ALINITY I CA 19-9XR REAGENT KIT

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I CA 19-9XR RESULTS FOR ONE PATIENT BEING MONITORED FOR PANCREATIC CANCER TREATMENT AFTER UNDERGONE SURGERY IN (B)(6) 2025. THE PATIENT STATED THAT THE RESULTS BEFORE (B)(6) 2025 AND AFTER APRIL 2025 WERE OK, HOWEVER, THE PATIENT QUESTIONED THE RESULT ON APRIL 15 THAT GENERATED THE > FLAG AND BELIEVED THE RESULT TO BE TOO HIGH. THE FOLLOWING DATA WAS PROVIDED: (B)(4), (B)(6) 2025, 16:56 = RESULT REPORTED: 22.32 U/ML. (B)(4), (B)(6) 2025, 14:40 = RESULT REPORTED: >1200.00 U/ML (RAW VALUE = 10285.175 U/ML). (B)(4), (B)(6) 2025, 15:16 = RESULT REPORTED: >1200.00 U/ML (RAW VALUE = 10177.756 U/ML). (B)(4), (B)(6) 2025, 15:49 = RESULT REPORTED: >12000.00 U/ML (DILUTION 1:10) (RAW VALUE =14058.834 U/ML). (B)(4), (B)(6) 2025, 16:28 = RESULT REPORTED:15050.41 U/ML (MANUAL DILUTION). (B)(4), (B)(6) 2025, 15:20 = RESULT REPORTED: 31.62 U/ML. (B)(4), (B)(6) 2025, 14:15 = RESULT REPORTED: 17.69 U/ML. 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)/ (B)(6)/ (B)(6)/ (B)(6)(DIFFERENT SAMPLE DRAWS FROM SAME PATIENT). 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, 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. 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 DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT. THE OVERALL PERFORMANCE OF REAGENT LOT 70432FP00 WAS EVALUATED USING WORLDWIDE DATA FROM CUSTOMERS IN THE FIELD. PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS REVIEW DID NOT IDENTIFY ANY UNUSUAL REAGENT LOT PERFORMANCE FOR LOT 70432FP00. A REVIEW OF LABELING WAS PERFORMED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. A REVIEW OF THE PATIENT'S HISTORY, BACKGROUNDS, MEDICATIONS, AND COMORBIDITIES WAS PERFORMED. BASED ON THE AVAILABLE CLINICAL INFORMATION, THE ELEVATED CA 19-9 LEVEL IN THIS PATIENT APPEARS TO BE MULTIFACTORIAL AND LIKELY ATTRIBUTABLE TO UNDERLYING NONMALIGNANT CONDITIONS RATHER THAN TUMOR RECURRENCE. THE PATIENT¿S COMPLEX MEDICAL HISTORY, INCLUDING CHRONIC LIVER DISEASE, POST CHOLECYSTECTOMY BILIARY CHANGES, DIABETES MELLITUS, GASTROINTESTINAL INFLAMMATION, AND OTHER CHRONIC INFLAMMATORY STATES, PROVIDES A PLAUSIBLE AND CLINICALLY SUPPORTED EXPLANATION FOR BOTH THE MARKED INCREASE AND SUBSEQUENT DECLINE IN CA 19-9 LEVELS. 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 FOR ONE PATIENT BEING MONITORED FOR PANCREATIC CANCER TREATMENT AFTER UNDERGONE SURGERY IN (B)(6) 2025. THE PATIENT STATED THAT THE RESULTS BEFORE (B)(6) 2025 AND AFTER (B)(6) 2025 WERE OK, HOWEVER, THE PATIENT QUESTIONED THE RESULT ON (B)(6) THAT GENERATED THE > FLAG AND BELIEVED THE RESULT TO BE TOO HIGH. THE FOLLOWING DATA WAS PROVIDED: (B)(6), (B)(6) 2025, 16:56 = RESULT REPORTED: 22.32 U/ML, (B)(6), (B)(6) 2025, 14:40 = RESULT REPORTED: >1200.00 U/ML (RAW VALUE = 10285.175 U/ML), (B)(6), (B)(6) 2025, 15:16 = RESULT REPORTED: >1200.00 U/ML (RAW VALUE = 10177.756 U/ML), (B)(6), (B)(6) 2025, 15:49 = RESULT REPORTED: >12000.00 U/ML (DILUTION 1:10) (RAW VALUE =14058.834 U/ML), (B)(6) , (B)(6) 2025, 16:28 = RESULT REPORTED:15050.41 U/ML (MANUAL DILUTION), (B)(6), (B)(6) 2025, 15:20 = RESULT REPORTED: 31.62 U/ML (B)(6), (B)(6) 2025, 14:15 = RESULT REPORTED: 17.69 U/ML ., THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.