ELECSYS CA 19-9

Description of Event or Problem

THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CA 19-9 RESULT FROM THE COBAS 8000 E 801 MODULE. THE INITIAL RESULT WAS UNMEASURABLE, THE FIRST REPEAT RESULT AFTER A DILUTION OF 1:2 WAS 629 U/ML, AND THE SECOND REPEAT RESULT AFTER A DILUTION OF 1:10 WAS 942 U/ML. THE SAMPLE WAS SUBMITTED FOR INITIAL INVESTIGATION. ON (B)(6) 2025, THE UNDILUTED RESULT WAS 645 U/ML. THE RESULTS AFTER A 1:2 DILUTION WERE 647 U/ML AND 984 U/ML. THE RESULT AFTER A 1:5 DILUTION WAS 1495 U/ML. THE RESULT AFTER A 1:10 DILUTION WAS 1870 U/ML. ON (B)(6) 2025, THE RESULT FROM A FUJIREBIO LUMIPULSE ASSAY WAS 772 U/ML.

Additional Manufacturer Narrative

THE COBAS 8000 E 801 MODULE SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE CALIBRATION AND QC WERE ACCEPTABLE. THE REPORTED PATIENT SAMPLE WAS PROVIDED FOR FURTHER INVESTIGATION AND WAS TESTED FOR ELECSYS CA 19-9. INVESTIGATION RESULTS: THE FIRST RESULT WAS 667 U/ML. THE SECOND RESULT WAS 986 U/ML (DILUTION FACTOR: 1:5). THE THIRD RESULT WAS 1834 U/ML (DILUTION FACTOR: 1:10). THE INVESTIGATION CONFIRMED THE CUSTOMER'S RESULTS. THE INVESTIGATION NOTED A NON-LINEAR BEHAVIOR IN THE DILUTION RESULTS, CONFIRMING THE PRESENCE OF AN UNKNOWN INTERFERENT IN THE PATIENT SAMPLE. THE INVESTIGATION DETERMINED THAT AN UNKNOWN INTERFERENT HAD CAUSED THE EVENT. A GENERAL REAGENT PRODUCT PROBLEM WAS EXCLUDED.