ELECSYS CEA

Additional Manufacturer Narrative

THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE CALIBRATION WAS SLIGHTLY BELOW THE EXPECTED VALUES. THE QC WAS WITHIN RANGE. A GENERAL REAGENT ISSUE WAS EXCLUDED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CEA RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 E 801 MODULE. THE INITIAL RESULT WAS 2.65 NG/ML. ON (B)(6) 2025, THE REPEATED RESULT WAS 6.42 NG/ML. ON (B)(6) 2025, THE REPEATED RESULT WAS 6.49 NG/ML.

Additional Manufacturer Narrative

A DIFFERENT SAMPLE FROM THE SAME PATIENT PRODUCED A RESULT OF 6.85 NG/ML. THIS RESULT CORRELATED WITH THE REPEATED RESULTS OF THE FIRST SAMPLE. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT AS THEY CORRELATED WITH THE PATIENT'S CLINICAL HISTORY. IT WAS NOTED THAT THE GEAR PUMP HEAD WAS OVERDUE FOR REPLACEMENT. IT WAS ALSO NOTED THAT THE SAMPLE HAD A REMNANT OF A PARTICLE, WHICH IS INDICATIVE OF POSSIBLE POOR SAMPLE QUALITY. DUE TO THE LACK OF INFORMATION PROVIDED, THE INVESTIGATION COULD NOT DETERMINE A CLEAR ROOT CAUSE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.