CEA

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT WITH A HISTORY OF BREAST CANCER TESTED FOR CARCINOEMBRYONIC ANTIGEN (CEA). THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT WAS TESTED FOR CEA ON AN RIA SYSTEM UNTIL (B)(6) 2015. CLARIFICATION ON THIS DATE HAS BEEN REQUESTED. AFTER THIS POINT, THEY BEGAN TO USE THE E601 ANALYZER. ON (B)(6) 2015, THE INITIAL CEA RESULT FROM THE E601 ANALYZER WAS 18.59 NG/ML. THE CLINICIAN COMPLAINED ABOUT THIS RESULT BECAUSE THE PATIENT'S CONDITION WAS NORMAL. THERE WERE NO SYMPTOMS OR IMAGES THAT WOULD INDICATE METASTASIS OR CANCER. REPEAT TESTING WAS PERFORMED ON AN ARCHITECT ANALYZER WITH 1 RESULT OF 18.46 NG/ML AND A 2ND ARCHITECT ANALYZER RESULT OF 19.87 NG/ML, A CENTAUR ANALYZER WITH A RESULT OF 2.5 NG/ML, AN IMMUNOTECH SYSTEM WITH A RESULT OF 2.06 NG/ML, AND AN RIA SYSTEM WITH A RESULT OF 2.3 NG/ML. THE CLINICIAN BELIEVES THERE MAY BE AN INTERFERENCE CONTRIBUTING TO THE DIFFERENCES IN RESULTS. ON (B)(6) 2015, THE PATIENT HAD A CHEST CT SCAN, A BREAST ULTRASOUND, AND AN RMD MAMMOGRAPHY, ALL OF WHICH SHOWED NO EVIDENCE OF NEWLY DEVELOPED CANCER. NO ADVERSE EVENT OCCURRED. THE PATIENT IS IN GOOD CONDITION. THE E601 ANALYZER SERIAL NUMBER WAS NOT PROVIDED.

Additional Manufacturer Narrative

A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. PATIENT RESULTS CAN VARY DEPENDING ON THE TESTING PROCEDURE USED. CEA VALUES DETERMINED ON PATIENT SAMPLES BY DIFFERENT TESTING PROCEDURES CANNOT BE DIRECTLY COMPARED WITH ONE ANOTHER AND COULD BE THE CAUSE OF ERRONEOUS MEDICAL INTERPRETATIONS. THIS ISSUE IS COVERED IN PRODUCT LABELING.