ALINITY I CA 19-9XR REAGENT KIT

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P32-30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21/31, WITH 510K NUMBER K052000. COMPLETE ENTRY FOR SECTION A1 - PATIENT IDENTIFIER: (B)(6) . COMPLETE ENTRY FOR SECTION E1 - PHONE NUMBER: (B)(6) . 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.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I CA 19-9XR FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025, SID (B)(6) , INITIAL CA 19-9 RESULT= 135.36 U/ML; (B)(6) 2025, REPEAT RESULT (ANALYZER (B)(4).= 6.84 U/ML; REPEAT RESULT (ANALYZER (B)(4).= 8.23 U/ML; REPEAT RESULT (ANALYZER (B)(4).= 9.57 U/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I CA 19-9XR FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2025, SID (B)(6), INITIAL CA 19-9 RESULT= 135.36 U/ML; (B)(6) 2025, REPEAT RESULT (ANALYZER (B)(6) = 6.84 U/ML; REPEAT RESULT (ANALYZER (B)(6) = 8.23 U/ML; REPEAT RESULT (ANALYZER (B)(6) = 9.57 U/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, FIELD DATA REVIEW AND LABELING REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER CONFIRM THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUES IDENTIFIED. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I CA 19-9XR ASSAY DID IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE, HOWEVER, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 69362FP00. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES, NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH LOT 69362FP00 AND COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF THE ALINITY I CA 19-9XR 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 69362FP00 IS WITHIN THE ESTABLISHED CONTROL LIMITS. THE HISTORICAL PERFORMANCE OF THE REAGENT LOT WILL BE USED IN PLACE OF RETAINED FILE SAMPLE ANALYSIS. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED FOR THE LOT 69362FP00. LABELLING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I CA 19-9XR REAGENT LOT 69362FP00 WAS IDENTIFIED.