ELECSYS FSH

Additional Manufacturer Narrative

THE SAMPLE FROM (B)(6) 2024 WAS SUBMITTED FOR INVESTIGATION. THE UNTREATED FSH RESULT WAS 56.6 MIU/ML. AFTER POLYETHYLENE GLYCOL (PEG) TREATMENT, THE FSH RESULT WAS 7.7 MIU/ML. THE SAMPLE WAS INVESTIGATED FURTHER USING SIZE EXCLUSION CHROMATOGRAPHY (SEC). THE INVESTIGATION RESULTS SHOW AN INTERFERENCE IN THE PATIENT SAMPLE CAUSED BY MACRO FSH. PRODUCT LABELING STATES: "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." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

ON 02-DEC-2024 A NEW SAMPLE WAS OBTAINED AND THE FSH RESULT WAS 53.6 IU/L. THIS SAMPLE WAS REQUESTED FOR INVESTIGATION.

Description of Event or Problem

THE INITIAL REPORTER QUESTIONED HIGH RESULTS FOR 1 PATIENT TESTED FOR ELECSYS FSH (FSH) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 53.40 MIU/ML. THE CUSTOMER SUSPECTED AN INTERFERENCE AFFECTING THE RESULT AND PERFORMED A POLYETHYLENE GLYCOL (PEG) PRECIPITATION TEST WITH THE SAMPLE AND THE RESULT WAS 17.0 MIU/L. A NEW SAMPLE WAS OBTAINED AND THE RESULT WAS ALSO "HIGH." THE SPECIFIC RESULT WAS NOT PROVIDED.

Additional Manufacturer Narrative

THE E801 ANALYZER SERIAL NUMBER WAS (B)(6). SAMPLE MATERIAL WAS REQUESTED FOR INVESTIGATION.