ALINITY I CA 19-9XR REAGENT KIT

Additional Manufacturer Narrative

A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I CA 19-9XR REAGENT LOT 74581FP00 TO ASSESS THE CUSTOMER¿S OBSERVATION OF FALSELY ELEVATED RESULTS. THE PATIENT RESULTS OBTAINED ON THE ALINITY WERE BEING COMPARED AGAINST PATIENT RESULTS FROM ANOTHER METHOD. VALUES OBTAINED WITH DIFFERENT ASSAY METHODS CANNOT BE USED INTERCHANGEABLY. REVIEW OF TRACKING AND TRENDING BY LIST NUMBER AND BY COMPLAINT LOT DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. ACCURACY TESTING WAS PERFORMED TO EVALUATE THE PERFORMANCE OF THE REAGENT LOT 74581FP00. AN INTERNAL CA 19-9XR PANEL WAS TESTED WITH RETAINED KITS OF REAGENT LOT 74581FP00. ACCEPTANCE CRITERIA WAS MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I CA 19-9XR REAGENT LOT 74581FP00 WAS IDENTIFIED. BASED ON THE INFORMATION WITHIN THE COMPLAINT RECORD, THE DEVICE MET PERFORMANCE SPECIFICATIONS AND PERFORMED AS INTENDED AT THE CUSTOMER SITE.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I CA 19-9XR RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A 73-YEAR-OLD FEMALE PATIENT UNDERGOING TREATMENT FOR PANCREATIC CANCER. THE PHYSICIAN QUESTIONED THE RESULT BECAUSE THE PATIENT¿S CLINICAL SYMPTOMS HAD IMPROVED, AND A RECENT COMPUTED TOMOGRAPHY (CT) SCAN SHOWED NO SIGNS OF DISEASE. IT WAS NOTED THAT THE CT SCAN WAS PERFORMED BASED ON THE PATIENT¿S CLINICAL CONDITION. THE PATIENT WAS TESTED ON OTHER PLATFORMS YIELDING LOWER RESULT VALUES. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): (B)(6) 2025 ALINITY I CA 19-9XR RESULT = 1337.95 IU/ML (REFERENCE RANGE: <37 IU/ML) SNIBE PLATFORM = 99 IU/ML ROCHE PLATFORM (B)(6) 2025) = AROUND 100 IU/ML (REFERENCE RANGE: <37 IU/ML) PREVIOUS ALINITY I CA 19-9XR RESULTS: (B)(6) 2025 CA 19-9 RESULT = 614.92 IU/ML, (B)(6) 2025 CA 19-9 RESULT = 402.05 IU/ML, (B)(6) 2025 CA 19-9 RESULT = 311.81 IU/ML, (B)(6) 2025 CA 19-9 RESULT = 263.44 IU/ML, (B)(6) 2025 CA 19-9 RESULT = 457.29 IU/ML, (B)(6) 2025 CA 19-9 RESULT = 641.39 IU/ML, (B)(6) 2025 CA 19-9 RESULT = 2740.95 IU/ML, (B)(6) 2025 CA 19-9 RESULT = 4157.7 IU/ML, (B)(6) 2025 CA 19-9 RESULT = >12000 IU/ML, (B)(6) 2025 CA 19-9 RESULT = >12000 IU/ML, (B)(6) 2025 CA 19-9 RESULT = >12000 IU/ML . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P32-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 08P32-21, 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 REPORTED FALSELY ELEVATED ALINITY I CA 19-9XR RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A 73-YEAR-OLD FEMALE PATIENT UNDERGOING TREATMENT FOR PANCREATIC CANCER. THE PHYSICIAN QUESTIONED THE RESULT BECAUSE THE PATIENT¿S CLINICAL SYMPTOMS HAD IMPROVED, AND A RECENT COMPUTED TOMOGRAPHY (CT) SCAN SHOWED NO SIGNS OF DISEASE. IT WAS NOTED THAT THE CT SCAN WAS PERFORMED BASED ON THE PATIENT¿S CLINICAL CONDITION. THE PATIENT WAS TESTED ON OTHER PLATFORMS YIELDING LOWER RESULT VALUES. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): ON (B)(6) 2025 ALINITY I CA 19-9XR RESULT = 1337.95 IU/ML (REFERENCE RANGE: <37 IU/ML) SNIBE PLATFORM = 99 IU/ML. ROCHE PLATFORM (B)(6) 2025) = AROUND 100 IU/ML (REFERENCE RANGE: <37 IU/ML). PREVIOUS ALINITY I CA 19-9XR RESULTS: ON (B)(6) 2025 CA 19-9 RESULT = 614.92 IU/ML, ON (B)(6) 2025 CA 19-9 RESULT = 402.05 IU/ML, ON (B)(6) 2025 CA 19-9 RESULT = 311.81 IU/ML, ON (B)(6) 2025 CA 19-9 RESULT = 263.44 IU/ML, ON (B)(6) 2025 CA 19-9 RESULT = 457.29 IU/ML, ON (B)(6) 2025 CA 19-9 RESULT = 641.39 IU/ML, ON (B)(6) 2025 CA 19-9 RESULT = 2740.95 IU/ML, ON (B)(6) 2025 CA 19-9 RESULT = 4157.7 IU/ML, ON (B)(6) 2025 CA 19-9 RESULT = >12000 IU/ML, ON (B)(6) 2025 CA 19-9 RESULT = >12000 IU/ML, ON (B)(6) 2025 CA 19-9 RESULT = >12000 IU/ML , NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.