ACCESS CEA REAGENT

Additional Manufacturer Narrative

(B)(6). THE ACCESS CEA REAGENT WAS NOT RETURNED FOR EVALUATION. NO HARDWARE ERRORS, FLAGS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. THE CUSTOMER SENT THE PATIENT'S SAMPLE TO THE (B)(6) FOR ADDITIONAL TESTING. THE CHU LABORATORY PERFORMED INTERFERENCE TESTING USING A VARIETY OF BLOCKING AGENTS INCLUDING AN ALKALINE PHOSPHATASE BLOCKER. AFTER THE ADDITION OF THE ALKALINE PHOSPHATASE BLOCKER THE SAMPLE'S DOSE WAS REDUCED SIGNIFICANTLY. THEREFORE, A PATIENT-SOURCE INTERFERENT WAS CONFIRMED. IN CONCLUSION, A PATIENT-SOURCE INTERFERENT IS THE CAUSE OF THE REPRODUCIBLE ELEVATED ACCESS CEA RESULTS OBTAINED BY THE CUSTOMER.

Description of Event or Problem

THE CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT OBTAINING REPRODUCIBLE ELEVATED CARCINOEMBRYONIC ANITGEN (ACCESS CEA) RESULTS FOR ONE (1) PATIENT ON THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, SERIAL NUMBER (B)(4). IN (B)(6) 2018 (EXACT DATE IS UNKNOWN) THE PATIENT HAD AN EXTREMELY ELEVATED ACCESS CEA RESULT, POST LUNG SURGERY (SURGERY OCCURRED IN (B)(6) 2017). THEN AGAIN IN (B)(6) 2018 (EXACT DATE IS UNKNOWN) THE SAME PATIENT HAD ANOTHER SIGNIFICANTLY ELEVATED ACCESS CEA RESULT. THE CUSTOMER NOTED THAT THE PATIENT'S OTHER TUMOR MARKERS (EXACT TESTS WERE NOT SUPPLIED) WERE ALL WITHIN THE APPROPRIATE CLINICAL RANGES. IN (B)(6) 2018 THE PATIENT UNDERWENT A PET CT (POSITRON EMISSION TOMOGRAPHY/COMPUTED TOMOGRAPHY) SCAN WITH CONTRAST DYE WHICH WAS DISCORDANT TO THE ACCESS CEA RESULTS OBTAINED TO DATE. ADDITIONAL ELEVATED ACCESS CEA RESULTS WERE ALSO OBTAINED IN (B)(6) 2018, (B)(6) 2019 AND (B)(6) 2019. AFTER OBTAINING ALL OF THE REPRODUCIBLE ELEVATED ACCESS CEA RESULTS THE PATIENT WENT TO TWO (2) OTHER HOSPITALS ((B)(6)) WHICH TESTED FOR CEA ON DIFFERENT METHODOLOGIES (EXACT METHODS ARE UNKNOWN). THOSE RESULTS CAME BACK WITHIN THE ASSAYS' NORMAL REFERENCE RANGES WHICH WAS EXPECTED FOR THE PATIENT. AS STATED PREVIOUSLY, THERE WAS A CHANGE TO THE PATIENT'S TREATMENT/MANAGEMENT AS THEY HAD UNDERGONE A PET CT SCAN WITH CONTRAST DYE. THE DYE USED WAS RADIOTRACER 18F-FDG. THERE WAS NO REPORT OF DEATH ASSOCIATED WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS CALIBRATIONS AND SYSTEM CHECKS WERE PASSING WITHIN SYSTEM AND ASSAY SPECIFICATIONS AT THE TIME OF THE EVENT. THERE WERE NO REPORTS OF HARDWARE ERRORS, ISSUES WITH OTHER ASSAYS OR OTHER PATIENT RESULTS IN CONJUNCTION WITH THIS EVENT. THE CUSTOMER DID NOT SUPPLY SAMPLE COLLECTION OR PROCESSING INFORMATION SUCH AS TUBE TYPE, CENTRIFUGATION SPEED OR CENTRIFUGATION TIME. THERE WERE NO REPORTS OF SAMPLE ISSUES INCLUDING PRE-ANALYTICAL SAMPLE HANDLING PROBLEMS. THE CUSTOMER SENT THE PATIENT'S SAMPLE TO THE COMPLAINT HANDLING UNIT (CHU) IN (B)(6) FOR ADDITIONAL TESTING.