ARCHITECT CEA

Additional Manufacturer Narrative

REVIEW OF COMPLAINT ACTIVITY DETERMINED THAT THERE WAS NORMAL COMPLAINT ACTIVITY FOR REAGENT LOT 94415FN00. REVIEW OF TRACKING AND TRENDING REPORTS DID NOT IDENTIFY ANY RELATED TRENDS FOR THE ARCHITECT CEA ASSAY. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THEREFORE, TESTING OF A SERUM BASED PANEL WAS PERFORMED USING A RETAINED KIT OF LOT 94415FN00. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. USING WORLDWIDE FIELD DATA THE HISTORICAL PERFORMANCE OF REAGENT LOT 94415FN00 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 94415FN00. MANUFACTURING DOCUMENTATION FOR THE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. ADDITIONALLY, LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CEA ASSAY WAS IDENTIFIED.

Additional Manufacturer Narrative

PATIENT INFORMATION. PATIENT IDENTIFIER: COMPLETE NUMBER (B)(6). SECTION NO FURTHER PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. 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 FALSE NEGATIVE ARCHITECT CEA RESULT FOR 1 PATIENT. THE FOLLOWING PATIENT DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = <0.5 NG/ML, REPEAT = 327.55 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.