ALINITY I CA 19-9XR REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I CA 19-9XR RESULT FOR TWO PATIENT SAMPLES. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 SID (B)(6) INITIAL RESULT = 84.28 U/ML, REPEAT RESULTS 31.75 U/ML, SAME PATIENT WITH SID (B)(6) = 25.39 U/ML, ADDITIONAL REPEAT RESULTS AFTER CUSTOMER CHANGED THE PROBE = 25.14 U/ML AND 24.98 U/ML (B)(6) 2025 SID (B)(6) INITIAL RESULT 45.66 U/ML, REPEAT RESULT 30.92 U/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

SECTION A1 PATIENT IDENTIFIER COMPLETE INFORMATION: (B)(6). SECTION E1 PHONE NUMBER 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 8P32-20 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21 / 31, WITH 510K/PMA/BLA NUMBER 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 RESULT FOR TWO PATIENT SAMPLES. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 SID (B)(6) INITIAL RESULT = 84.28 U/ML, REPEAT RESULTS 31.75 U/ML, SAME PATIENT WITH SID (B)(6) = 25.39 U/ML, ADDITIONAL REPEAT RESULTS AFTER CUSTOMER CHANGED THE PROBE = 25.14 U/ML AND 24.98 U/ML. (B)(6) 2025 SID (B)(6) INITIAL RESULT 45.66 U/ML, REPEAT RESULT 30.92 U/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR FALSE 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 IN HOUSE TESTING. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORTED THE COMPLAINT 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 68328FP00. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, DEVIATIONS, OR POTENTIAL NON-CONFORMANCES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. ACCURACY TESTING WAS PERFORMED TO EVALUATE THE PERFORMANCE OF THE REAGENT LOT 68328FP00. AN INTERNAL CA 19-9XR PANEL WAS TESTED WITH RETAINED KITS OF THE LIKELY CAUSE REAGENT LOT. ACCEPTANCE CRITERIA WAS MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I CA 19-9XR ASSAY FOR LOT 68328FP00 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.