ALINITY I CA 19-9XR REAGENT KIT
Received May 30, 2025 · Event occurred May 13, 2025
Report 3002809144-2025-00171 · MDR key 22114337
Device
Generic name
System, Test, Carbohydrate Ag (ca19-9), For Monit And Mgmt Of Pancreatic Cancer
Manufacturer
Abbott GmbhCatalog number
08P32-20
Lot number
71457FP00
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
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 08P32-30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21 / 31, WITH 510K/PMA/BLA NUMBER K052000. A1 PATIENT IDENTIFIER: COMPLETE SAMPLE ID IS (B)(6). 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 IMPRECISE ALINITY I CA 19-9XR AND PROVIDED THE FOLLOWING DATA: THE INITIAL RESULT WAS 154 U/ML AND REPEAT IN AUTOMATIC DILUTION 1/10 WAS 700 IU/ML. THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL DATA: ON (B)(6) 2025, SAMPLE ID (B)(6) GENERATED THE FOLLOWING RESULTS 167.31 UNDILUTED, 786.06 1:10 DILUTION, 154.00 UNDILUTED, 1060.21 1:10 DILUTION. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Description of Event or Problem
THE CUSTOMER REPORTED IMPRECISE ALINITY I CA 19-9XR AND PROVIDED THE FOLLOWING DATA: THE INITIAL RESULT WAS 154 U/ML AND REPEAT IN AUTOMATIC DILUTION 1/10 WAS 700 IU/ML. THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL DATA: ON (B)(6) 2025, SAMPLE ID (B)(6) GENERATED THE FOLLOWING RESULTS: 167.31 UNDILUTED, 786.06 1:10 DILUTION, 154.00 UNDILUTED, 1060.21 1:10 DILUTION. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Additional Manufacturer Narrative
THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. DEVICE HISTORY REVIEW FOR THE COMPLAINT LOT DID NOT IDENTIFY ANY ISSUES. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I CA 19-9XR REAGENT AND COMPLAINT LOT DID NOT IDENTIFY AN INCREASE IN COMPLAINTS FOR THE COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF THE ALINITY I CA 19-9XR REVIEWED USING FIELD DATA FROM CUSTOMERS. THE REVIEW OF FIELD DATA DETERMINED THE MEDIAN PATIENT RESULTS FOR LOT 71457FP00 WITHIN THE ESTABLISHED LIMITS AND NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I CA 19-9XR REAGENT LOT 71457FP00.