ACCESS® FREE T4 ASSAY

Additional Manufacturer Narrative

CUSTOMER DID NOT CONTACT BEC TO EXPRESS CONCERN. INFORMATION REGARDING THIS EVENT IS OBTAINED FROM (B)(4). ATTEMPT TO FOLLOW UP WITH CUSTOMER HAS BEEN MADE AND THEY STATED THAT THERE HAD BEEN NO ADDITIONAL TESTING PERFORMED. NO INTERFERENCE IS SUSPECTED AS IT WOULD HAVE BEEN PRESENT ON THE SUBSEQUENT REDRAW. THE INITIAL SAMPLE HAD BEEN TOSSED BY THE TIME THE DISCREPANCY WAS NOTED. NO ROOT CAUSE IS DETERMINED WITH INFORMATION SUPPLIED. BEC REP SPOKE WITH (B)(6) WHEN CONTACTED THE ACCOUNT IN ATTEMPT TO INVESTIGATE THE EVENT. AN MDR NUMBER: 2122870-2011-02198 HAS BEEN SUBMITTED FOR TSH.

Description of Event or Problem

A CUSTOMER POSTED THYROID-STIMULATING HORMONE (TSH) AND FREE T4 (FRT4) RESULTS FROM ONE PATIENT, DRAWN 5 DAYS APART TO THE (B)(4) WEBSITE. ON DAY ONE (1), THE FRT4 RESULT IS NORMAL. ON DAY FIVE (5), THE FRT4 RESULT IS ABOVE THE REFERENCE RANGE. UPON FOLLOW UP, THE CUSTOMER DID NOT FEEL THAT FURTHER INVESTIGATION WAS WARRANTED. IT IS UNKNOWN IF THERE WAS ANY CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.