ARCHITECT CA19-9XR REAGENT KIT

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER (B)(4) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER (B)(4), WITH 510K/PMA/BLA NUMBER K052000. 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 TICKET SEARCH FOR COMPLAINTS FOR LIKELY CAUSE LOT DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. HISTORICAL PERFORMANCE WAS EVALUATED USING WORLD-WIDE DATA. THE PATIENT¿S DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR LOT 62079FP00 IS WITHIN THE ESTABLISHED CONTROL LIMITS. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED FOR 62079FP00. THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON LOT 62079FP00 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 62079FP00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT CA 19-9XR RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR A 73-YEAR-OLD MALE INPATIENT FOR AN UNSPECIFIED ACUTE CONDITION. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024 RESULT = 13,998 U/ML, REPEAT RESULT THE SAME (NO SPECIFIC DATA PROVIDED). ADDITIONAL LAB RESULTS PROVIDED: IGG: 1900, CRP: 12, RF: 228, NTPROBNP: 215, ANTI-CCP: 144, NO REPEAT RESULTS PROVIDED (B)(6) 2025 RESULT =AS 172.4 U/ML REPEAT RESULT THE SAME (NO SPECIFIC DATA PROVIDED). ADDITIONAL LAB RESULT PROVIDED: CRP ABOUT 0.1. THE CUSTOMER MENTIONED THEY ARE ONLY QUESTIONING THE CA 19-9 RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.