ELECSYS FSH ASSAY

Additional Manufacturer Narrative

A SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION. THE SAMPLE DID NOT CONTAIN ANY INTERFERING FACTORS AGAINST THE ASSAY STREPTAVIDIN COMPONENT, THE ASSAY RUTHENIUM LABEL, THE IMMUNOGLOBULIN CONCENTRATION, OR HETEROPHILIC ANTIBODIES. BASED ON INVESTIGATIONS OF THE SAMPLE PERFORMED WITH SIZE EXCLUSION CHROMATOGRAPHY, IT WAS DETERMINED THAT THE SAMPLE CONTAINS MACROFSH AND IGG INTERFERENCE. THIS LIMITATION IS COVERED IN PRODUCT LABELING. PER PRODUCT LABELING, "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN.". FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S E411 ANALYZER IS (B)(6). THE SERIAL NUMBER OF THE E411 ANALYZER USED FOR INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FSH ON TWO COBAS E411 ANALYZERS. THE SAMPLE WAS COLLECTED FROM THE PATIENT ON (B)(6) 2024 AND RESULTED IN AN FSH VALUE OF 119.4 MIU/ML WHEN TESTED ON THE CUSTOMER'S E411 ANALYZER. THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING WITH AN UNKNOWN CLIA METHOD, RESULTING IN AN FSH VALUE OF 54.05 MIU/ML. THE SAMPLE WAS PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED USING A SECOND E411 ANALYZER ON (B)(6) 2024, RESULTING IN AN FSH VALUE OF 104.3 MIU/ML. THE SAMPLE WAS ALSO REPEATED USING THE ABBOTT ARCHITECT ASSAY, RESULTING IN AN FSH VALUE OF 44.00 MIU/ML.