ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA)

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED ELEVATED ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA) RESULTS, WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING ON ALTERNATE ANALYZERS. 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 EVALUATING THE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA) RESULTS WHEN USING REAGENT LOT#: 222, WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING ON ALTERNATE ANALYZERS. AN INITIAL ELEVATED CEA RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THIS RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED TWICE ON THE ORIGINAL ATELLICA IM ANALYZER, AND THE REPEAT RESULTS RECOVERED LOWER BUT WERE OVER THE REFERENCE RANGE. THE SAME SAMPLE WAS REPROCESSED AGAIN WITH HETEROPHILIC BLOCKING TUBE (HBT) TESTING ON AN ALTERNATE ATELLICA IM ANALYZER (S/N: (B)(6) AND OBTAINED AN ELEVATED RESULT EQUIVALENT TO THE INITIAL ERRONEOUS RESULT. THE SAMPLE WAS THEN REPEATED ON AN ALTERNATE TEST METHOD (ROCHE ANALYZER) AND OBTAINED A LOWER RESULT RECOVERED WITHIN THE REFERENCE RANGE, WHICH WAS CONSIDERED CORRECT, AND ALL THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAMPLE WAS MANUALLY DILUTED FIVE TIMES AND AGAIN TESTED ON AN UNKNOWN ANALYZER, AND THE FIFTH REPEAT RESULT RECOVERED LOWER BUT WAS OVER THE REFERENCE RANGE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

Additional Manufacturer Narrative

SIEMENS FILED INITIAL MDR 1219913-2025-00109 ON 5-JUN-2025. ADDITIONAL INFORMATION (18-JUN-2025): SIEMENS HEALTHCARE DIAGNOSTICS HAS CONCLUDED THE INVESTIGATION OF THE EVENT. AN OUTSIDE UNITED STATES (OUS) CUSTOMER REPORTED AN OBSERVATION OF ELEVATED ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA) RESULTS, WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING. SIEMENS EVALUATED THE INSTRUMENT DATA AND THE INFORMATION PROVIDED BY THE CUSTOMER. REAGENT OBSERVATIONS WERE RULED OUT BASED ON REVIEW OF QC, WHICH SHOWED RECOVERY WITHIN ACCEPTABLE RANGES AND NO ISSUES WERE REPORTED WITH OTHER PATIENT SAMPLES. BASED ON THE LIMITED INFORMATION PROVIDED AND THE UNAVAILABILITY OF SAMPLE, FURTHER EVALUATION IS NOT POSSIBLE, AND THE CAUSE OF THE DISCORDANT RESULT WAS UNABLE TO BE DETERMINED. A PRODUCT PROBLEM HAS NOT BEEN IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE WAS RESOLVED BY ROUTINE TROUBLESHOOTING. NOTE: IN SECTION H6, THE CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED.