ELECSYS FT3 III

Additional Manufacturer Narrative

THE SAMPLE WAS RECEIVED FOR INVESTIGATION. THE CUSTOMER'S HIGH FT3 RESULTS WERE REPRODUCED DURING THE INVESTIGATION. UPON FURTHER INVESTIGATION OF THE PATIENT SAMPLE, AN INTERFERENT AGAINST A COMPONENT OF THE REAGENT WAS CONFIRMED. THIS INTERFERENCE CAUSED THE HIGH FT3 RESULTS. 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

CALIBRATION AND QC WERE ACCEPTABLE. INSTRUMENT MAINTENANCE WAS CURRENT. THE SAMPLE WAS REQUESTED FOR INVESTIGATION.

Description of Event or Problem

THE INITIAL REPORTER QUESTIONED THE RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS FT3 III (ELECSYS FT3 III) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULTS FROM THE E801 ANALYZER WERE 8.6 PMOL/L AND 8.64 PMOL/L. THE SAMPLE WAS TESTED BY THE ABBOTT METHOD WITH A RESULT OF 3.76 PMOL/L. ON (B)(6) 2023 THE SAMPLE WAS RESPUN AND REPEATED ON THE E801 ANALYZER WITH A RESULT OF 8.67 PMOL/L NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E801 ANALYZER SERIAL NUMBER WAS (B)(4).