ARCHITECT CA19-9XR

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT CA 19 9XR RESULTS GENERATED BY THE ARCHITECT I2000SR FOR A 71-YEAR-OLD MALE PATIENT WHO WAS DIAGNOSED WITH PANCREATIC CANCER IN 2024. THE PATIENT UNDERWENT SURGERY IN (B)(6) 2024 AND HAS SINCE BEEN RECEIVING ONGOING CHEMOTHERAPY AND/OR RADIOTHERAPY WITH REGULAR CA 19 9 MONITORING. THE PATIENT ALTERNATED FOLLOW UP VISITS BETWEEN TWO HOSPITAL CAMPUSES, RESULTING IN CA 19 9 MEASUREMENTS BEING PERFORMED ON DIFFERENT ANALYTICAL SYSTEMS (ARCHITECT AND ROCHE PLATFORMS). THE CUSTOMER IS QUESTIONING THE ARCHITECT CA 19-9XR RESULTS FROM MARCH. THE FOLLOWING DATA WERE PROVIDED: SID (B)(6): (B)(60 2026: ARCHITECT CA 19 9XR RESULT = 229.4 U/ML (REFERENCE RANGE: 0 TO 37 U/ML) (B)(6) 2026: ROCHE PLATFORM RESULT = 104 U/ML (REFERENCE RANGE: 0 TO 30 U/ML) (B)(6) 2026: ARCHITECT CA 19 9XR RESULT = 529.31 U/ML; REPEAT RESULT = 490.97 U/ML (B)(6) 2026: ROCHE PLATFORM RESULT = 110 U/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Additional Manufacturer Narrative

THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 77710FP01. A REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT CA 19-9XR ASSAY DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NONCONFORMANCE, POTENTIAL NONCONFORMANCE, OR DEVIATIONS WITH LOT 77710FP01 AND THE COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF THE ARCHITECT CA 19-9XR REAGENTS WAS REVIEWED USING FIELD DATA FROM CUSTOMERS WORLDWIDE. THE PATIENT¿S DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR THE COMPLAINT LOT IS WITHIN THE ESTABLISHED CONTROL LIMITS. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED FOR LOT 77710FP01. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. IN THIS CASE, THE PATIENT RESULTS OBTAINED ON THE ARCHITECT WERE BEING COMPARED AGAINST PATIENT RESULTS FROM ANOTHER METHOD, AND PER THE PACKAGE INSERT, THIS IS NOT ALLOWED. BASED ON THE INVESTIGATION, ARCHITECT CA 19-9XR, LOT 77710FP01 IS PERFORMING AS INTENDED. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CA 19-9XR REAGENT WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT CA 19 9XR RESULTS GENERATED BY THE ARCHITECT I2000SR FOR A 71-YEAR-OLD MALE PATIENT WHO WAS DIAGNOSED WITH PANCREATIC CANCER IN 2024. THE PATIENT UNDERWENT SURGERY IN (B)(6) 2024 AND HAS SINCE BEEN RECEIVING ONGOING CHEMOTHERAPY AND/OR RADIOTHERAPY WITH REGULAR CA 19 9 MONITORING. THE PATIENT ALTERNATED FOLLOW UP VISITS BETWEEN TWO HOSPITAL CAMPUSES, RESULTING IN CA 19 9 MEASUREMENTS BEING PERFORMED ON DIFFERENT ANALYTICAL SYSTEMS (ARCHITECT AND ROCHE PLATFORMS). THE CUSTOMER IS QUESTIONING THE ARCHITECT CA 19-9XR RESULTS FROM MARCH. THE FOLLOWING DATA WERE PROVIDED: SID (B)(6): (B)(6) 2026: ARCHITECT CA 19 9XR RESULT = 229.4 U/ML (REFERENCE RANGE: 0 TO 37 U/ML), (B)(6) 2026: ROCHE PLATFORM RESULT = 104 U/ML (REFERENCE RANGE: 0 TO 30 U/ML), (B)(6) 2026: ARCHITECT CA 19 9XR RESULT = 529.31 U/ML; REPEAT RESULT = 490.97 U/ML, (B)(6) 2026: ROCHE PLATFORM RESULT = 110 U/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.