T4

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR THYROTROPIN (TSH), TRIIODOTHYRONINE (T3), AND THYROXINE (T4). THE CUSTOMER STATES THAT THE PATIENT HAS HAD QUESTIONABLY HIGH T3 AND T4 TEST RESULTS SINCE THE BEGINNING OF (B)(6) 2013. THIS MEDWATCH WILL COVER T4. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO T3 AND REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO TSH. A SAMPLE FROM (B)(6) 2015 WAS INITIALLY TESTED AT THE CUSTOMER SITE, "MGH", ON AN E601 ANALYZER. THE RESULTS FROM THE E601 ANALYZER WERE REPORTED TO THE PHYSICIAN, WHO DID NOT BELIEVE THE RESULTS. THE RESULTS DID NOT MATCH THE PATIENT'S CLINICAL PRESENTATION, SO THE SAMPLE WAS SENT TO A REFERENCE LABORATORY FOR ADDITIONAL TESTING. THE SAMPLE WAS THEN TESTED AT THE REFERENCE LABORATORY, "SRH", ON AN ABBOTT ARCHITECT ANALYZER. THE RESULTS FROM THE ABBOTT ARCHITECT ANALYZER WERE BELIEVED TO BE CORRECT. REFER TO THE ATTACHMENT FOR THE SAMPLE RESULTS. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE E601 ANALYZER SERIAL NUMBER WAS (B)(4). THE CUSTOMER DECLINED A SERVICE VISIT AND BELIEVED THE ISSUE TO BE PATIENT SPECIFIC. THE CUSTOMER ALLEGED THE ERRONEOUS RESULTS WERE DUE TO INTERFERENCE BY EXOGENOUS BIOTIN TAKEN BY THE PATIENT. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATIONS, BUT COULD NOT BE PROVIDED.