IMMULITE® 2000 CEA

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT FALSELY ELEVATED CEA RESULTS THAT WERE OBTAINED ON SAMPLES FROM TWO PATIENTS ON AN IMMULITE 2000 XPI INSTRUMENT AND CONSIDERED DISCORDANT WITH THE LOWER REPEAT RESULTS. 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.

Description of Event or Problem

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

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 2432235-2023-00133 ON (B)(6) 2023. AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT FALSELY ELEVATED CEA RESULTS THAT WERE OBTAINED ON SAMPLES FROM TWO PATIENTS ON AN IMMULITE 2000 XPI INSTRUMENT AND CONSIDERED DISCORDANT WITH THE LOWER REPEAT RESULTS. JUNE 04, 2023 ADDITIONAL INFORMATION: SIEMENS INVESTIGATED. THE CUSTOMER PROVIDED THE 2 PATIENT SAMPLES THAT HAD NONREPEATABLE ELEVATED RESULTS WHEN USING THE IMMULITE 2000 XPI CEA ASSAY FOR FURTHER TESTING. SIEMENS PERFORMED INTERNAL TESTING OF THESE SAMPLES WITH THE IMMULITE 2000 XPI CEA KIT LOT 365 ALONG WITH 5 IN HOUSE SERUM NORMAL PATIENT SAMPLES. EACH 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 RESULTS IS DUE TO IMMULITE 2000 XPI CEA REAGENTS. THIS TESTING DOES NOT RULE OUT AN INTEGRITY ISSUE WITH THE CUSTOMER'S SAMPLES WHEN THEY WERE ORIGINALLY TESTED BECAUSE THE INTEGRITY OF THE SAMPLES 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 RESULTS IS CONSISTENT WITH SAMPLE INTEGRITY ISSUES. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDING AND INVESTIGATION CONCLUSION CODES WERE UPDATED.