ELECSYS T4 ASSAY

Additional Manufacturer Narrative

A SAMPLE WAS PROVIDED FOR INVESTIGATION. DUE TO LOW SAMPLE VOLUME (~200 UL) ONLY LIMITED TESTING COULD BE PERFORMED. THE RESULTS OF THE TESTING ARE CONSISTENT WITH AN ANTIBODY AGAINST A COMPONENT OF THE REAGENT. THIS INTERRING FACTOR IS ADDRESSED IN THE PRODUCT LABELING.

Additional Manufacturer Narrative

ANOTHER ALIQUOT OF THE PATIENT SAMPLE WAS PROVIDED FOR FURTHER INVESTIGATION. THE RESULTS OBTAINED BY THE CUSTOMER WERE REPRODUCED. AN INTERFERENT AGAINST A COMPONENT OF THE REAGENT WAS CONFIRMED. THIS INTERFERENCE IS COVERED IN PRODUCT LABELING. FROM THE INFORMATION AND DATA PROVIDED, A GENERAL REAGENT ISSUE MOST LIKELY CAN BE EXCLUDED.

Additional Manufacturer Narrative

THE EVENT OCCURRED IN: (B)(6).

Description of Event or Problem

THE CUSTOMER COMPLAINED OF QUESTIONABLE RESULTS FOR MULTIPLE TESTS FOR 1 PATIENT TESTED ON A COBAS 8000 E 801 MODULE COMPARED TO AN ADVIA CENTAURO. FROM THE DATA PROVIDED, A REPORTABLE MALFUNCTION WAS PROVIDED FOR ELECSYS FT3 III, ELECSYS PROLACTIN ASSAY, ELECSYS T3, ELECSYS T4 ASSAY, ELECSYS TESTOSTERONE II ASSAY, AND ELECSYS ESTRADIOL III ASSAY. THE CUSTOMER SUSPECT THERE IS AN INTERFERENCE AFFECTING THE PATIENT SAMPLE. THIS MEDWATCH WILL COVER THE T4 ASSAY. PLEASE REFER TO THE FOLLOWING MEDWATCHES WITH THE FOLLOWING PATIENT IDENTIFIERS FOR INFORMATION RELATED TO EACH OTHER AFFECTED ASSAY: (B)(6). THE DISCREPANT RESULTS ARE HIGHLIGHTED. IT WAS UNKNOWN IF THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE INVESTIGATION IS CURRENTLY ONGOING.