ARCHITECT CEA REAGENT KIT

Additional Manufacturer Narrative

SID IS (B)(6); NO PATIENT DEMOGRAPHIC 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 IDENTIFIED FALSELY DEPRESSED ARCHITECT CEA (CARCINOEMBRYONIC ANTIGEN) RESULTS FOR ONE PATIENT. THE CUSTOMER PROVIDED THE FOLLOWING INFORMATION: CEA (B)(6) 2022 SID: (B)(6) GENERATED WITH SERIAL NUMBER (B)(4) RESULT 80.25 NG/ML WITH REAGENT LOT 29180FN00; GENERATED WITH SERIAL NUMBER (B)(4) RESULT < 0.50 NG / ML WITH REAGENT LOT 29180FN00, RETEST 1:1 79.80 NG/ML AND 84.3 NG/ML. THE CUSTOMER REPORTED RESULTS AS 80.25 NG/ML. PATIENT HISTORY: (B)(6) 2022 12.3 NG/L. THE PATIENT IS A (B)(6) FEMALE WITH A MALIGNANT TUMOR; THE CUSTOMER IS NOT AWARE OF WHAT KIND OF CANCER THE PATIENT HAS BEEN DIAGNOSED WITH. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT EVALUATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, FIELD DATA OF ARCHITECT CEA REAGENT LOT 29180FN00. THE TICKET SEARCH DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR THE LIKELY CAUSE LOT. A REVIEW OF COMPLAINTS DETERMINED THAT THERE ARE NO TRENDS FOR THE PRODUCT FOR THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. HISTORICAL PERFORMANCE OF REAGENT LOT 29180FN00 WAS EVALUATED USING WORLDWIDE DATA FROM ABBOTTLINK. THE MEDIAN VALUE OF THE NEGATIVE PATIENT POPULATION FOR THE COMPLAINT LOT IS WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO HISTORICAL REAGENT LOT PERFORMANCE. ALL FIELD DATA DEMONSTRATING THAT THE LOT IS PERFORMING AS EXPECTED. PER THE LIMITATIONS OF THE PROCEDURE SECTION OF THE PRODUCT PACKAGE INSERT, A SERUM OR PLASMA CEA LEVEL, REGARDLESS OF VALUE, SHOULD NOT BE INTERPRETED AS ABSOLUTE EVIDENCE FOR THE PRESENCE OR ABSENCE OF MALIGNANT DISEASE. THE CEA LEVEL SHOULD BE USED IN CONJUNCTION WITH INFORMATION AVAILABLE FROM CLINICAL EVALUATION AND OTHER DIAGNOSTIC PROCEDURES. 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. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT CEA REAGENT LOT 29180FN00.