ELECSYS CA 19-9

Additional Manufacturer Narrative

THE E801 ANALYZER SERIAL NUMBER WAS (B)(6). THE SAMPLE WAS REQUESTED FOR INVESTIGATION.

Description of Event or Problem

THE INITIAL REPORTER QUESTIONED HIGH RESULTS NOT CORRESPONDING TO THE CLINICAL CONDITION FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CA 19-9 (CA 19-9) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT FROM THE E801 ANALYZER WAS 139 U/ML. THE REPEAT RESULT WAS 143 U/ML. ON (B)(6) 2025, A NEW SAMPLE WAS OBTAINED, AND THE RESULT AT ANOTHER LABORATORY USING THE ABBOTT METHOD WAS 25.7 U/ML. ON (B)(6) 2025, THE ORIGINAL SAMPLE WAS REPEATED ON THE E801 ANALYZER, AND THE RESULT WAS 135 U/ML. THE CUSTOMER SENT THE SAMPLE TO A RESEARCH LABORATORY, WHERE THE RESULT WAS 129.0 U/ML. THE HIGH RESULTS ARE IN QUESTION AS THE PATIENT NORMALLY HAS RESULTS OF APPROXIMATELY 25 U/ML WHEN TESTED AT OTHER LABORATORIES. THE CUSTOMER SUSPECTS AN INTERFERENCE.

Additional Manufacturer Narrative

CALIBRATION AND QC WERE ACCEPTABLE. THE SAMPLE WAS RECEIVED FOR INVESTIGATION; HOWEVER, AN INVESTIGATION WAS NOT POSSIBLE DUE TO THE CONDITION OF THE SAMPLE UPON ARRIVAL. AS THE SAMPLE COULD NOT BE INVESTIGATED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.