ALINITY I CA 19-9XR REAGENT KIT

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 8P32-21 / 31, 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 RESULTS GENERATED BY THE ALINITY I PROCESSING MODULE FOR A FEMALE PATIENT UNDERGOING A PHYSICAL EXAMINATION. THE PATIENT DOES NOT HAVE PANCREATIC CANCER. THE CUSTOMER STATED THE PATIENT HAD BEEN TESTED SEVERAL TIMES BETWEEN 2020 TO 2024, AND THE ALINITY I CA 19-9XR RESULTS WERE ELEVATED, WITH VALUES RANGING FROM 50 TO 110 U/ML. DUE TO THE FALSELY ELEVATED ALINITY I CA 9-9XR RESULTS, THE PATIENT UNDERWENT AN UPPER ABDOMINAL CT SCAN AND ENHANCED GASTROSCOPY, WITH NO SIGNIFICANT ABNORMALITIES FOUND. IT WAS REPORTED THE PATIENT DID NOT RECEIVE IV CONTRAST, AND THERE WAS NO HARM TO THE PATIENT. THE PATIENT WENT TO GET TESTED AT ANOTHER HOSPITAL THAT UTILIZED THE BECKMAN PLATFORM, AND A NORMAL RESULT WAS OBTAINED. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S NORMAL RANGE: <37 U/ML (B)(6) 2025 ALINITY I CA 19-9XR RESULT = 115.91 U/ML PREVIOUS ALINITY I CA 19-9XR RESULTS BETWEEN 2020 TO 2024 = 50 TO 110 U/ML BECKMAN PLATFORM RESULT (B)(6) 2025) = NORMAL. THE CUSTOMER IS QUESTIONING ALL THE RESULTS FROM 2020 TO 2025. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

SECTION B5 - DESCRIBE EVENT OR PROBLEM: THIS SECTION WAS UPDATED WITH A MEDICAL OPINION OBTAINED ON (B)(6) 2025. A MEDICAL OPINION WAS OBTAINED TO RE-EVALUATE THE INFORMATION PROVIDED BY THE CUSTOMER. THE MEDICAL OPINION STATES THAT, BASED ON THE REPORT OF NO PATIENT HARM DUE TO THE PROCEDURES AND NO IMPACT ON PATIENT MANAGEMENT, THIS INCIDENT DOES NOT CONSTITUTE A SERIOUS INJURY. SINCE THE PATIENT DOES NOT HAVE PANCREATIC CANCER, USING THE PRODUCT OFF-LABEL IS NOT REPORTABLE. THIS INCIDENT IS NO LONGER CONSIDERED A SERIOUS INJURY OR REPORTABLE; THEREFORE, NO FURTHER REPORTS WILL BE PROVIDED.

Description of Event or Problem

UPDATED ON (B)(6) 2025: A MEDICAL OPINION WAS OBTAINED TO RE-EVALUATE THE INFORMATION PROVIDED BY THE CUSTOMER. THE MEDICAL OPINION STATES THAT BASED ON THE REPORT OF NO PATIENT HARM DUE TO THE PROCEDURES AND NO IMPACT TO PATIENT MANAGEMENT REPORTED, THIS INCIDENT DOES NOT CONSTITUTE A SERIOUS INJURY.