ARCHITECT CA19-9XR

Additional Manufacturer Narrative

COMPLETED INFORMATION FOR SECTION A1 PATIENT INFORMATION: SID (B)(6), 57-YEAR-OLD FEMALE. SID (B)(6), 50-YEAR-OLD FEMALE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 02K91-39 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 02K91-33, WITH 510K/PMA/BLA NUMBER K052000.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT CA19-9XR RESULTS FOR MULTIPLE PATIENTS. THE FOLLOWING DATA WAS PROVIDED: 57-YEAR-OLD FEMALE PATIENT (DIAGNOSED WITH PANCREATIC CANCER): (B)(6) 2025, SID (B)(6): INITIAL RESULT = 42.12 U/ML, REPEATS WERE <2.00 U/ML AND <2.00 U/ML HISTORICAL RESULTS FROM (B)(6) 2025 UNTIL (B)(6) 2025 WERE <2.00 U/ML 50-YEAR-OLD FEMALE PATIENT (UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER): (B)(6) 2025, SID (B)(6): INITIAL RESULT WAS <2.00 U/ML, REPEATS = 10.05 U/ML AND <2.00 U/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT CA19-9XR RESULTS FOR MULTIPLE PATIENTS. THE FOLLOWING DATA WAS PROVIDED: 57 YEAR OLD FEMALE PATIENT (DIAGNOSED WITH PANCREATIC CANCER): (B)(6) 2025, SID (B)(6): INITIAL RESULT = 42.12 U/ML, REPEATS WERE <2.00 U/ML AND <2.00 U/ML. HISTORICAL RESULTS FROM (B)(6) 2025 UNTIL (B)(6) 2025 WERE <2.00 U/ML. 50 YEAR OLD FEMALE PATIENT (UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER): (B)(6) 2025, SID (B)(6): INITIAL RESULT WAS <2.00 U/ML, REPEATS = 10.05 U/ML AND <2.00 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ARCHITECT CA 19-9XR REAGENT LOT 78761FP00. REVIEW OF TRACKING AND TRENDING BY LIST NUMBER AND BY COMPLAINT LOT DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. HISTORICAL PERFORMANCE OF REAGENT LOT 78761FP00 EVALUATED USING WORLDWIDE FIELD DATA FOR THE ARCHITECT CA 19-9XR ASSAY. THE PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THE PATIENT MEDIANS WERE WITHIN THE ESTABLISHED LIMITS, INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY IN THE FIELD. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ARCHITECT CA 19-9XR REAGENT LOT 78761FP00.