ALINITY I CA 19-9XR REAGENT KIT

Additional Manufacturer Narrative

COMPLETE ENTRY FOR SECTION A1 - PATIENT IDENTIFIER: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P32-30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21, WITH 510K NUMBER K052000. 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 FALSELY ELEVATED ALINITY I CA 19-9XR FOR TWO PATIENTS. THE PATIENT RESULTS INITIALLY WERE POSITIVE, AFTER A 1:10 DILUTION THE RESULTS WERE NEGATIVE. THE PATIENTS HAVE A HISTORICAL RESULT OF BEING NEGATIVE. THE SAMPLES WERE RECENTRIFUGED AND REPEATED AND THE RESULTS WERE NEGATIVE. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025, SID (B)(6), INITIAL RESULT= 59, REPEAT RESULT (1:10 DILUTION)= <20.60, 7 AND 7. ADDITIONAL RESULTS PROVIDED: SODIUM RESULT= 137, POTASSIUM RESULT= 4.1; BIC RESULT= 23; UREA RESULT= 4.8; CREATININE RESULT= 46; TOTAL PROTEIN RESULT= 68 THERE WAS NO IMPACT TO PATIENT MANAGEMENT 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, FIELD DATA REVIEW AND LABELING REVIEW. 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 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 69362FP00. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES, NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT 69362FP00. THE OVERALL PERFORMANCE OF ALINITY I CA 19-9XR REAGENTS WAS REVIEWED USING FIELD DATA FROM CUSTOMERS WORLDWIDE CUSTOMERS WORLDWIDE. REVIEW OF THE DATA ASSOCIATED WITH REAGENT LOT 69362FP00 INDICATE THE PATIENT MEDIANS ARE WITHIN THE ESTABLISHED LIMITS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I CA 19-9XR REAGENT LOT 69362FP00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I CA 19-9XR FOR TWO PATIENTS. THE PATIENT RESULTS INITIALLY WERE POSITIVE, AFTER A 1:10 DILUTION THE RESULTS WERE NEGATIVE. THE PATIENTS HAVE A HISTORICAL RESULT OF BEING NEGATIVE. THE SAMPLES WERE RECENTRIFUGED AND REPEATED AND THE RESULTS WERE NEGATIVE. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025, SID (B)(6), INITIAL RESULT= 59, REPEAT RESULT (1:10 DILUTION) = <20.60, 7 AND 7. ADDITIONAL RESULTS PROVIDED: SODIUM RESULT= 137, POTASSIUM RESULT= 4.1; BIC RESULT= 23; UREA RESULT= 4.8; CREATININE RESULT= 46; TOTAL PROTEIN RESULT= 68. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.