ELECSYS AFP

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 4 PATIENTS' SAMPLES TESTED WITH ELECSYS ALPHA-FETOPROTEIN (AFP) ASSAY ON A COBAS PURE E402 ANALYTICAL UNIT. SAMPLE 1: INITIAL RESULT: 11.9 IU/ML. 1ST REPEAT RESULT: 3.04 IU/ML. SAMPLE 2: INITIAL RESULT: 10.3 IU/ML. 1ST REPEAT RESULT: 1.18 IU/ML. SAMPLE 3: INITIAL RESULT: 20.2 IU/ML. 1ST REPEAT RESULT: 182.7 IU/ML. THE PHYSICIAN QUESTIONED THE INITIAL RESULTS FOR SAMPLE 1, SAMPLE 2, AND SAMPLE 3 AS THEY WERE HIGH, AND THE SAMPLES WERE THEN REPEATED FOR THE 1ST TIME ON AN E411). ON (B)(6) 2025, SAMPLE 1, SAMPLE 2, AND SAMPLE 3 WERE REPEATED AFTER REPLACING A NEW REAGENT PACK AND PERFORMING CALIBRATION ON THE E402. SAMPLE 1: 2ND REPEAT RESULT: 3.4 IU/ML (TESTED ON E402). 3RD REPEAT RESULT: 3.94 IU/ML (TESTED ON E411). SAMPLE 2: 2ND REPEAT RESULT: 1.57 IU/ML (TESTED ON E402). 3RD REPEAT RESULT: 1.38 IU/ML (TESTED ON E411). SAMPLE 3: 2ND REPEAT RESULT: 165 IU/ML (TESTED ON E402). 3RD REPEAT RESULT: 184.9 IU/ML (TESTED ON E411). ALSO, ON (B)(6) 2025, SAMPLE 4 WAS INITIALLY TESTED ON E402, RESULTING IN AN AFP VALUE OF 225 IU/ML. THE SAMPLE WAS REPEATED ON AN E411 USING ANOTHER REAGENT LOT NUMBER, AND THE REPEAT RESULT WAS 1.19 IU/ML.

Additional Manufacturer Narrative

THE AFP REAGENT EXPIRATION DATE WAS NOT PROVIDED. SAMPLE 4 WAS REPEATED USING THE AFP REAGENT LOT NUMBER 821474. THE COBAS PURE E402 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE QC WAS WITHIN THE RANGES. THE CALIBRATION WAS PERFORMED ON 20-MAY-2025, AND IT FAILED WITH A DUP.E ALARM. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

DURING TROUBLESHOOTING, THE FIELD SERVICE ENGINEER REPLACED THE SAMPLE PROBE, REAGENT PROBE, MEASURING CELL, AND MICROBEAD MIXER AND PERFORMED THE ADJUSTMENTS. THE TROUBLESHOOTING ACTIONS PERFORMED BY THE ENGINEER RESOLVED THE ISSUE. A GENERAL REAGENT PROBLEM CAN BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.