ALINITY I CA 19-9XR REAGENT KIT

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED RESULTS FOR THE ALINITY CA 19-9XR FOR ONE PATIENT WHO HAS A HISTORY OF PANCREATIC CANCER. THE SAMPLE WAS REPEATED MULTIPLE TIMES. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6) PROCESSED ON (B)(6) 2024 : FIRST RUN >1200U/ML, AUTODILUTION = 579.88 U/ML, MANUAL DILUTION 1:3 = 769.91U/ML, MANUAL DILUTION 1:10 = 507.10 U/ ML. SAMPLE WAS CENTRIFUGED AGAIN AND REPEATED = 520.39 U/ML WHICH IS THE RESULT THE CUSTOMER BELIEVES TO BE CORRECT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR FALSELY 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 FIELD DATA REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 61053FP00. TICKET TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, DEVIATIONS, OR POTENTIAL NON-CONFORMANCES WITH LOT 61053FP00 AND THE COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF ALINITY I CA 19-9XR WAS REVIEWED USING FIELD DATA FROM CUSTOMERS WORLDWIDE. THE PATIENT¿S DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR LOT 61053FP00 IS WITHIN THE ESTABLISHED CONTROL LIMITS. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED FOR 61053FP00. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I CA 19-9XR REAGENT FOR LOT 61053FP00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED RESULTS FOR THE ALINITY CA 19-9XR FOR ONE PATIENT WHO HAS A HISTORY OF PANCREATIC CANCER. THE SAMPLE WAS REPEATED MULTIPLE TIMES. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6) PROCESSED ON (B)(6)2024: FIRST RUN >1200U/ML. AUTODILUTION = 579.88 U/ML. MANUAL DILUTION 1:3 = 769.91U/ML. MANUAL DILUTION 1:10 = 507.10 U/ ML. SAMPLE WAS CENTRIFUGED AGAIN AND REPEATED = 520.39 U/ML WHICH IS THE RESULT THE CUSTOMER BELIEVES TO BE CORRECT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.