ALINITY I CA 19-9XR REAGENT KIT

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, REVIEW OF THE DEVICE HISTORY RECORD, AND FIELD DATA REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I CA 19-9XR ASSAY DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, NO TRENDS WERE IDENTIFIED FOR LOT 78765FP00. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH LOT 78765FP00 AND COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF THE ALINITY I CA 19-9XR REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED 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 78765FP00 IS WITHIN THE ESTABLISHED CONTROL LIMITS. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED FOR LOT 78765FP00. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ALINITY I CA 19-9XR REAGENT LOT 78765FP00 WAS IDENTIFIED. CORRECTION: UPDATED FOR TYPOGRAPHICAL ERROR WHEN TYPING IN THE CUSTOMER'S NAME. E1: (B)(6).

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I CA 19-9XR RESULT FOR A 78-YEAR-OLD MALE PATIENT WHOSE CONDITION IS NOT KNOWN. THE CUSTOMER NOTED THERE WAS NO INTERVENTION OR TREATMENT BETWEEN THE TIME PERIOD OF THE TWO TESTS. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025: CA 19-9 RESULT = 3703.18, (B)(6) 2026, SID 01789746: CA 19-9 RESULT = 6.97, THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER: 08P32-20 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER: 8P32-21 WITH 510K/PMA/BLA NUMBER: K052000. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I CA 19-9XR RESULT FOR A 78-YEAR-OLD MALE PATIENT WHOSE CONDITION IS NOT KNOWN. THE CUSTOMER NOTED THERE WAS NO INTERVENTION OR TREATMENT BETWEEN THE TIME PERIOD OF THE TWO TESTS. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025: CA 19-9 RESULT = 3703.18. ON (B)(6) 2026, SID: (B)(6): CA 19-9 RESULT = 6.97. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.