ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA)

Additional Manufacturer Narrative

MDR 1219913-2025-00004 WAS INITIALLY FILED ON 07-JAN-2025. ADDITIONAL INFORMATION (04-FEB-2025): A CUSTOMER FROM OUTSIDE THE UNITED STATES (OUS) REPORTED OBSERVATION OF AN ELEVATED ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. SIEMENS EVALUATED THE INSTRUMENT DATA AND THE INFORMATION PROVIDED BY THE CUSTOMER. REAGENT ISSUES WERE RULED OUT BASED ON THE REVIEW OF QUALITY CONTROL (QC) WHICH SHOWED RECOVERY WITHIN ACCEPTABLE RANGES AND NO ISSUES WERE REPORTED WITH OTHER PATIENT SAMPLES. RETURN OF THE PATIENT SAMPLE FOR FURTHER INVESTIGATION IS NOT WARRANTED BECAUSE THE DISCORDANT RESULT WAS NOT REPRODUCIBLE. BASED ON THE AVAILABLE INFORMATION, A SPECIFIC CAUSE FOR THE DISCORDANT RESULTS WAS UNABLE TO BE DETERMINED. A PRODUCT PROBLEM HAS NOT BEEN IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND NO FURTHER ACTIONS ARE REQUIRED. NOTE: IN SECTION H6, CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED.

Additional Manufacturer Narrative

A CUSTOMER FROM OUTSIDE THE UNITED STATES (OUS) REPORTED OBSERVATION OF AN ELEVATED ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. THE CUSTOMER CONFIRMED THAT THE CALIBRATION AND QUALITY CONTROLS (QC) WERE WITHIN RANGES ON THE DAY OF EVENT. 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

THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA) RESULT WHEN USING REAGENT LOT# 221 WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. AN INITIAL ELEVATED RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION. THE INITIAL ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED TWICE ON THE ORIGINAL ATELLICA IM ANALYZER, PRODUCING LOWER RESULTS. THESE LOWER RESULTS WERE CONSIDERED CORRECT, AND THE FIRST REPEAT RESULT WAS REPORTED TO THE PHYSICIAN. IT IS UNKNOWN IF THERE WAS A PRIOR CANCER DIAGNOSIS WITH THE AFFECTED PATIENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.