ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA)

Additional Manufacturer Narrative

A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF AN ELEVATED ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. MDR 1219913-2025-00067 WAS INITIALLY SUBMITTED ON 01-APR-2025. UPDATE, 13-MAY-2025: SIEMENS HAS CONCLUDED THE INVESTIGATION. GENERAL REAGENT ISSUES WERE RULED OUT AS QUALITY CONTROL (QC) RESULTS WERE WITHIN EXPECTED RANGES AND NO ISSUES WERE IDENTIFIED FOR ANY OTHER SAMPLES. BASED ON SIEMENS REVIEW OF INSTRUMENT LOG DETAILS, SAMPLE-PROBE ALIGNMENT WAS PERFORMED ACCORDING TO STANDARD SERVICE GUIDELINES. FOLLOWING INSTRUMENT SERVICE, THE SYSTEM WAS CHECKED AND NO MORE ISSUES WERE OBSERVED. ALTHOUGH A SPECIFIC CAUSE FOR THE DISCORDANT RESULT WAS NOT IDENTIFIED, NO SYSTEMIC PRODUCT PROBLEMS WERE IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE IS RESOLVED BY ROUTINE SERVICE ACTIVITIES. NOTE: IN SECTION H6, THE CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED.

Additional Manufacturer Narrative

A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF AN ELEVATED ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING CEA LOT 223. REPEAT TESTING PRODUCED ACCEPTABLE RESULTS. QUALITY CONTROL (QC) RESULTS ON THE DAY OF THE EVENT WERE WITHIN EXPECTED RANGES. SIEMENS IS INVESTIGATING.

Description of Event or Problem

THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING CEA LOT 223. AN INITIAL ATELLICA IM CEA RESULT DISAGREED WITH LOWER RESULTS OBTAINED IN REPEAT TESTING USING BOTH THE INITIAL INSTRUMENT AND AN ALTERNATE ATELLICA IM ANALYZER. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE DISCORDANT OBSERVATION.