ALINITY I CA 19-9XR REAGENT KIT

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I CA 19-9XR RESULTS FOR ONE PATIENT SAMPLE GENERATED ON THE ALINITY I AM PROCESSING MODULE. THE CUSTOMER STATED THAT THE PATIENT IS DIAGNOSED WITH PANCREATIC CANCER. TUMOR MARKERS ARE TESTED FOR THE PATIENT AT REGULAR INTERVALS. THE FOLLOWING DATA WAS PROVIDED: SID: (B)(6): INITIAL RESULT = 215.2 U/ML; REPEATED ON ANOTHER ANALYZER (SN: (B)(6) = 3.2 U/ML ON (B)(6) 2025, REPEATED THE SAMPLE AGAIN ON BOTH MODULES FOR CA 19-9: SN: (B)(6) = 29.843 U/ML, SN: (B)(6) = 3.266 U/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. 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.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION 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 OF THE COMPLAINT LOT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. 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 DATA FOR THE ALINITY I CA 19-9XR ASSAY (LIST NUMBER 08P32) DID IDENTIFY AN INCREASE IN COMPLAINTS, HOWEVER, AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 69363FP00 WAS NOT IDENTIFIED. ADDITIONALLY, ACCURACY TESTING WAS PERFORMED UTILIZING A RETAINED KIT OF COMPLAINT LOT 69363FP00. THE TESTING MEETS ALL VALIDITY AND ACCEPTANCE CRITERIA WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. THE DEVICE HISTORY RECORD WAS REVIEWED AND DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT 69363FP00. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ALINITY I CA 19-9XR REAGENT LOT 69363FP00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I CA 19-9XR RESULTS FOR ONE PATIENT SAMPLE GENERATED ON THE ALINITY I PROCESSING MODULE. THE CUSTOMER STATED THAT THE PATIENT IS DIAGNOSED WITH PANCREATIC CANCER. TUMOR MARKERS ARE TESTED FOR THE PATIENT AT REGULAR INTERVALS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL RESULT = 215.2 U/ML; REPEATED ON ANOTHER ANALYZER (SN (B)(6) = 3.2 U/ML. ON (B)(6)2025, REPEATED THE SAMPLE AGAIN ON BOTH MODULES FOR CA 19-9: SN (B)(6) = 29.843 U/ML. SN (B)(6) = 3.266 U/ML . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.