ALINITY I CA 19-9XR REAGENT KIT

Additional Manufacturer Narrative

A REVIEW OF COMPLAINTS FOR ALINITY I CA 19-9XR (LOT 68329FP00) ASSAY DETERMINED THAT THERE ARE NO TRENDS FOR THE PRODUCT RELATED TO PATIENT RESULTS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. HISTORICAL PERFORMANCE IN THE FIELD OF REAGENT LOTS USING WORLD-WIDE DATA WAS EVALUATED. THE PATIENT MEDIAN RESULT FOR LOT 68329FP00 WAS ANALYZED AND FOUND TO BE WITHIN ESTABLISHED BASELINES AND CONFIRMS NO SYSTEMIC ISSUES FOR THIS LOT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I CA 19-9XR (LOT 68329FP00) ASSAY. SECTION A1 PATIENT IDENTIFIER COMPLETE SID: (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P32-30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-31, WITH 510K/PMA/BLA NUMBER K052000.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I CA 19-9XR RESULT ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 SID (B)(6) = 68.48 / 24.10 U/ML, ANOTHER ALINITY = 15.73 U/ML. A PREVIOUS VALUE WAS NEGATIVE. IT IS UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

SECTION A2 AND A3A UPDATED WITH AGE/SEX. SECTION B5 UPDATED WITH ADDITIONAL INFORMATION: THIS PATIENT HAS NOT BEEN DIAGNOSED WITH PANCREATIC CANCER. PER ABBOTT'S IFU: THE ALINITY I CA 19-9XR ASSAY IS TO BE USED AS AN AID IN THE MANAGEMENT OF PANCREATIC CANCER PATIENTS IN CONJUNCTION WITH OTHER CLINICAL METHODS. THIS DOES NOT CHANGE THE DEVICE EVALUATION BELOW. A REVIEW OF COMPLAINTS FOR ALINITY I CA 19-9XR (LOT 68329FP00) ASSAY DETERMINED THAT THERE ARE NO TRENDS FOR THE PRODUCT RELATED TO PATIENT RESULTS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. HISTORICAL PERFORMANCE IN THE FIELD OF REAGENT LOTS USING WORLD-WIDE DATA WAS EVALUATED. THE PATIENT MEDIAN RESULT FOR LOT 68329FP00 WAS ANALYZED AND FOUND TO BE WITHIN ESTABLISHED BASELINES AND CONFIRMS NO SYSTEMIC ISSUES FOR THIS LOT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I CA 19-9XR (LOT 68329FP00) ASSAY. SECTION A1 PATIENT IDENTIFIER COMPLETE SID: (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P32-30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-31, WITH 510K/PMA/BLA NUMBER K052000.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I CA 19-9XR RESULT ON AN 84-YR OLD MALE PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 SID (B)(6) = 68.48 / 24.10 U/ML, ANOTHER ALINITY = 15.73 U/ML. A PREVIOUS VALUE WAS NEGATIVE. THE PATIENT HAS NOT BEEN DIAGNOSED WITH PANCREATIC CANCER, BUT WITH ASCENDING COLON CANCER, STAGE IIIA. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.