ELECSYS FT4 IV

Additional Manufacturer Narrative

THE COBAS PRO SSU SERIAL NUMBER WAS NOT PROVIDED. SAMPLE MATERIAL FROM THE PATIENT WAS REQUESTED FOR FURTHER INVESTIGATION. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE THYROID RESULTS FOR ONE PATIENT FROM THE COBAS PRO SSU. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THIS MEDWATCH IS FOR THE ELECSYS FT4 IV ASSAY. REFER TO THE MEDWATCHS WITH A1 PATIENT IDENTIFIERS (B)(6) FOR THE OTHER INVOLVED ASSAYS.

Additional Manufacturer Narrative

TESTING OF THE PROVIDED PATIENT SAMPLE REVEALED THE PRESENCE OF A STREPTAVIDIN INTERFERING FACTOR, WHICH CAUSED THE FALSELY ELEVATED VALUES. PER PRODUCT LABELING FOR THE ASSAY: 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.