ALINITY I CA 19-9XR REAGENT KIT
Received Sep 19, 2025 · Event occurred Sep 9, 2025
Report 3002809144-2025-00300 · MDR key 23094945
Device
Generic name
System, Test, Carbohydrate Ag (ca19-9), For Monit And Mgmt Of Pancreatic Cancer
Manufacturer
Abbott GmbhCatalog number
08P32-20
Lot number
75647FP00
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P32 THAT HAS THE SAME PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 08P32, WITH 510K/PMA/BLA NUMBER K052000. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I CA 19-9XR RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A PATIENT. THE SAMPLE WAS REPEATED, AND A LOWER RESULT WAS OBTAINED. IT IS UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025 SID (B)(6) INITIAL RESULT = 40.93 U/ML; REPEAT RESULT = 1.56 U/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
DATA AND INFORMATION PROVIDED WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING DATA FOR THE ALINITY I CA 19-9XR ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINTS RELATED TO THE ISSUE UNDER REVIEW. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR THE REAGENT LOT. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. HISTORICAL PERFORMANCE OF REAGENT LOT 75647FP00 WAS EVALUATED USING WORLDWIDE FIELD DATA FOR ALINITY I CA 19-9XR ASSAY. THE PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS REVIEW IDENTIFIED THAT THE REAGENT LOT PERFORMANCE FOR LOT 75647FP00 WAS ACCEPTABLE. 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 ASSAY WAS IDENTIFIED.
Description of Event or Problem
THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I CA 19-9XR RESULT GENERATED BY THE ALINITY I AM PROCESSING MODULE FOR A PATIENT. THE SAMPLE WAS REPEATED, AND A LOWER RESULT WAS OBTAINED. IT IS UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025, SID (B)(6) INITIAL RESULT = 40.93 U/ML; REPEAT RESULT = 1.56 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.