ALINITY I CA 19-9XR REAGENT KIT

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY CA 19-9XR RESULT GENERATED ON THE ALINITY I AM PROCESSING MODULE FOR ONE PATIENT WITH A HISTORY OF PANCREATIC CANCER. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025, SID (B)(6): INITIAL CA 19-9 RESULT = > 4000 U/ML. REPEAT CA 19-9 RESULT ON ANOTHER ALINITY I ((B)(6)) = 4438.19 U/ML (REPORTED TO THE DOCTOR). DUE TO THE ELEVATED CA 19-9 RESULT, THE PATIENT¿S SURGERY WAS CANCELLED. IT IS NOT KNOWN WHAT TYPE OF SURGERY WAS CANCELLED AND IF THE SURGERY WAS RESCHEDULED. THE CUSTOMER STATED THAT THE PATIENT WAS TESTED AT A NEIGHBORING FACILITY ((B)(6)) ON (B)(6) 2025 AND OBTAINED A CA 19-9 RESULT OF 600. THERE WAS NO FURTHER 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.

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 A RETAINED ALINITY I CA 19-9XR REAGENT KIT LOT 70428FP00. 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. A REVIEW OF TRACKING AND TRENDING DID IDENTIFY AN INCREASE IN COMPLAINTS FOR THE ALINITY I CA 19-9XR ASSAY, LIST NUMBER 8P32, HOWEVER, AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 70428FP00 WAS NOT IDENTIFIED. ADDITIONALLY, IN-HOUSE ACCURACY TESTING WAS COMPLETED USING PANELS WHICH MIMIC PATIENT SAMPLES USING A RETAINED KIT OF LOT NUMBER 70428FP00. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON LOT 70428FP00 WHICH DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ALINITY I CA 19-9XR REAGENT LOT 70428FP00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY CA 19-9XR RESULT GENERATED ON THE ALINITY I PROCESSING MODULE FOR ONE PATIENT WITH A HISTORY OF PANCREATIC CANCER. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025, SID (B)(6): INITIAL CA 19-9 RESULT = > 4000 U/ML. REPEAT CA 19-9 RESULT ON ANOTHER ALINITY I (SN (B)(6) = 4438.19 U/ML (REPORTED TO THE DOCTOR) DUE TO THE ELEVATED CA 19-9 RESULT, THE PATIENT¿S SURGERY WAS CANCELLED. IT IS NOT KNOWN WHAT TYPE OF SURGERY WAS CANCELLED AND IF THE SURGERY WAS RESCHEDULED. THE CUSTOMER STATED THAT THE PATIENT WAS TESTED AT A NEIGHBORING FACILITY (B)(6) ON (B)(6)2025 AND OBTAINED A CA 19-9 RESULT OF 600. THERE WAS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.