ALINITY I CA 19-9XR REAGENT KIT

Additional Manufacturer Narrative

SECTION A1 PATIENT IDENTIFIER COMPLETE INFORMATION: (B)(6). 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 8P32-30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21, 510K K052000. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I CA 19-9XR RESULTS FOR A 57-YEAR-OLD MALE PATIENT WITH A HISTORY OF PANCREATIC HEAD CANCER. THE CUSTOMER REPORTS POOR DILUTION LINEARITY WHEN PERFORMING SERIAL DILUTIONS USING THE CA 19-9 ASSAY. THE FOLLOWING RESULTS FOR SID (B)(6) WERE PROVIDED: (B)(6) 2026 INITIAL RESULT >1,200.00 U/ML, (B)(6) 2026 REPEAT RESULT = 737.75 U/ML, REPEAT WITH 1:2 DILUTION = 681.43 U/ML, 1:4 DILUTION RESULT = 258.83 U/ML, 1:8 DILUTION RESULT = 108.95 U/ML, 1:16 DILUTION RESULT = 48.21 U/ML, 1:32 DILUTION RESULT = 26.75 U/ML, 1:64 DILUTION RESULT = 14.01 U/ML. REFERENCE LAB TESTING: REPRODUCIBILITY TESTING WERE AROUND THE SAME AS THE VALUES OBTAINED AT THE CUSTOMER'S FACILITY. THE RESULTS OF THE DILUTION LINEARITY TEST SHOWED SATISFACTORY DILUTION LINEARITY A MARKED DECREASE IN MEASURED VALUES AFTER CONDUCTING TREATMENT WITH NEURAMINIDASE. THE PATIENT HAS A HISTORY OF PANCREATIC HEAD RESECTION SURGERY ON (B)(6) 2025 FOLLOWED BY CHEMOTHERAPY. PATIENT¿S HISTORICAL RESULTS PROVIDED: (B)(6) 2025 SID (B)(6) RESULT = 89.85 U/ML, (B)(6) 2025 SID (B)(6) RESULT = 164.37 U/ML, (B)(6) 2026 SID (B)(6) RESULT = 433.94 U/ML, (B)(6) 2026 SID (B)(6) RESULT = 893.94 U/ML, (B)(6) 2026 SID (B)(6) RESULT = 1,459.59 U/ML. ADDITIONAL LAB RESULTS PROVIDED: CEA RESULTS: (B)(6) 2025 RESULT = 3.65, (B)(6) 2025 RESULT = 3.53, (B)(6) 2026 RESULT = 5.31, (B)(6) 2026 RESULT = 8.10, (B)(6) 2026 RESULT = 14.09, (B)(6) 2026 RESULT = 8.90. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ALINITY I 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. 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 AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 78763FP00. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES, OR DEVIATIONS ASSOCIATED WITH THE LOT NUMBER AND COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF ALINITY I CA 19-9XR REAGENT WAS REVIEWED USING WORLDWIDE FIELD DATA. THE PATIENT¿S DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR LOT 78763FP00 IS WITHIN THE ESTABLISHED CONTROL LIMITS. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED FOR THE LOT 78763FP00. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I CA 19-9XR ASSAY FOR LOT 78763FP00 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I CA 19-9XR RESULTS FOR A 57-YEAR-OLD MALE PATIENT WITH A HISTORY OF PANCREATIC HEAD CANCER. THE CUSTOMER REPORTS POOR DILUTION LINEARITY WHEN PERFORMING SERIAL DILUTIONS USING THE CA 19-9 ASSAY. THE FOLLOWING RESULTS FOR SID (B)(6) WERE PROVIDED: (B)(6) 2026 INITIAL RESULT >1,200.00 U/ML, (B)(6) 2026 REPEAT RESULT = 737.75 U/ML, REPEAT WITH 1:2 DILUTION = 681.43 U/ML, 1:4 DILUTION RESULT = 258.83 U/ML, 1:8 DILUTION RESULT = 108.95 U/ML, 1:16 DILUTION RESULT = 48.21 U/ML, 1:32 DILUTION RESULT = 26.75 U/ML, 1:64 DILUTION RESULT = 14.01 U/ML. REFERENCE LAB TESTING: REPRODUCIBILITY TESTING WERE AROUND THE SAME AS THE VALUES OBTAINED AT THE CUSTOMER'S FACILITY THE RESULTS OF THE DILUTION LINEARITY TEST SHOWED SATISFACTORY DILUTION LINEARITY A MARKED DECREASE IN MEASURED VALUES AFTER CONDUCTING TREATMENT WITH NEURAMINIDASE. THE PATIENT HAS A HISTORY OF PANCREATIC HEAD RESECTION SURGERY ON (B)(6) 2025 FOLLOWED BY CHEMOTHERAPY. PATIENT¿S HISTORICAL RESULTS PROVIDED: (B)(6) 2025 SID (B)(6) RESULT = 89.85 U/ML, (B)(6) 2025 SID (B)(6) RESULT = 164.37 U/ML, (B)(6) 2026 SID (B)(6) RESULT = 433.94 U/ML, (B)(6) 2026 SID (B)(6) RESULT = 893.94 U/ML, (B)(6) 2026 SID (B)(6) RESULT = 1,459.59 U/ML. ADDITIONAL LAB RESULTS PROVIDED: CEA RESULTS: (B)(6) 2025 RESULT = 3.65, (B)(6)2025 RESULT = 3.53, (B)(6) 2026 RESULT = 5.31, (B)(6) 2026 RESULT = 8.10, (B)(6) 2026 RESULT = 14.09, (B)(6) 206 RESULT = 8.90. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.