ARCHITECT CEA

Additional Manufacturer Narrative

(B)(4). AN EVALUATION WAS PERFORMED BY REVIEWING THE COMPLAINT TEXT, OTHER CUSTOMER COMPLAINTS FOR SIMILAR ISSUES, A REVIEW OF LABELING, AND A REVIEW OF HISTORICAL DATA. THE CUSTOMER REPORTED FALSE ELEVATED PATIENT RESULTS WHEN TESTING WITH THE ARCHITECT CEA ASSAY, LIST 7K68-27, UNKNOWN LOT. THE COMPLAINT TEXT CONFIRMS THAT THE CUSTOMER WAS USING THE ASSAY TO TEST NON-CANCER PATIENTS WHICH IS OUTSIDE THE INTENDED USE OF THE ASSAY AS DESCRIBED IN THE REAGENT PACKAGE INSERT. A REVIEW OF THE ARCHITECT CEA PACKAGE INSERT CLEARLY INDICATES THAT THE INTENDED USE OF THE PRODUCT IS AS AN AID IN THE PROGNOSIS AND MANAGEMENT OF CANCER PATIENTS IN WHOM CHANGING CONCENTRATIONS OF CEA ARE OBSERVED. CEA TESTING IS NOT RECOMMENDED AS A SCREENING PROCEDURE TO DETECT CANCER IN THE GENERAL POPULATION. A REVIEW OF COMPLAINTS DETERMINED THAT THERE IS NO TREND FOR THE COMPLAINT ISSUE FOR THIS PRODUCT. ADDITIONAL INVESTIGATION TASKS CANNOT BE PERFORMED AS THE LIKELY CAUSE LOT IS UNKNOWN. IN ADDITION, THE ISSUE IS NOT RELATED TO THE PERFORMANCE OR MANUFACTURE OF THE PRODUCT, BUT TO THE PRODUCT BEING USED BY THE CUSTOMER OUTSIDE ITS INTENDED USE. THERE IS NO MALFUNCTION IDENTIFIED AS THE CUSTOMER WAS USING THE ASSAY OUTSIDE OF ITS INTENDED PURPOSE AS INDICATED IN THE PRODUCT PACKAGE INSERT.

Description of Event or Problem

THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED A FALSELY ELEVATED CEA RESULT ON A PATIENT. THE CEA RESULT FOR (B)(6) WAS 10.3. DUE TO THE CEA RESULT THE PATIENT HAD AN UNNECESSARY ENDOSCOPY PERFORMED WHICH WAS TOLERATED WELL WITH NO NEGATIVE OUTCOME.

Additional Manufacturer Narrative

THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED, THEREFORE, THE DEVICE WAS NOT PERFORMING AS INTENDED. (B)(4).