IMMULITE® 2000 CEA

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 2432235-2023-00134 ON JUNE 02, 2023. AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT A FALSELY ELEVATED CEA RESULT THAT WAS OBTAINED ON A SAMPLE FROM ONE PATIENT ON AN IMMULITE 2000 XPI INSTRUMENT AND CONSIDERED DISCORDANT WITH THE LOWER REPEAT RESULT. ON JUNE 04, 2023 ADDITIONAL INFORMATION: SIEMENS INVESTIGATED. THE CUSTOMER PROVIDED THE PATIENT SAMPLE THAT HAD THE NONREPEATABLE ELEVATED RESULT WHEN USING THE IMMULITE 2000 XPI CEA ASSAY FOR FURTHER TESTING. SIEMENS PERFORMED INTERNAL TESTING OF THE SAMPLE WITH THE IMMULITE 2000 XPI CEA KIT LOT 365 ALONG WITH 5 IN HOUSE SERUM NORMAL PATIENT SAMPLES. THE SAMPLE WAS TESTED IN REPLICATES OF 10 AND NONE OF THE SAMPLES TESTED INTERNALLY BY SIEMENS HAD NONREPEATABLE ELEVATED RESULTS. IN SUMMARY, THERE IS NO INDICATION THE ISSUE WITH NONREPEATABLE ELEVATED RESULT IS DUE TO IMMULITE 2000 XPI CEA REAGENTS. THIS TESTING DOES NOT RULE OUT AN INTEGRITY ISSUE WITH THE CUSTOMER'S SAMPLE WHEN ORIGINALLY TESTED BECAUSE THE INTEGRITY OF THE SAMPLE MAY HAVE CHANGED OVER TIME (FIBRIN IN THE SAMPLE MAY HAVE BROKEN DOWN OVER, PARTICULATE MATTER IN THE SAMPLE MAY HAVE SETTLED OUT, ETC.). BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT IS CONSISTENT WITH SAMPLE INTEGRITY ISSUES. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Description of Event or Problem

A FALSELY ELEVATED CEA (CARCINOEMBRYONIC ANTIGEN) RESULT WAS OBTAINED ON SAMPLE FROM ONE PATIENT ON AN IMMULITE 2000 XPI INSTRUMENT AND CONSIDERED DISCORDANT WITH THE LOWER REPEAT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CEA RESULTS.

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT A FALSELY ELEVATED CEA RESULT THAT WAS OBTAINED ON A SAMPLE FROM ONE PATIENT ON AN IMMULITE 2000 XPI INSTRUMENT AND CONSIDERED DISCORDANT WITH THE LOWER REPEAT RESULT. THE IFU STATES IN THE LIMITATIONS SECTION: ¿PATIENTS WITH CONFIRMED CARCINOMA OFTEN HAVE PRETREATMENT CEA LEVELS IN THE SAME RANGE AS HEALTHY PERSONS. ELEVATED CEA LEVELS ARE FREQUENTLY OBSERVED IN SMOKERS, IN CANCER PATIENTS AND IN PATIENTS WITH A VARIETY OF NONMALIGNANT DISEASES AND INFLAMMATORY CONDITIONS. THEREFORE, A SERUM CEA LEVEL, REGARDLESS OF ITS VALUE, SHOULD NOT BE INTERPRETED AS ABSOLUTE EVIDENCE FOR THE PRESENCE OR ABSENCE OF MALIGNANT DISEASE. THE CEA VALUE SHOULD BE USED IN CONJUNCTION WITH INFORMATION AVAILABLE FROM CLINICAL EVALUATION AND OTHER DIAGNOSTIC PROCEDURES. THE IMMULITE 2000 CEA ASSAY SHOULD NOT BE USED AS A CANCER SCREENING TEST.¿ SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING.