMPARISONS FROM THEIR DIMENSION EXL TO THEIR TRIAGE MONITOR WHICH IS USED FOR BACK UP. CUSTOMER RUNS 5 PATIENT SAMPLE COMPARISONS APPROXIMATELY EVERY 6 MONTHS AND IS REPORTING DISCREPANT LOW TNI RESULTS ON TWO PATIENTS. CUSTOMER RECEIVED TROPONIN I (TNI) RESULT OF <0.05 ON TWO PATIENTS TWO TIMES EACH, TESTING BOTH PLASMA AND WB EDTA ON BOTH PATIENTS (EACH PATIENT WAS TESTED ON TWO DIFFERENT LOTS OF DEVICE (W59052B AND W58575B). DRAW TIMES FOR SPECIMENS UNKNOWN. CUSTOMER RUNS PLASMA ON THE HOSPITAL'S ANALYZER. BOTH PATIENTS RECEIVED A 0.10 ON THE DIMENSION EXL. THE HOSPITAL ANALYZER'S CUTOFF IS <0.02. PATIENT 1: BEING SCREENED IN THE ED FOR CARDIAC MARKERS, ADMITTED TO HOSPITAL. CUSTOMER DID NOT HAVE ANY FURTHER DETAILS ON THE INITIAL REASON FOR VISIT TO THE ED. PATIENT 2: CUSTOMER STATES THAT PATIENT WAS PROBABLY BEING SCREEN FOR CARDIAC MARKERS FOR UNKNOWN REASON TO THE ED, SHE DOES NOT THINK THAT PATIENT WAS ADMITTED TO THE HOSPITAL. ALERE CONTROLS AND CALVERS PASSING. BIORAD CONTROLS RUN ON THE DIMENSION - NO ISSUES WITH BIORAD CONTROLS. NO ISSUES WITH RESULTS FROM CKMB AND MYO FOR BOTH PATIENTS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO FURTHER INFORMATION WAS PROVIDED. THIS MEDWATCH IS SUBMITTED FOR PATIENT 1 AND LOT # W59052B.