ARCHITECT CEA

Additional Manufacturer Narrative

(B)(4). CORRECTION:THIS EVENT WAS PREVIOUSLY SUBMITTED MARCH 12, 2014 UNDER MANUFACTURING REPORT NUMBER 1415939-2014-00065 UNDER AN INCORRECT MANUFACTURING LOCATION. THE MISTAKE WAS FOUND ON APRIL 11, 2016. PRODUCT EVALUATION HAS BEEN PERFORMED IN ORDER TO INVESTIGATE THE ISSUE. THE TICKET SEARCHES DETERMINED THAT THERE IS NO UNUSUAL ACTIVITY FOR THE LIKELY CAUSE LOT FOR THE SPECIFIC ISSUE REPORTED IN THIS TICKET. TESTING OF PANELS WHICH MIMIC PATIENT SAMPLES USING IN-HOUSE RETAINED KITS STORED AT THE RECOMMENDED STORAGE CONDITION WAS PERFORMED. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER OBSERVATION. BASED ON THE INVESTIGATION RESULTS, IT WAS DETERMINED THAT ARCHITECT CEA REAGENT IS PERFORMING AS INTENDED. NO PRODUCT DEFICIENCY OR MALFUNCTION WERE IDENTIFIED AS THE SUSPECTED LOW RESULT WAS OBSERVED FOR A DISCRETE PATIENT SAMPLE AND PER REPRESENTATIVE DATA IN THE PACKAGE INSERT FOR EXPECTED VALUES, 10.7% OF COLORECTAL CANCER PATIENTS MAY HAVE LEVELS IN THE RANGE 3-5NG/ML. THE PACKAGE INSERT SECTION FOR SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS INCLUDED THE PROPER PREPARATION, PROCESSING AND HANDLING OF PATIENT SPECIMENS. IT ALSO INDICATED THAT PATIENTS WITH CONFIRMED CARCINOMA FREQUENTLY HAVE A PRETREATMENT CEA LEVEL IN THE SAME RANGE AS HEALTHY INDIVIDUALS. SERUM OR PLASMA CEA LEVEL, REGARDLESS OF VALUE, SHOULD NOT BE INTERPRETED AS ABSOLUTE EVIDENCE FOR THE PRESENCE OR ABSENCE OF MALIGNANT DISEASE. THE CEA LEVEL SHOULD BE USED IN CONJUNCTION WITH INFORMATION AVAILABLE FROM CLINICAL EVALUATION AND OTHER DIAGNOSTIC PROCEDURES. THE TROUBLESHOOTING AND DIAGNOSTICS SECTION OF THE ARCHITECT SYSTEM OPERATIONS MANUAL DOCUMENTS SOME PROBABLE CAUSES OF THE DISCREPANT RESULTS.

Description of Event or Problem

THE CUSTOMER QUESTIONED THE LOW ARCHITECT CEA RESULT (4.4 NG/ML) GENERATED ON (B)(6) FROM ONE PATIENT SAMPLE WITH A HISTORY OF UNTREATED COLON CANCER. THE CUSTOMER IS COMPARING THE RECENT LOW RESULT WITH THE PREVIOUS HIGH RESULT OF 110.2 NG/ML GENERATED FORM THIS PATIENT BACK IN (B)(6). THE PATIENT THEN WENT THROUGH A NECESSARY OPERATION ON (B)(6) FOR THE COLON CANCER AND THE RESULTS WENT DOWN TO 3.2 NG/ML. NO ADVERSE IMPACT TO PATIENT HEALTH WAS REPORTED. NOTE: THIS EVENT WAS PREVIOUSLY SUBMITTED UNDER MANUFACTURING REPORT NUMBER 1415939-2014-00065 UNDER AN INCORRECT MANUFACTURING LOCATION.