ELECSYS FSH

Additional Manufacturer Narrative

THE SAMPLE FOR PATIENT 2 WAS REPEATED FOR A 2ND TIME FOR FSH ON (B)(6) 2025, AND THE 2ND REPEAT RESULT WAS 4.5 MIU/ML. NO CALIBRATION INFLUENCE WAS OBSERVED. THE PROVIDED QC WAS NOT WITHIN EXPECTATIONS FOR THE DAY OF THE EVENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THE AFP REAGENT LOT NUMBER WAS 821474. THE EXPIRATION DATE WAS NOT PROVIDED. THE COBAS E411 DISK SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS AFP ASSAY AND 1 PATIENT SAMPLE TESTED WITH ELECSYS FSH ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER (DISK SYSTEM). THIS MEDWATCH WILL APPLY TO THE FSH ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE AFP ASSAY. PATIENT 1: AFP: INITIAL RESULT: 0.750 IU/ML (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 51.95 IU/ML. PATIENT 2 WAS TESTED ON (B)(6) 2025: FSH: INITIAL RESULT: 0.300 MIU/ML. REPEAT RESULT: 6.20 MIU/ML.