CARCINOEMBRYONIC ANTIGEN (CEA)

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR CARCINOEMBRYONIC ANTIGEN (CEA) ON A COBAS 8000 ANALYZER. THE SAMPLE INITIALLY RESULTED AS 5.66 NG/ML ON THE COBAS 8000 ANALYZER AND THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS SENT TO ANOTHER LABORATORY WHERE IT WAS TESTED USING WHAT WAS ASSUMED TO BE SIEMENS AND FUJIREBIO REAGENTS. THE CEA RESULT WAS 1.2 NG/ML WHEN TESTED WITH THE SIEMENS REAGENT AND THE CEA RESULT WAS 1.9 NG/ML WHEN TESTED WITH THE FUJIREBIO REAGENT. IT WAS ASKED, BUT IT IS NOT KNOWN IF THE PATIENT WAS ADVERSELY AFFECTED. NO ADVERSE EVENTS WERE ALLEGED. THE COBAS 8000 ANALYZER SERIAL NUMBER WAS ASKED FOR, BUT NOT PROVIDED.

Additional Manufacturer Narrative

A SPECIFIC ROOT CAUSE FOR THE DIFFERENCE IN THE COBAS 8000 RESULTS COMPARED TO THE SIEMENS AND/OR FUJIREBIO ASSAYS COULD NOT BE DETERMINED. THE COBAS 8000 RESULT WAS VERIFIED BY THE ABBOTT ARCHITECT RESULT. THE RESULTS OF THE SIEMENS AND FUJIREBIO ASSAYS WERE NOT REPRODUCIBLE. PRODUCT LABELING STATES THE MEASURED CEA VALUE OF A PATIENT'S SAMPLE CAN VARY DEPENDING ON THE TESTING PROCEDURE USED. CEA VALUES DETERMINED ON PATIENT SAMPLES BY DIFFERENT TESTING METHODS CANNOT BE DIRECTLY COMPARED WITH ONE ANOTHER.

Additional Manufacturer Narrative

THE QUESTIONED SAMPLE WAS PROVIDED FOR INVESTIGATION. DURING INVESTIGATIONS, THE SAMPLE WAS MEASURED ON AN E411 ANALYZER AND RESULTED AS 6.5 NG/ML. THE SAMPLE WAS ALSO MEASURED ON AN ARCHITECT ANALYZER, RESULTING AS 5.9 NG/ML. BOTH METHODS GENERATED RESULTS WHICH ARE ABOVE THE NORMAL REFERENCE RANGE OF THE RESPECTIVE ASSAYS. NO SIGNIFICANT DISCREPANCY WAS FOUND BETWEEN THE E411 ANALYZER AND THE ARCHITECT ANALYZER. REAGENT LOT NUMBER 187686 WAS USED ON THE E411 ANALYZER USED FOR INVESTIGATIONS.