ELECSYS CEA

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT THE EVENT WAS CONSISTENT WITH A PREANALYTICAL HANDLING ISSUE BY THE CUSTOMER. THE SAMPLE SHOWED SIGNS OF HEMOLYSIS, AND THE VOLUME EXCEEDED THE RECOMMENDED FILL CAPACITY OF THE SAMPLE TUBE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. A GENERAL REAGENT OR ANALYZER PROBLEM WAS NOT PRESENT BECAUSE THE CALIBRATION AND QC PRIOR TO THE EVENT WERE WITHIN RANGES. THERE WAS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE.

Additional Manufacturer Narrative

THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CEA RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 13.2 NG/ML. THE CUSTOMER COMPARED THIS RESULT WITH THE CLINICAL FINDINGS AND FOUND IT INCONSISTENT. THIS WAS A CHECK-UP SAMPLE, AND THE PATIENT PRESENTED NO SIGNS OR SYMPTOMS SUGGESTIVE OF CANCER. THEREFORE, THE CUSTOMER REPEATED THE SAMPLE ON (B)(6) 2025, AND THE RESULT WAS 2.43 NG/ML. THE SAMPLE WAS RETESTED ON AN ABBOTT INSTRUMENT, AND THE RESULTS WERE 2.36 AND 2.2 NG/ML. ON (B)(6) 2025, ANOTHER TUBE FROM THE SAME (B)(6) 2025 VENIPUNCTURE WAS TESTED, AND THE RESULT WAS 2.44 NG/ML. THE RESULT OF 2.43 NG/ML WAS BELIEVED TO BE CORRECT AND WAS REPORTED.