ELECSYS T4

Additional Manufacturer Narrative

THE SAMPLE WAS REQUESTED FOR INVESTIGATION.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS T3 (T3), ELECSYS FT3 (FT3), ELECSYS T4 (T4), ELECSYS FT4 (FT4) AND ELECSYS TSH (TSH) ON A COBAS 8000 E 602 MODULE COMPARED TO THE SIEMENS AND AUTOBIO METHODS. THIS MEDWATCH WILL COVER T4. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE T3 RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TSH RESULTS. REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS. THE ROCHE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THEY WERE QUESTIONED AS THEY DID NOT CORRESPOND TO THE PATIENT¿S CLINICAL PICTURE. THE SAMPLE WAS REPEATED BY 2 OTHER METHODS. THE CUSTOMER SUSPECTS AN INTERFERENCE AFFECTING THE ROCHE RESULTS. THE E602 MODULE SERIAL NUMBER WAS (B)(4).

Additional Manufacturer Narrative

THE REAGENT MATERIAL NUMBER WAS PROVIDED BY THE INVESTIGATION. SECTION D4, CATALOG NUMBER, AND UDI# WERE UPDATED. SECTION G4, 510K WAS UPDATED. THE SAMPLE WAS SUBMITTED FOR INVESTIGATION. THE CUSTOMER'S RESULTS WERE REPRODUCED DURING THE INVESTIGATION. INTERFERENCE TESTING WAS PERFORMED AND NO INTERFERING FACTORS WERE IDENTIFIED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.