ELECSYS T4

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS FT4 III (FT4 III) AND ELECSYS T4 (T4) ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO THE ABBOTT METHOD. THIS MEDWATCH WILL COVER T4. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 III RESULTS. ON (B)(6) 2021 THE PATIENT STARTED TAKING "LEFT THYROID SODIUM" TABLETS; 1.5 TABLETS PER DAY FOR 90 DAYS. ON (B)(6) 2022 THYROID TESTING WAS PERFORMED ON THE E801 MODULE AND THE PATIENT¿S MEDICATION WAS REDUCED FOR ONE MONTH. ON (B)(6) 2022 THYROID TESTING WAS PERFORMED AGAIN ON THE E801 MODULE AND THE RESULTS WERE NOT AS EXPECTED. THE FT4 RESULT HAD BEEN HIGH WHEN TESTING WAS PERFORMED ON (B)(6) 2022 AND IT WAS STILL HIGH ON (B)(6) 2022. THE SAMPLE WAS REPEATED BY THE ABBOTT METHOD WHERE DISCREPANT RESULTS WERE RECEIVED FOR FT4 AND T4. THE QUESTIONABLE RESULTS FROM (B)(6) 2022 WERE NOT REPORTED OUTSIDE OF THE LABORATORY. REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS FROM (B)(6) 2022 AND (B)(6) 2022. THE E801 MODULE SERIAL NUMBER WAS (B)(4).

Additional Manufacturer Narrative

THE SAMPLE WAS REQUESTED FOR INVESTIGATION HOWEVER, THERE IS NO SAMPLE MATERIAL REMAINING FOR INVESTIGATION. AS NO SAMPLE MATERIAL WAS AVAILABLE FOR FURTHER INVESTIGATION, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.