ALINITY I CA 19-9XR REAGENT KIT

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I CA 19-9XR RESULTS GENERATED ON THE ALINITY I PROCESSING MODULE FOR MULTIPLE PATIENTS. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: < 37 U/ML): ON (B)(6) 2025: SID (B)(6), INITIAL CA19-9 RESULT = 52.71 U/ML, REPEAT CA19-9 RESULT 2.10 U/ML. OTHER TESTING COMPLETED: CEA RESULTS = < 1.73 AND < 1.73 NG/ML. ON (B)(6) 2025: SID (B)(6), INITIAL CA 19-9 RESULT = 90.73 U/ML, REPEAT CA 19-9 RESULT = 2.65 U/ML. OTHER TESTING COMPLETED: CEA RESULT = < 1.73 NG/ML. THE CUSTOMER IS A SCREENING CENTER AND IS UNABLE TO OBTAIN ADDITIONAL PATIENT INFORMATION, THEREFORE, IT IS UNKNOWN IF THE PATIENTS HAVE BEEN DIAGNOSED WITH PANCREATIC CANCER. 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. A1 - PATIENT IDENTIFIER: (B)(6) (2 DIFFERENT PATIENTS). 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 FIELD DATA 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 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 70432FP00. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH LOT 70432FP00 AND THE COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF THE ALINITY I CA 19-9XR REAGENT LOT 70432FP00 IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR LOT 70432FP00 IS WITHIN THE ESTABLISHED CONTROL LIMITS, INDICATING NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. USE ERROR MAY HAVE CONTRIBUTED TO THE CUSTOMER¿S ISSUE, AS RETESTS WITH THE SAME SAMPLE GAVE EXPECTED NEGATIVE RESULTS, INDICATING A POSSIBLE SAMPLE HANDLING/INTEGRITY ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ALINITY I CA 19-9XR REAGENT LOT 70432FP00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I CA 19-9XR RESULTS GENERATED ON THE ALINITY I PROCESSING MODULE FOR MULTIPLE PATIENTS. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: < 37 U/ML): (B)(6) 2025: SID (B)(6). INITIAL CA19-9 RESULT = 52.71 U/ML. REPEAT CA19-9 RESULT 2.10 U/ML. OTHER TESTING COMPLETED: CEA RESULTS = < 1.73 AND < 1.73 NG/ML. (B)(6) 2025: SID (B)(6). INITIAL CA 19-9 RESULT = 90.73 U/ML. REPEAT CA 19-9 RESULT = 2.65 U/ML. OTHER TESTING COMPLETED: CEA RESULT = < 1.73 NG/ML. THE CUSTOMER IS A SCREENING CENTER AND IS UNABLE TO OBTAIN ADDITIONAL PATIENT INFORMATION, THEREFORE, IT IS UNKNOWN IF THE PATIENTS HAVE BEEN DIAGNOSED WITH PANCREATIC CANCER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.