CARCINOEMBRYONIC ANTIGEN - CEA

Additional Manufacturer Narrative

THE PATIENT SAMPLE TESTED FOR CEA FROM (B)(6) 2015 WAS SUBMITTED FOR INVESTIGATION. THE SAMPLE WAS MEASURED AND A VALUE OF >100,000 NG/ML WAS OBTAINED AFTER DILUTION. THE INITIAL RESULT OF 632.9 NG/ML AT THE INVESTIGATION SITE WAS DUE TO A HIGH DOSE HOOK EFFECT. THE INCREASED VALUES FOR CEA WERE VERIFIED IN THE DILUTED SAMPLE. THE CUSTOMER'S CEA RESULTS WERE REPRODUCIBLE. THE CEA ASSAY MEETS PRODUCT SPECIFICATION.

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE PHYSICIAN IS QUESTIONING THE RESULTS FROM 1 PATIENT SAMPLE TESTED FOR CARBOHYDRATE ANTIGEN 19-9 (CA 19-9) AND CARCINOEMBRYONIC ANTIGEN (CEA). THE PHYSICIAN INDICATES THE CA 19-9 AND CEA RESULTS ARE ELEVATED COMPARED TO THE CLINICAL STATUS OF THE PATIENT. BASED ON THE DATA PROVIDED, ERRONEOUS RESULTS WERE GENERATED FOR BOTH CA 19-9 AND CEA. COMPARISON TESTING WAS PERFORMED BETWEEN THE CUSTOMER'S E601 ANALYZER, AN E MODULE ANALYZER AT ANOTHER HOSPITAL AND A LUMIPULSE METHOD. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER SUBMITTED THE PATIENT SAMPLE FOR INVESTIGATION. BASED ON THE DATA PROVIDED ERRONEOUS CA 19-9 RESULTS WERE IDENTIFIED BETWEEN THE E411 ANALYZER USED AT THE INVESTIGATION SITE AND BOTH THE LUMIPULSE RESULTS THAT THE CUSTOMER ORGANIZED AND THE ARCHITECT RESULTS THAT THE INVESTIGATION UNIT ORGANIZED. ERRONEOUS CEA RESULTS WERE IDENTIFIED BETWEEN THE E411 ANALYZER USED AT THE INVESTIGATION SITE AND THE LUMIPULSE RESULTS ORGANIZED BY THE CUSTOMER. THIS MEDWATCH WILL COVER CEA. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CA 19-9 ERRONEOUS RESULTS. NO ADVERSE EVENT WAS REPORTED. THE CUSTOMER'S E601 ANALYZER SERIAL NUMBER WAS NOT PROVIDED. THE E411 SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(4). THE CEA REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE WAS 180801. THE EXPIRATION DATE WAS NOT PROVIDED.

Additional Manufacturer Narrative

THE CUSTOMER PROVIDED AN ADDITIONAL PATIENT SAMPLE DRAWN ON (B)(6) 2015 FOR INVESTIGATION THAT WAS TESTED FOR CEA. SEE THE ATTACHMENT TO THE MEDWATCH FOR THE PATIENT RESULTS AND OTHER RELEVANT CEA RESULTS.(B)(4). THE CEA REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE WAS 185168. THE EXPIRATION DATE WAS NOT PROVIDED.