ATELLICA IM CA 19-9

Additional Manufacturer Narrative

SIEMENS INVESTIGATED AN OUTSIDE THE UNITED STATES (OUS) CUSTOMER REPORT OF A DISCORDANT DEPRESSED RESULT ON A PATIENT SAMPLE WHEN USING ATELLICA IM CA 19-9 LOT 539. THE SAMPLE (ID (B)(6)) INITIALLY RECOVERED 648 U/ML AND WHEN RETESTED WITH THE SAME REAGENT PACK AND CALIBRATION AS THE INITIAL RESULT IT RECOVERED > 700 U/ML AND 1,618 U/ML AND 1,635 U/ML WHEN AUTODILUTED (1/10). QUALITY CONTROL (QC) RECOVERY BEFORE AND AFTER THE SAMPLE WAS INITIALLY TESTED DOES NOT INDICATE A BIAS ISSUE, HOWEVER THE HIGHEST CONTROL USED BY THE CUSTOMER RECOVERS APPROXIMATELY 76 U/ML. SIEMENS REVIEWED INSTRUMENT SAMPLE AND REAGENT PROBE TRACE FILES AND THERE IS NO INDICATION THE PROBES LED TO THE INITIAL LOW CA 19-9 RESULT. AUTOCHECK DATA WAS REVIEWED AND A SECONDARY VACUUM ON 08-DEC-2025. CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE ACCOUNT AND PERFORMED ROUTINE INSTRUMENT WHICH INCLUDED CLEANING THE ASPIRATE PINCH VALVE TUBING. AS STATED IN THE DILUTION RECOVERY SECTION OF THE ATELLICA IM CA 19-9 INSTRUCTIONS FOR USE (IFU), "SAMPLE-DEPENDENT NONLINEAR DILUTIONS CAN BE OBSERVED.", WHICH COULD EXPLAIN THE DILUTED RESULTS >1,600 U/ML. GIVEN THE PRECISION OF THE CA 19-9 ASSAY, IT IS POSSIBLE THAT NORMAL VARIATION LED TO THE SAMPLE RECOVERING WITHIN THE MEASURING INTERVAL (1.20 ¿ 700 U/ML). RETURN OF THE PATIENT SAMPLE FOR FURTHER INVESTIGATION IS NOT WARRANTED BECAUSE THE DISCORDANT RESULT WAS NOT REPRODUCIBLE. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT IS INCONCLUSIVE. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE IS RESOLVED BY STANDARD TROUBLESHOOTING AND SERVICE ACTIONS. SIEMENS FILED INITIAL MDR 1219913-2025-00019 ON 15-JAN-2025. IN SECTION H6 OF THIS REPORT, THE INVESTIGATION FINDING AND CONCLUSION CODES WERE UPDATED BASED ON THE INVESTIGATION RESULTS.

Additional Manufacturer Narrative

THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES (OUS). THE OUS CUSTOMER REPORTED AN OBSERVATION OF A DISCORDANT PATIENT RESULT WITH THE ATELLICA IM CA 19-9 ASSAY, LOT 539. THE PATIENT IS A FEMALE CANCER PATIENT UNDERGOING CHEMOTHERAPY. THE INITIAL RESULT (647.79 U/ML) WAS QUESTIONED BY THE PATIENT AND NOT BY THE PHYSICIAN. ALSO, THE PATIENT WENT TO A DIFFERENT LABORATORY FOR CA 19-9 TESTING. AS A RESULT, THE SAME PATIENT SAMPLE WAS REPEATED AND OBTAINED >700 U/ML AND 1635.27 U/ML WITH AUTO DILUTION. THIS RESULT WAS CONSIDERED CORRECT BY THE PATIENT. SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE SITE. 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.

Description of Event or Problem

CUSTOMER REPORTED AN OBSERVATION OF A DISCORDANT PATIENT RESULT WITH THE ATELLICA IM CA 19-9 ASSAY, LOT 539. THE PATIENT IS A FEMALE CANCER PATIENT UNDERGOING CHEMOTHERAPY. THE INITIAL RESULT (647.79 U/ML) WAS QUESTIONED BY THE PATIENT AND NOT BY THE PHYSICIAN. ALSO, THE PATIENT WENT TO A DIFFERENT LABORATORY FOR CA 19-9 TESTING. AS A RESULT, THE SAME PATIENT SAMPLE WAS REPEATED AND OBTAINED >700 U/ML AND 1635.27 U/ML WITH AUTO DILUTION. THIS RESULT WAS CONSIDERED CORRECT BY THE PATIENT. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.