T4

Additional Manufacturer Narrative

IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR 5 SAMPLES FROM THE SAME PATIENT TESTED FOR THYROXINE (T4) AND T UPTAKE. THE CUSTOMER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION FOR T UPTAKE. OF THE 5 SAMPLES, 3 WERE FOUND TO HAVE ERRONEOUS RESULTS. ALL INITIAL RESULTS FROM THESE SAMPLES WERE QUESTIONED BY THE PHYSICIAN SINCE THE PATIENT'S THYROID HAD BEEN REMOVED. ALL 3 OF THESE SAMPLES WERE REPEATED AT ANOTHER LABORATORY AND THESE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. IT WAS ASKED, BUT IT IS NOT KNOWN WHAT SPECIFIC METHODOLOGY WAS USED AT THE OTHER LABORATORY. THE CUSTOMER STATED THAT THE OTHER LABORATORY USED AN IMMUNOASSAY METHOD. THE FIRST SAMPLE INITIALLY RESULTED AS 17.6 UG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED FOUR ADDITIONAL TIMES ON (B)(6) 2013 IN ORDER TO VERIFY THE INITIAL REPORTED RESULT AND THE REPEAT RESULTS WERE 17.8 UG/ML, 18.25 UG/ML, 18.02 UG/ML, AND 18.32 UG/ML. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND TESTED ON (B)(6) 2013, WHERE IT RESULTED AS 8.5 UG/ML. THE REPEAT RESULT OF 8.5 UG/ML FROM THE OTHER LABORATORY WAS BELIEVED TO BE CORRECT. A SECOND SAMPLE FROM THE SAME PATIENT WAS INITIALLY TESTED ON (B)(6) 2013 RESULTING AS 17.6 UG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND TESTED, WHERE IT RESULTED AS 7.9 UG/ML. THE REPEAT RESULT OF 7.9 UG/ML FROM THE OTHER LABORATORY WAS BELIEVED TO BE CORRECT. A THIRD SAMPLE FROM THE SAME PATIENT WAS INITIALLY TESTED ON (B)(6) 2014 AND RESULTED AS 21.1 UG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND TESTED, WHERE IT RESULTED AS 9.8 UG/ML. THE REPEAT RESULT OF 9.8 UG/ML FROM THE OTHER LABORATORY WAS BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE SAMPLES WERE INITIALLY TESTED ON E602 ANALYZER, SERIAL NUMBER (B)(4). THE PATIENT'S PHYSICIAN DID INDICATE THAT MANY OF HIS PATIENTS TAKE BIOTIN FOR NAILS AND HAIR, BUT THIS PATIENT DID NOT INDICATE THAT SHE WAS TAKING IT. THE PHYSICIAN ADMITTED THAT THE PATIENT MAY NOT COMMENT ON BIOTIN SUPPLEMENTATION. LABELING FOR THE ASSAY STATES THAT SAMPLES SHOULD NOT BE TAKEN FROM PATIENTS RECEIVING THERAPY WITH HIGH BIOTIN DOSES UNTIL AT LEAST 8 HOURS FOLLOWING THE LAST BIOTIN ADMINISTRATION. THE CUSTOMER DECLINED A SERVICE VISIT AS THE CUSTOMER BELIEVES THE ISSUE TO BE ISOLATED TO ONE PATIENT.

Additional Manufacturer Narrative

A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. FROM THE INFORMATION PROVIDED, A REAGENT ISSUE MOST LIKELY CAN BE EXCLUDED.

Additional Manufacturer Narrative

THE CUSTOMER HAS CLARIFIED THAT THEY HAVE NOT BEEN ABLE TO DETERMINE IF THE SAMPLES SENT TO THE REFERENCE LABORATORY WERE FROM THE SAME SAMPLE DRAWINGS OR TUBES THAT WERE RUN ON THE E602 ANALYZER.

Additional Manufacturer Narrative

IT HAS BEEN CONFIRMED THAT THE CORRECT UNITS OF MEASUREMENT FOR THE T4 ASSAY ARE UG/DL.