CARCINOEMBRYONIC ANTIGEN - CEA

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT SAMPLE TESTED FOR CARCINOEMBRYONIC ANTIGEN (CEA). THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL CEA RESULT FROM THE E601 ANALYZER WAS 15.9 UG/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2015, THE PATIENT WENT TO ANOTHER LABORATORY WHERE THE CEA RESULT FROM A SIEMENS ANALYZER WAS 1.6 UG/L. ON (B)(6) 2015, THE ORIGINAL SAMPLE FROM (B)(6) 2015 WAS REPEATED TWICE ON THE E601 ANALYZER WITH RESULTS OF 16.15 UG/L AND 16.27 UG/L. AN ALIQUOT OF THIS SAMPLE WAS SENT TO THE EXTERNAL LABORATORY WITH THE SIEMENS ANALYZER AND THE RESULT WAS 2.0 UG/L. NO ADVERSE EVENT DUE TO THE DEVICE WAS REPORTED. THE E601 ANALYZER SERIAL NUMBER WAS (B)(4). QUALITY CONTROLS WERE ACCEPTABLE. ANALYZER MAINTENANCE HAS BEEN PERFORMED ON SCHEDULE.

Additional Manufacturer Narrative

IT WAS NOTED THAT THE PATIENT HAD A PET SCAN ON (B)(6) 2015 BASED ON THE HIGH CEA RESULT FROM THE ROCHE DEVICE. NO FURTHER DETAILS WERE PROVIDED. A SAMPLE WAS SUBMITTED FOR INVESTIGATION. THE INVESTIGATION WAS ABLE TO REPRODUCE THE CUSTOMER'S CEA RESULTS. A REAGENT SPECIFIC ISSUE WAS NOT IDENTIFIED.

Additional Manufacturer Narrative

THE SAMPLE WAS TESTED FOR AN INTERFERENCE. NO INTERFERENCE WAS IDENTIFIED IN THE PATIENT SAMPLE. THE ANTIBODIES USED IN THE ROCHE CEA ASSAY ARE DESIGNED TO RECOGNIZE THE NON-SPECIFIC CROSS-ACTING ANTIGEN (NCA-2) WHICH WAS FOUND TO BE A BENEFIT IN EARLY DETECTION OF COLORECTAL CANCER METASTATIS AND RELAPSE. THE SIEMENS CENTAUR ASSAY USES ANTIGENS WITH A DIFFERENT RECOGNITION. DIFFERENCES IN CEA RESULTS MAY OCCUR WHEN THE SAMPLE IS MEASURED WITH DIFFERENT ASSAYS. THIS IS ADDRESSED IN PRODUCT LABELING.