ARCHITECT CEA

Additional Manufacturer Narrative

PATIENT INFORMATION: NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBTAINED A FALSELY DEPRESSED ARCHITECT CEA RESULT. SAMPLE 1 GENERATED A RESULT OF 4.69 NG/ML ON THE CURRENT LOT AND WHEN RETESTED ON A NEW LOG GENERATED 6.37 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR POTENTIAL FALSE DEPRESSED CEA RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELLING, DEVICE HISTORY RECORDS AND FIELD DATA REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. PERFORMANCE OF REAGENT LOT 04200FN00 WAS EVALUATED USING WORLD WIDE FIELD DATA. THE PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR LOT 04200FN00 IS WITHIN THE ESTABLISHED LIMITS, THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED. TRENDING DATA FOR THE ARCHITECT CEA ASSAY WAS REVIEWED AND IDENTIFIED NO TRENDS ASSOCIATED WITH THE ISSUE. DEVICE HISTORY RECORD REVIEW FOR LOT 04200FN00 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. ADDITIONALLY, THE CUSTOMER ISSUE WAS RESOLVED WHEN LOT 04200FN00 WAS RECALIBRATED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CEA ASSAY, LOT NUMBER 04200FN00 WAS IDENTIFIED.