ELECSYS CA 19-9

Additional Manufacturer Narrative

THE CA 19-9 REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE E801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE QC WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS CARBOHYDRATE ANTIGEN 19-9 (CA 19-9) ASSAY ON A COBAS E801 ANALYTICAL UNIT. INITIAL RESULT: 51.1 U/ML. THE INITIAL RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS, AND THE SAMPLE WAS REPEATED. 1ST REPEAT RESULT: 11.8 U/ML. 2ND REPEAT RESULT: 11.6 U/ML. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY.

Additional Manufacturer Narrative

SECTION D4 WAS UPDATED. THE CALIBRATION SIGNALS PRIOR TO THE EVENT WERE WITHIN THE EXPECTED RANGE. THE ASSAY PERFORMANCE CHECK WAS LAST PERFORMED ON 03-OCT-2024 WITH SUCCESSFUL RESULTS. ACCORDING TO THE PROVIDED DATA, THE CUSTOMER PERFORMS THE CALIBRATION REGULARLY, AND THE CALIBRATION SIGNALS PRIOR TO THE EVENT WERE WITHIN THE EXPECTED RANGE. A GENERAL REAGENT OR ANALYZER PROBLEM CAN BE EXCLUDED BECAUSE THE QC PRIOR TO THE EVENT WAS WITHIN THE RANGES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.