ARCHITECT CEA

Additional Manufacturer Narrative

LOT/SERIAL NUMBER WAS NOT PROVIDED BY THE CUSTOMER; THEREFORE, ONLY A PARTIAL UDI IS KNOWN AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY DEPRESSED CARCINOEMBRYONIC ANTIGEN (CEA) RESULT ON THE ARCHITECT I1000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL 55.7 NG/ML, REPEAT 2.6. THERE WAS NO IMPACT TO THE PATIENT MANAGEMENT OF THIS (B)(6) MALE PATIENT BEING TREATED FOR SIGMOID COLON CANCER.

Additional Manufacturer Narrative

FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF FIELD DATA, AND A REVIEW OF LABELING. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. HISTORICAL PERFORMANCE OF ALL OF THE ON-MARKET REAGENT LOTS WERE EVALUATED USING WORLD WIDE DATA. THE PATIENT DATA WAS ANALYZED AND WITHIN ESTABLISHED CONTROL LIMITS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.