ELECSYS T4 ASSAY

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF HIGH THYROID RESULTS FOR 1 PATIENT TESTED ON A COBAS E 801 MODULE COMPARED TO THE SIEMENS CENTAUR METHOD. BASED ON THE DATA PROVIDED, DISCREPANT RESULTS WERE IDENTIFIED FOR ELECSYS T4 (T4), ELECSYS T3 (T3), ELECSYS FT3 III (FT3 III) AND ELECSYS FT4 II (FT4 II). THIS MEDWATCH WILL COVER T4. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE T3 RESULTS, MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III RESULTS AND MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 II RESULTS. THE RESULTS FROM THE E801 MODULE WERE REPORTED OUTSIDE OF THE LABORATORY. THE RESULTS FROM THE SIEMENS METHOD WERE BELIEVED TO BE CORRECT. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E801 MODULE SERIAL NUMBER WAS (B)(4).

Additional Manufacturer Narrative

THE CUSTOMER¿S CALIBRATION AND QC DATA WERE ACCEPTABLE. FROM THE INFORMATION AND DATA PROVIDED, A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE DIFFERENCES IN RESULTS AND REFERENCE RANGES FROM T4 ASSAYS BY DIFFERENT MANUFACTURES, IN THIS CASE SIEMENS, CAN VARY DUE TO DIFFERENCES IN THE TYPES OF ANTIBODIES USED, SETUPS OF THE ASSAYS, AND STANDARDIZATION METHODOLOGIES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM AS NO SAMPLE COULD BE PROVIDED FOR INVESTIGATION. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.