ARCHITECT CEA

Additional Manufacturer Narrative

A REVIEW OF TICKETS FOUND NO OTHER COMPLAINTS FOR LOT 09599FN00, AND NO TRENDS WERE IDENTIFIED FOR THE ISSUE FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. CUSTOMER FIELD DATA WAS USED TO ASSESS THE PERFORMANCE OF THE ARCHITECT CEA ASSAY USING WORLD WIDE DATA THROUGH ABBOTTLINK. THE MEDIAN POPULATION RESULT FOR LOT 09599FN00 IS COMPARABLE WITH ALL OTHER LOTS IN THE FIELD AND FALLS WITHIN ESTABLISHED BASELINES, CONFIRMING NO SYSTEMIC ISSUE FOR THE LOT. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. A RESULT LOG FROM THE CUSTOMER'S INSTRUMENT, SERIAL NUMBER (B)(4), WAS REVIEWED FOR CEA PATIENT TEST DATA, SHOWING A RESULT OF 19.9NG/ML WAS OBTAINED FOR (B)(4)ON (B)(6) 2020. HOWEVER, A RESULT OF 9NG/ML COULD NOT BE FOUND FOR THIS SID. THE REVIEW DID IDENTIFY THE SID HAD BEEN TESTED ON (B)(6) 2020, WITH A RESULT OF 19.4 NG/ML, WHICH IS CONSISTENT WITH THE RESULT OF 19.9NG/ML GENERATED ON (B)(6) 2020. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT CEA REAGENT, LOT 09599FN00.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE IS NO FURTHER PATIENT INFORMATION PROVIDED DUE TO PRIVACY ISSUES.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY DEPRESSED ARCHITECT CEA RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: (B)(6) DAY 1 ARCHITECT=9NG/ML/ ROCHE = 23NG/ML; DAY 2 ARCH = 19.9NG/ML / ROCHE = 23NG/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.