ARCHITECT CA19-9XR

Additional Manufacturer Narrative

CORRECTION TO SECTION B3 - DATE OF EVENT. THIS WAS CORRECTED FROM 05JUL2025 TO 07JUL2025. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 02K91-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 02K91-33, WITH 510K/PMA/BLA NUMBER K052000. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT CA 19-9XR FOR A FEMALE PATIENT UNDERGOING CHEMOTHERAPY. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6), INITIAL CA 19-9 RESULT= 113.98 U/ML; REPEAT RESULTS= 149.32 U/ML, 144.61 U/ML. SAMPLE WAS TESTING ON THE ALINITY SYSTEM FOR TROUBLESHOOTING PURPOSES ONLY, RESULTS= 133 U/ML. REPEAT RESULT (ROCHE ANALYZER) = 34.7 U/ML AND 32.8 U/ML (NORMAL RANGE). REPEAT RESULT (SIEMENS ANALYZER) = 42.7 U/ML (GRAY ZONE). HISTORICAL RESULTS WITH ARCHITECT ANALYZER: (B)(6) 2025, RESULT= 126.20 U/ML, (B)(6) 2025, RESULT= 129.93 U/ML, (B)(6) 2025, RESULT= 121.91 U/ML, (B)(6) 2025, RESULT= 126.94 U/ML, (B)(6) 2025, RESULT= 101.97 U/ML, (B)(6) 2025, RESULT= 100.72 U/ML, (B)(6) 2025, RESULT= 128.33 U/ML; REPEAT RESULT= 130.32 U/ML, THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT CA 19-9XR ASSAY DID NOT IDENTIFY ANY RELATED TRENDS. ADDITIONALLY, A TICKET SEARCH BY LOT DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT 74577FP00 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 LOT 74577FP00 IS WITHIN THE ESTABLISHED CONTROL LIMITS. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED FOR 74577FP00. 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 74577FP00 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 OBSERVED FALSELY ELEVATED ARCHITECT CA 19-9XR FOR A FEMALE PATIENT UNDERGOING CHEMOTHERAPY. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6), INITIAL CA 19-9 RESULT= 113.98 U/ML; REPEAT RESULTS= 149.32 U/ML, 144.61 U/ML SAMPLE WAS TESTING ON THE ALINITY SYSTEM FOR TROUBLESHOOTING PURPOSES ONLY, RESULTS= 133 U/ML REPEAT RESULT (ROCHE ANALYZER) = 34.7 U/ML AND 32.8 U/ML (NORMAL RANGE) REPEAT RESULT (SIEMENS ANALYZER) = 42.7 U/ML (GRAY ZONE). HISTORICAL RESULTS WITH ARCHITECT ANALYZER: ON (B)(6) 2025, RESULT= 126.20 U/ML , ON (B)(6) 2025, RESULT= 129.93 U/ML, ON (B)(6) 2025, RESULT= 121.91 U/ML, ON (B)(6) 2025, RESULT= 126.94 U/ML, ON (B)(6) 2025, RESULT= 101.97 U/ML , ON (B)(6) 2025, RESULT= 100.72 U/ML, ON (B)(6) 2025, RESULT= 128.33 U/ML; REPEAT RESULT= 130.32 U/ML, THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 02K91-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 02K91-33, WITH 510K/PMA/BLA NUMBER K052000. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.