ELECSYS CA 19-9

Additional Manufacturer Narrative

THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBERS WERE (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FROM TWO COBAS E 801 ANALYTICAL UNITS. SAMPLE 1 INITIAL RESULT WAS 50.9 IU/ML FROM SERIAL NUMBER (B)(6). THE RESULTS WERE 63.9 IU/ML AND OVER 1000 IU/ML FROM SERIAL NUMBER (B)(6). THE REPEAT RESULT FROM EACH SERIAL NUMBER WAS 18 IU/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS RECENTRIFUGED, AND THE RESULT FROM EACH SERIAL NUMBER WAS 281 IU/ML. ON (B)(6) 2025, SAMPLE 2 INITIAL RESULT FROM SERIAL NUMBER (B)(6) WAS 38.8 IU/ML. THE RESULT FROM SERIAL NUMBER (B)(6) WAS 29 IU/ML. THE THIRD RESULT WAS 28.9 IU/ML, BUT IT WAS NOT KNOWN WHICH ANALYZER GENERATED THIS RESULT.

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER CHECKED THE ANALYZER AND FOUND NO ISSUES. CALIBRATION AND QC DATA WERE ACCEPTABLE. REPEATABILITY, ACCURACY, AND PERFORMANCE OF THE REAGENT WERE FOUND TO BE ACCEPTABLE. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH PRE-ANALYTICAL HANDLING ISSUES AT THE CUSTOMER SITE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. THERE IS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE.