ELECSYS CA 19-9

Description of Event or Problem

THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS CA 19-9 RESULT FROM THREE PATIENT SAMPLES TESTED ON THE COBAS 8000 CORE UNIT. PATIENT SAMPLE 1: ON (B)(6) 2025 THE INITIAL RESULT WAS 557 U/ML. ON (B)(6) 2025 THE REPEAT RESULT WAS 885 U/ML. PATIENT SAMPLE 2: ON (B)(6) 2025 THE INITIAL RESULT WAS 414 U/ML. ON (B)(6) 2025 THE REPEAT RESULT WAS 312 U/ML. PATIENT SAMPLE 3: THE INITIAL RESULT WAS 1000 U/ML WITH A DATA FLAG. THE FIRST REPEAT RESULT AT 1:100 DILUTION WAS 223 U/ML. THE SECOND REPEAT RESULT WAS 44.4 U/ML. THE THIRD REPEAT RESULT WAS 44.4 U/ML.

Additional Manufacturer Narrative

THE COBAS 8000 CORE UNIT SERIAL NUMBER IS (B)(6). THE CUSTOMER CONFIRMED THAT THE PATIENT SAMPLE CONTAINED FIBROUS PROTEIN; THIS WAS REMOVED BEFORE THE FOURTH RUN OF PATIENT SAMPLE 3. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE INVESTIGATION INCLUDED A REVIEW OF THE DATA SET PROVIDED BY THE CUSTOMER: THE CALIBRATION RESULTS WERE WITHIN THE SPECIFIED RANGES. THE QC RESULTS WERE WITHIN THE SPECIFIED RANGES. THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO A PREANALYTIC ISSUE (FIBRIN IN THE PATIENT SAMPLE) AT THE CUSTOMER SITE. PREANALYTICS ARE WITHIN THE CUSTOMER'S RESPONSIBILITY. A GENERAL REAGENT PROBLEM WAS NOT DETECTED, AS THE QC BEFORE THE EVENT WAS WITHIN THE EXPECTED RANGES, AND ISOLATED NON-REPRODUCIBLE RESULTS DO NOT REPRESENT A GENERAL MALFUNCTION OF THE ASSAY. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.