ARCHITECT CA19-9XR REAGENT KIT

Additional Manufacturer Narrative

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 2K91-39 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2K91-33

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT CA 19-9XR GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE AN 85-YEAR-OLD MALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2024, SID (B)(6) , INITIAL RESULT 960 U/ML, REPEAT RESULT 1934 U/ML, RESULT (B)(6) 2023 = 23.3 U/ML. ON (B)(6) 2024, ADDITIONAL RESULTS FOR SID 5036: > 1200.00 U/ML, 1:2 DILUTION RESULT = 776.98 U/ML, 1:4 DILUTION RESULT = 346.34 U/ML, 1:8 DILUTION RESULT = 137.15 U/ML, 1:16 DILUTION RESULT = 69.51 U/ML ADDITIONAL LAB RESULTS PROVIDED: ON (B)(6) 2023 CEA RESULT = 4.5 NG/ML, (B)(6) 2024 RESULT = 3.3 NG/ML, AFP RESULT = <2. THE CUSTOMER IS NOT QUESTIONING THE CEA AND AFP RESULTS AS INCORRECT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ARCHITECT CA 19-9XR RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WAS REVIEWED. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. CUSTOMER FIELD DATA WAS USED TO ASSESS THE PERFORMANCE OF THE ARCHITECT CA 19-9XR ASSAY USING WORLDWIDE DATA. REVIEW SHOWS THAT THE MEDIAN PATIENT RESULT FOR LOT 64207FP00 IS WITHIN ESTABLISHED LIMITS AND COMPARABLE WITH OTHER LOTS IN THE FIELD, CONFIRMING NO SYSTEMIC ISSUE FOR LOT 64207FP00. THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON LOT 64207FP00 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CA 19-9XR ASSAY FOR LOT NUMBER 64207FP00 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT CA 19-9XR GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE AN 85-YEAR-OLD MALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6)2024, SID (B)(6), INITIAL RESULT 960 U/ML, REPEAT RESULT 1934 U/ML, RESULT (B)(6)2023 = 23.3 U/ML. ON (B)(6) 2024 ADDITIONAL RESULTS FOR SID (B)(6): > 1200.00 U/ML, 1:2 DILUTION RESULT = 776.98 U/ML, 1:4 DILUTION RESULT = 346.34 U/ML, 1:8 DILUTION RESULT = 137.15 U/ML, 1:16 DILUTION RESULT = 69.51 U/ML ADDITIONAL LAB RESULTS PROVIDED: ON (B)(6) 2023 CEA RESULT = 4.5 NG/ML, ON (B)(6)2024 RESULT = 3.3 NG/ML, AFP RESULT = <2. THE CUSTOMER IS NOT QUESTIONING THE CEA AND AFP RESULTS AS INCORRECT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.