ELECSYS FSH

Description of Event or Problem

WE RECEIVED AN ALLEGATION OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS ESTRADIOL III ASSAY (ESTRADIOL III) AND ELECSYS FSH (FSH) ON A COBAS 6000 E601 MODULE. THE ESTRADIOL III RESULT FROM THE E601 MODULE WAS 769.20 PMOL/L. THE SAMPLE WAS REPEATED TWICE ON THE E601 MODULE WITH RESULTS OF 800.8 PMOL/L AND 804.6 PMOL/L. THE FSH RESULT FROM THE E601 MODULE WAS 1.31 IU/L. THE DOCTOR QUESTIONED THE ESTRADIOL RESULT AS IT WAS NOT CONSISTENT WITH THE PATIENT¿S CONDITION. THE SAMPLE WAS REPEATED BY A COMPETITOR METHOD, AND THE ESTRADIOL RESULT WAS < 55.1 PMOL/, L AND THE FSH RESULT WAS 1.85 MIU/ML. THIS MEDWATCH WILL COVER FSH. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ESTRADIOL III RESULTS.

Additional Manufacturer Narrative

THE COMPETITOR METHOD WAS (B)(4). THE E601 MODULE SERIAL NUMBER WAS (B)(6). THE SAMPLE WAS REQUESTED FOR INVESTIGATION.

Additional Manufacturer Narrative

CALIBRATION AND QC WERE ACCEPTABLE. THE SAMPLE WAS RECEIVED FOR INVESTIGATION. UPON FURTHER INVESTIGATION OF THE PATIENT SAMPLE, AN INTERFERENT AGAINST THE STREPTAVIDIN COMPONENT OF THE REAGENT WAS CONFIRMED. THIS INTERFERENCE IS COVERED IN 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." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.