ALINITY I CA 19-9XR REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED ERRATIC ALINITY I CA 19-9XR FOR ONE PATIENT WITH A HISTORY OF PANCREATIC CANCER. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025, SID (B)(6), INITIAL CA 19-9 RESULT >1200 U/ML; REPEAT RESULT (AUTODILUTION) = 773.21 U/ML; REPEAT RESULT (MANUAL DILUTION 1:2) = 1146.16 U/ML; REPEAT RESULT (MANUAL DILUTION 1:3) = 848.28 U/ ML; ECLIA METHOD, AT ANOTHER SITE= 500 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P32-20 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21/31, WITH 510K NUMBER K052000. COMPLETE ENTRY FOR SECTION A1 - PATIENT IDENTIFIER: (B)(6). 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.

Description of Event or Problem

THE CUSTOMER OBSERVED ERRATIC ALINITY I CA 19-9XR FOR ONE PATIENT WITH A HISTORY OF PANCREATIC CANCER. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2025, SID (B)(6), INITIAL CA 19-9 RESULT >1200 U/ML; REPEAT RESULT (AUTODILUTION)= 773.21 U/ML; REPEAT RESULT (MANUAL DILUTION 1:2) = 1146.16 U/ML; REPEAT RESULT (MANUAL DILUTION 1:3) = 848.28 U/ ML; ECLIA METHOD, AT ANOTHER SITE= 500 U/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, IN HOUSE TESTING AND LABELING REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT 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 67280FP00. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE COMPLAINT LOT WHICH DID NOT SHOW ANY NON-CONFORMANCES, DEVIATIONS, OR POTENTIAL NON-CONFORMANCES. IN-HOUSE ACCURACY TESTING WAS COMPLETED USING A RETAINED KIT OF COMPLAINT LOT NUMBER 67280FP00. ACCEPTANCE CRITERIA WAS MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I CA 19-9XR REAGENT LOT 67280FP00 WAS IDENTIFIED.