ELECSYS CA 19-9

Additional Manufacturer Narrative

THE INVESTIGATION CONFIRMED THE CUSTOMER¿S CA 19-9 RESULT. THE INVESTIGATION CONFIRMED THE PRESENCE OF AN INTERFERENT (HIGH MOLECULAR WEIGHT HETEROPHILIC ANTIBODIES) IN THE PATIENT SAMPLE USING A HETEROPHILIC BLOCKING TUBE (HBT). THE INVESTIGATION DETERMINED THAT THE INTERFERENT (HIGH MOLECULAR WEIGHT HETEROPHILIC ANTIBODIES) HAD CAUSED THE EVENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CA 19-9 ASSAY RESULTS FROM ONE SAMPLE FROM THE SAMPLE PATIENT TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE REPORTER STATED THAT THE PATIENT'S RESULTS FROM (B)(6) 2024 WERE CONSISTENTLY <10 U/ML. THEY NOTICED THE RESULTS STARTED TO INCREASE IN (B)(6) 2024. ON (B)(6) 2024, THE INITIAL RESULT OF THE INITIAL PATIENT SAMPLE WAS 80.5 U/ML. ON (B)(6) 2024, THE REPEAT RESULT WAS 88.4 U/ML. THE PATIENT THEN WENT TO ANOTHER LABORATORY THAT USES A BECKMAN ANALYZER. THE RESULT OF THE PATIENT SAMPLE IN THIS LABORATORY WAS 4.0 IU/ML. THE INITIAL PATIENT SAMPLE WAS ALSO SENT TO ANOTHER LABORATORY FOR VERIFICATION: ON (B)(6) 2024: THE REPEAT RESULT FROM THE DIASORIN ANALYZER WITH CHEMILUMINESCENCE AS THE LABORATORY METHOD WAS 7 U/ML. THE REPEAT RESULT FROM THE VIDAS ANALYZER THAT USES THE ENZYME-LINKED FLUORESCENT ASSAY (ELFA) LABORATORY METHOD WAS 7 U/ML. THE REPORTER COMPLAINED THAT ALL THE COMPETITOR RESULTS WERE IN THE NORMAL RANGE AND ONLY THE RESULTS FROM THE ANALYZER WERE PATHOLOGICAL AND INCREASING.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S COBAS E 801 ANALYTICAL UNIT IS (B)(6). THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION. THE INVESTIGATION REVIEWED THE CALIBRATION DATA AND QC. THE RESULTS WERE WITHIN SPECIFICATIONS. THE INVESTIGATION REVIEWED THE ALARM TRACE. NO ISSUES WERE NOTED. THE INVESTIGATION IS ONGOING.