ELECSYS T4

Description of Event or Problem

THE INITIAL REPORTER QUESTIONED THYROID RESULTS FOR 1 PATIENT TESTED ON A COBAS E801 MODULE COMPARED TO THE BECKMAN, ABBOTT, SIEMENS AND WANTAI METHODS. DISCREPANT RESULTS WERE IDENTIFIED FOR ELECSYS T3 (T3), ELECSYS FT3 (FT3), ELECSYS T4 (T4), ELECSYS FT4 (FT4) AND ELECSYS TSH (TSH). 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 BY THE DOCTOR AS THE PATIENT HAD BEEN TAKING METHIMAZOLE. THE CUSTOMER SUSPECTS AN INTERFERENCE AFFECTING THE ROCHE RESULTS. THE E801 MODULE SERIAL NUMBER WAS (B)(4).

Additional Manufacturer Narrative

THE SAMPLE WAS REQUESTED FOR INVESTIGATION BUT COULD NOT BE PROVIDED. SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.