ARCHITECT CEA

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4). NO ADVERSE IMPACT WAS REPORTED DUE TO THE PROCEDURES.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE ELEVATED ARCHITECT CEA RESULT. THE SAMPLE GENERATED A RESULT OF 50.3 NG/ML. THE PATIENT'S PREVIOUS RESULT WAS 28.1 NG/ML. THE CUSTOMER INDICATED THE PATIENT HAD A PET-CT, COLON FIBERSCOPE AND GASTROSCOPY DUE TO THE ELEVATED CEA RESULTS. THERE WAS NO ADVERSE IMPACT TO THE PATIENT DUE TO THE PROCEDURES.

Additional Manufacturer Narrative

REVIEW OF COMPLAINT ACTIVITY DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR LIKELY CAUSE LOT 90351FN00. TRACKING AND TRENDING REPORT REVIEW FOR THE ARCHITECT CEA ASSAY DETERMINED THAT THERE ARE NO RELATED ADVERSE OR NON-STATISTICAL TRENDS. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. USING WORLDWIDE FIELD DATA THE HISTORICAL PERFORMANCE OF REAGENT LOT 90351FN00 WAS EVALUATED. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR THE LOT WAS COMPARABLE WITH ALL OTHER LOTS IN THE FIELD. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED FOR LOT 90351FN00. TESTING OF A SERUM BASED PANEL SAMPLE WITH A KNOWN CONCENTRATION, WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF LOT 90351FN00. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND INDICATES THE ARCHITECT CEA ASSAY SHOULD NOT BE USED AS A CANCER SCREENING TEST. THE ARCHITECT CEA ASSAY IS TO BE USED AS AN AID IN THE PROGNOSIS AND MANAGEMENT OF CANCER PATIENTS IN WHOM CHANGING CONCENTRATIONS OF CEA ARE OBSERVED. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CEA ASSAY WAS IDENTIFIED.