ELECSYS T4 ASSAY

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6). SAMPLE MATERIAL WAS REQUESTED FOR INVESTIGATION BUT COULD NOT BE PROVIDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Description of Event or Problem

THE INITIAL REPORTER QUESTIONED THYROID RESULTS FOR 1 PATIENT TESTED FOR ELECSYS FT3 III (FT3 III), ELECSYS T3 (T3), ELECSYS T4 (T4) AND ELECSYS ANTI-TPO (ANTI-TPO) ON A COBAS E801 MODULE, A COBAS E 411 IMMUNOASSAY ANALYZER, A COBAS 8000 E 602 MODULE AND A COBAS 6000 E 601 MODULE COMPARED TO THE CENTAUR METHOD. THIS MEDWATCH WILL COVER T4. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE T3 RESULTS, AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ANTI-TPO RESULTS. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER SUSPECTS AN INTERFERENCE AFFECTING THE ROCHE RESULTS. THE CENTAUR RESULTS WERE BELIEVED TO BE CORRECT. REFER TO DATA FOR THE PATIENT RESULTS AND INTERFERENCE TESTING PERFORMED BY THE CUSTOMER. THE COBAS 8000 SYSTEM CORE UNIT SERIAL NUMBER WAS (B)(4). NO OTHER SERIAL NUMBERS WERE PROVIDED.