ATELLICA IM CA 19-9

Additional Manufacturer Narrative

SIEMENS FILED INITIAL MDR 1219913-2025-00074 ON 10-APR-2025. ADDITIONAL INFORMATION (30-APR-2025): SIEMENS CONCLUDED INVESTIGATION FOR A CUSTOMER COMPLAINT OF DISCORDANCE BETWEEN THE UNDILUTED AND DILUTED RESULTS OF A PATIENT SAMPLE TESTED WITH THE ATELLICA IM CA 19-9 ASSAY, LOT 537. SIEMENS INVESTIGATED CA 19-9 DILUTION-RECOVERY PERFORMANCE ACROSS MULTIPLE REAGENT LOTS, WHICH INCLUDED BOTH MANUAL AND AUTO 1:10 DILUTIONS WITH MEDICAL DECISION POOL (MDP) LEVEL 5, WHICH IS COMMUTABLE TO PATIENT SAMPLES, HIGH CALIBRATOR LOTS C941H, C943H AND C945H AND HIGH DOSE PATIENT SAMPLES. THE OBSERVED PERFORMANCE MET THE ATELLICA IM DESIGN VERIFICATION REQUIREMENTS, WHICH ALLOW A +/- 30% TOLERANCE FOR AUTO-DILUTION RECOVERY. FURTHER INVESTIGATION DEMONSTRATED THAT THE CA 19-9 ASSAY HAS MET ACCURACY SPECIFICATIONS FOR ALL INTERNAL CONTROL MATERIALS TESTED DURING LOT-QUALIFICATION TESTING OF LOTS RELEASED WITHIN THE PAST TWO YEARS. IT IS NOTED THAT DILUTION-RECOVERY PERFORMANCE IS NOT CONSISTENT ACROSS ALL SAMPLES, AND IT IS POSSIBLE THAT SOME PATIENT SAMPLES MAY EXHIBIT DILUTION OVER-RECOVERY WITH MUCIN/MUCIN-LIKE ASSAYS SUCH AS CA 19-9. THE PRODUCT¿S INSTRUCTIONS FOR USE (IFU) STATES ¿SAMPLE-DEPENDENT NONLINEAR DILUTIONS CAN BE OBSERVED.¿ [REFERENCE: WILD D, ED. THE IMMUNOASSAY HANDBOOK. 4TH ED. OXFORD, UK: ELSEVIER SCIENCE; 2013:842] ADDITIONALLY, IT IS IMPORTANT TO NOTE THAT THE ATELLICA IM CA19-9 IFU STATES THAT THE ASSAY IS USEFUL AS AN AID IN MONITORING THE STATUS OF PATIENTS HAVING CONFIRMED PANCREATIC CANCER WHO HAVE LEVELS OF SERUM AT SOME POINT EXCEEDING THE MEDIAN CONCENTRATION. THE ASSAY IS NOT INTENDED FOR SCREENING PURPOSES AND SHOULD ALWAYS BE USED IN CONJUNCTION WITH ALL OTHER CLINICAL AND LABORATORY DATA. THE ASSAY PROVIDES RESULTS FROM 1.20 ¿ 700 U/ML. ONLY SAMPLES WITH LEVELS >700 U/ML SHOULD BE DILUTED BEFORE RE-TESTING. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT PROBLEM WAS IDENTIFIED, AND NO FURTHER INVESTIGATION IS REQUIRED. IN SECTION H6 OF THIS REPORT, THE INVESTIGATION FINDING, AND CONCLUSION CODES WERE UPDATED BASED ON THE INVESTIGATION RESULTS.

Additional Manufacturer Narrative

A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED AN OBSERVATION OF A DIFFERENCE IN RESULT BETWEEN UNDILUTED AND DILUTED RESULT WHEN A CANCER PATIENT WAS TESTED WITH ATELLICA IM CA 19-9 ANALYZER. IT IS UNKNOWN WHICH RESULT WAS REPORTED TO THE PHYSICIAN(S) OR IF THE RESULT WAS QUESTIONED BY THE PHYSICIAN(S). THE ASSAY'S INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING UNDER INTERPRETATION OF RESULTS: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." SIEMENS IS INVESTIGATING THE ISSUE.

Description of Event or Problem

A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED AN OBSERVATION OF A DIFFERENCE IN RESULTS BETWEEN UNDILUTED AND DILUTED RESULTS WHEN A CANCER PATIENT WAS TESTED WITH ATELLICA IM CA 19-9 ANALYZER. THE CUSTOMER OBTAINED RESULT WITHIN THE ASSAY ANALYTICAL MEASURING RANGE (AMR) BUT RETESTED THE SAMPLE USING A 1:10 DILUTION. THE DILUTED RESULT WAS HIGHER THAN THE UNDILUTED (NEAT) RESULT. IT IS UNKNOWN WHICH RESULT WAS REPORTED TO PHYSICIAN(S) OR IF THE RESULT WAS QUESTIONED BY THE PHYSICIAN(S). THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.