CEA ELECSYS

Additional Manufacturer Narrative

(B)(6).

Description of Event or Problem

THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT TESTED FOR CARCINOEMBRYONIC ANTIGEN (CEA). THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2016 THE PATIENT WAS TESTED ON AN ARCHITECT SYSTEM IN LABORATORY 1 AND THE RESULT WAS 30.5 NG/ML. THE PATIENT WAS CONFUSED BY THE HIGH RESULT. ON (B)(6) 2016 A NEW SAMPLE WAS OBTAINED AND THE RESULT FROM A SIEMENS CENTAUR SYSTEM FROM LABORATORY 2 WAS 2.4 NG/ML. ON (B)(6) 2016 A NEW SAMPLE WAS OBTAINED AND THE RESULT FROM AN UNKNOWN SYSTEM FROM LABORATORY 3 WAS 29.4 NG/ML. ON (B)(6) 2016 A NEW SAMPLE WAS OBTAINED AND DIVIDED INTO PARTS AND SENT TO 3 OTHER LABORATORIES. THE CEA RESULT FROM LABORATORY 4 USING A SIEMENS CENTAUR SYSTEM WAS 2.5 NG/ML. THE CEA RESULT FROM LABORATORY 5 USING AN E601 ANALYZER WAS 39.7 NG/ML. ON (B)(6) 2016 THE SAMPLE WAS REPEATED ON AN E602 ANALYZER FROM LABORATORY 6 AND THE CEA RESULT WAS 39.91 NG/ML. NO ADVERSE EVENT OCCURRED. THE E602 ANALYZER SERIAL NUMBER WAS (B)(4). THE E601 ANALYZER SERIAL NUMBER WAS NOT PROVIDED.

Additional Manufacturer Narrative

THE PATIENT SAMPLE DATED (B)(6) 2016 WAS SUBMITTED FOR INVESTIGATION. DURING THE INVESTIGATION, THE CEA RESULT FROM THE E602 ANALYZER WAS CONFIRMED. AN INTERFERING FACTOR WAS NOT IDENTIFIED IN THE SAMPLE. DILUTION TESTING WAS PERFORMED AND ALL RESULTS WERE WITHIN THE SPECIFIED RANGES. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. DIFFERENCES IN REACTION PROFILES FROM THE AVAILABLE CEA TESTS BASED ON THE HETEROGENIC NATURE OF THE ANTIGEN SHOULD BE TAKEN INTO ACCOUNT WHEN COMPARING RESULTS FROM DIFFERENT MANUFACTURERS.