ARCHITECT CEA

Additional Manufacturer Narrative

NO RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE FOR THIS EVALUATION. ACCURACY TESTING WAS PERFORMED USING IN-HOUSE RETAINED REAGENTS OF LOT 49196LF00. REPLICATES OF A SERUM BASED PANEL WERE TESTED ON ONE ARCHITECT I-SYSTEM. ALL RESULTS FELL WITHIN SPECIFICATIONS, INDICATING ACCEPTABLE PERFORMANCE OF THIS ASSAY LOT. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT CEA ASSAY PACKAGE INSERT AND THE ARCHITECT SYSTEM OPERATIONS MANUAL CONTAIN INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE AVAILABLE INFORMATION FROM THE CUSTOMER SITE AND FROM THE RESULTS OF THIS EVALUATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST A PRODUCT MALFUNCTION OCCURRED. THE SUSPECTED LOW RESULT IS FOR A DISCRETE PATIENT SAMPLE AND THE RE-TEST OF THE SAMPLE ON THE SAME INSTRUMENT AND WITH THE SAME REAGENT LOT AND SERIAL NUMBER GAVE THE EXPECTED RESULT. THE INITIAL LOW CEA VALUE IS POTENTIALLY DUE TO SAMPLE DRAW, PREPARATION OR HANDLING AT THE TIME OF TESTING.

Description of Event or Problem

THE CUSTOMER REPORTS THAT ONE PATIENT SAMPLE GENERATED AN INITIAL ARCHITECT CEA ASSAY RESULT OF 0.00 NG/ML. THE SAMPLE WAS RETESTED AND GENERATED A RESULT OF 4.75 NG/ML. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB WITH NO PATIENT IMPACT.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).