ARCHITECT CEA

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY DECREASED CEA RESULT WHILE USING THE ARCHITECT CEA ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING DATA FOR ONE PATIENT: INITIAL: 0.58, RETEST 840. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE.

Additional Manufacturer Narrative

EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, FIELD DATA REVIEW, A BATCH RECORD REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. RETURN MATERIAL WAS NOT AVAILABLE. AN ANALYSIS UTILIZING CUSTOMER FIELD DATA WAS USED TO ASSESS THE SPECIFICITY OF THE ASSAY. INSTRUMENT DATA ANALYTICS (IDA) REPORTS FOR THE ARCHITECT CEA ASSAY WERE REVIEWED TO DETERMINE IF THE MEDIAN PATIENT VALUES HAVE SHIFTED OVER TIME. THE ANALYSIS CONCLUDED THAT ALL REAGENT LOTS READ PATIENT RESULTS CONSISTENTLY THEREFORE DETERMINED THE REAGENT IS PERFORMING ACCEPTABLY. THE BATCH RECORD REVIEW DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES, NON-CONFORMANCES OR DEVIATIONS RELATED TO THE COMPLAINT ISSUE. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF THE ARCHITECT CEA REAGENT, LIST NUMBER 07K68, WAS IDENTIFIED.