ADVIA CENTAUR CEA

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER REPORTED OBSERVATION OF AN ELEVATED CARCINOEMBRYONIC ANTIGEN (CEA) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING ON THE SAME ADVIA CENTAUR CP ANALYZER. SIEMENS HEALTHCARE DIAGNOSTICS HAS CONCLUDED THE INVESTIGATION OF THE EVENT. SIEMENS HAS EVALUATED THE INSTRUMENT DATA AND INFORMATION PROVIDED BY THE CUSTOMER. THE SAMPLE WAS CHECKED FOR INTEGRITY AND NO FIBRIN OR HIL INTERFERENCE WAS PRESENT. REAGENT OR INSTRUMENT ISSUES WERE RULED OUT BASED ON QUALITY CONTROL (QC) RECOVERY WITHIN ACCEPTABLE RANGES, SAMPLE RESULTS WERE REPEATABLE, AND NO ISSUES WERE REPORTED WITH OTHER PATIENT SAMPLES. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT COULD NOT BE DETERMINED. A PRODUCT PROBLEM HAS NOT BEEN IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ADVIA CENTAUR CARCINOEMBRYONIC ANTIGEN (CEA) RESULT FOR ONE PATIENT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS RETESTED ON THE ORIGINAL ANALYZER AND PRODUCED A LOWER RESULT. THIS LOWER REPEAT RESULT MATCHED THE PATIENT'S LAB HISTORY FOR CEA, AND WAS REPORTED AS CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED CEA RESULT.