ALINITY I CA 19-9XR REAGENT KIT
Received May 8, 2025 · Event occurred Apr 20, 2025
Report 3002809144-2025-00154 · MDR key 21989036
Device
Generic name
System, Test, Carbohydrate Ag (ca19-9), For Monit And Mgmt Of Pancreatic Cancer
Manufacturer
Abbott GmbhCatalog number
08P32-20
Lot number
69363FP00
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I CA 19-9 RESULTS FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) INITIAL RESULT 81.59 U/ML, RETEST 5.58 U/ML AND RETEST ON A DIFFERENT INSTRUMENT 7.04 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, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND TESTING OF A RETAINED REAGENT KIT. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. TICKET SEARCH FOR LOT 69363FP00 DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE ISSUE UNDER REVIEW. TICKET TRENDING REVIEW FOUND NO TRENDS RELATED TO THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. ACCURACY TESTING WAS PERFORMED TO EVALUATE THE PERFORMANCE OF THE REAGENT LOT 69363FP00. AN INTERNAL CA 19-9XR PANEL WAS TESTED WITH RETAINED KITS OF THE LIKELY CAUSE REAGENT LOT. ACCEPTANCE CRITERIA WAS MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ALINITY I CA 19-9XR REAGENT LOT 69363FP00 WAS IDENTIFIED.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21 / 31, WITH 510K/PMA/BLA NUMBER K052000.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I CA 19-9 RESULTS FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) INITIAL RESULT 81.59 U/ML, RETEST 5.58 U/ML AND RETEST ON A DIFFERENT INSTRUMENT 7.04 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.