ALINITY I CA 19-9XR REAGENT KIT
Received Mar 26, 2026 · Event occurred Mar 16, 2026
Report 3002809144-2026-00072 · MDR key 24697780
Device
Generic name
System, Test, Carbohydrate Ag (ca19-9), For Monit And Mgmt Of Pancreatic Cancer
Manufacturer
Abbott GmbhCatalog number
08P32-74
Lot number
78764FP00
Product problems
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I CA 19-9XR RESULTS ON A PATIENT WHO HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. RESULTS WERE NOT REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6); INITIAL RESULT = >1200 U/ML, REPEAT RESULT =708 U/ML (AUTO DILUTION), 1758.48 U/ML (MANUAL DILUTION 2X), 1117.47 U/ML (MANUAL DILUTION 3X), 756.23 U/ML (MANUAL DILUTION 10X). NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I CA 19-9XR REAGENT LOT 78764FP00 TO ADDRESS THE CUSTOMER¿S OBSERVATION OF FALSELY ELEVATED RESULTS. REVIEW OF TRACKING AND TRENDING BY LIST NUMBER AND BY COMPLAINT LOT DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. HISTORICAL PERFORMANCE OF REAGENT LOT 78763FP00 (SIBLING LOT OF 78764FP00) WAS EVALUATED USING WORLDWIDE FIELD DATA FOR THE ALINITY I CA 19-9XR ASSAY. THE PATIENT¿S DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR LOT 78763FP00 IS WITHIN THE ESTABLISHED CONTROL LIMITS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I CA 19-9XR REAGENT LOT 78764FP00.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I CA 19-9XR RESULTS ON A PATIENT WHO HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. RESULTS WERE NOT REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6); INITIAL RESULT = >1200 U/ML, REPEAT RESULT =708 U/ML (AUTO DILUTION), 1758.48 U/ML (MANUAL DILUTION 2X), 1117.47 U/ML (MANUAL DILUTION 3X), 756.23 U/ML (MANUAL DILUTION 10X). NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. 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. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.