ALINITY I CA 19-9XR REAGENT KIT

Additional Manufacturer Narrative

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. 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, WITH 510K NUMBER K052000.

Description of Event or Problem

THE CUSTOMER OBSERVED IMPRECISE ALINITY I CA 19-9XR RESULTS GENERATED BY THE ALINITY I PROCESSING MODULE FOR A PATIENT UNDERGOING TREATMENT FOR PANCREATIC CANCER. THE RESULTS WERE INCONSISTENT WITH BOTH THE ROCHE PLATFORM AND THE PATIENT¿S HISTORICAL BASELINE VALUES. THE FOLLOWING DATA WAS PROVIDED: ALINITY I CA 19-9XR REFERENCE RANGE: UP TO 37 U/ML ROCHE REFERENCE RANGE: <34 U/ML SID (B)(6) (FIRST SAMPLE): (B)(6) 2025 INITIAL ALINITY I CA 19-9XR RESULT = >1200 U/ML DILUTED ALINITY I CA 19-9XR RESULT = 1035.52 U/ML ROCHE RESULT = 225 U/ML SECOND SAMPLE (NEW BLOOD DRAW): (B )(6) 2025 ALINITY I CA 19-9XR RESULT = 970 U/ML MANUAL DILUTION RESULT = 1186 U/ML. FOR TROUBLESHOOTING PURPOSES, THE FIRST SAMPLE (SID (B)(6) WAS SENT TO ANOTHER LAB AND TESTED ON THE ALINITY I PROCESSING MODULE (B)(6), YIELDING A RESULT OF >1200 U/ML. HISTORICAL BASELINES: ALINITY I CA 19-9XR RESULT: AROUND 450 U/ML ROCHE RESULT: 150 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Description of Event or Problem

THE CUSTOMER OBSERVED IMPRECISE ALINITY I CA 19-9XR RESULTS GENERATED BY THE ALINITY I PROCESSING MODULE FOR A PATIENT UNDERGOING TREATMENT FOR PANCREATIC CANCER. THE RESULTS WERE INCONSISTENT WITH BOTH THE ROCHE PLATFORM AND THE PATIENT¿S HISTORICAL BASELINE VALUES. THE FOLLOWING DATA WAS PROVIDED: ALINITY I CA 19-9XR REFERENCE RANGE: UP TO 37 U/ML ROCHE REFERENCE RANGE: <34 U/ML. SID (B)(6) (FIRST SAMPLE): (B)(6) 2025 INITIAL ALINITY I CA 19-9XR RESULT = >1200 U/ML, DILUTED ALINITY I CA 19-9XR RESULT = 1035.52 U/ML, ROCHE RESULT = 225 U/ML. SECOND SAMPLE (NEW BLOOD DRAW): (B)(6) 2025 ALINITY I CA 19-9XR RESULT = 970 U/ML MANUAL DILUTION RESULT = 1186 U/ML. FOR TROUBLESHOOTING PURPOSES, THE FIRST SAMPLE (SID (B)(6) WAS SENT TO ANOTHER LAB AND TESTED ON THE ALINITY I PROCESSING MODULE (B)(6), YIELDING A RESULT OF >1200 U/ML. HISTORICAL BASELINES: ALINITY I CA 19-9XR RESULT: AROUND 450 U/ML ROCHE RESULT: 150 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, FIELD DATA REVIEW AND LABELING REVIEW. 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 75647FP00. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE COMPLAINT LOT WHICH DID NOT SHOW ANY NON-CONFORMANCES, DEVIATIONS, OR POTENTIAL NON-CONFORMANCES. THE OVERALL PERFORMANCE OF ALINITY I CA 19-9XR REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT¿S DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS REVIEW DID NOT IDENTIFY ANY UNUSUAL REAGENT LOT PERFORMANCE FOR THE LOT 75647FP00. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED FOR 75647FP00. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION THE ALINITY I CA 19-9XR REAGENT LOT 75647FP00 IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I CA 19-9XR REAGENT WAS IDENTIFIED.