T4

Additional Manufacturer Narrative

A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. BASED ON THE INFORMATION PROVIDED, A GENERAL REAGENT ISSUE AT THE CUSTOMER SITE CAN BE EXCLUDED. A POTENTIAL REASON FOR THE DIFFERENCES IN THE T4 RESULTS MAY BE RELATED TO AN INTERFERING FACTOR IN THE SAMPLES THAT AFFECTS THE RESULTS PRODUCED BY THE ASSAYS FROM DIFFERENT MANUFACTURERS.

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT TESTED FOR TRIIODOTHYRONINE (T3), THYROXINE (T4) AND THYROTROPIN (TSH). COMPARISON TESTING WAS BEING PERFORMED BETWEEN AN E411 ANALYZER, AN E601 ANALYZER, AN ABBOTT ARCHITECT METHOD AND THE SIEMENS CENTAUR METHOD. THE TSH RESULTS FROM THE E411 ANALYZER WERE ERRONEOUS AND THE T3, T4 AND TSH RESULTS FROM THE E601 ANALYZER WERE ERRONEOUS. IT IS NOT KNOWN IF ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS INFORMATION HAS BEEN REQUESTED. THIS MEDWATCH WILL COVER THE T4 REAGENT USED WITH THE E601 ANALYZER. (B)(6) FOR INFORMATION ON THE TSH REAGENT USED WITH THE E411 ANALYZER. (B)(6) FOR THE TSH REAGENT USED WITH THE E601 ANALYZER. (B)(6) FOR THE T3 REAGENT USED WITH THE E601 ANALYZER. THE INITIAL TSH RESULT FROM THE E411 ANALYZER WAS 1.84 UIU/ML. THE SAMPLE WAS REPEATED IN ANOTHER LABORATORY ON AN ABBOTT ARCHITECT ANALYZER AND THE RESULT WAS 4.43 UIU/ML. A NEW SAMPLE WAS OBTAINED ON (B)(6) 2016 AND TESTED ON THE ABBOTT ARCHITECT ANALYZER AND THE TSH RESULT WAS 5.23 UIU/ML. THE SAMPLE FROM (B)(6) 2016 WAS REPEATED ON AN E601 ANALYZER AND THE TSH RESULT WAS 1.67 UIU/ML, THE T3 RESULT WAS >651 NG/DL AND THE T4 RESULT WAS >24.86 UG/DL. THE SAMPLE FROM (B)(6) 2016 WAS ALSO REPEATED BY THE SIEMENS-CENTAUR ANALYZER AND THE TSH RESULT WAS 7.72 UIU/ML, THE T3 RESULT WAS 125.1 NG/DL AND THE T4 RESULT WAS 6.5 UG/DL. ADDITIONAL RESULTS FROM A SAMPLE OBTAINED ON (B)(6) 2016 WERE PROVIDED. THE TSH RESULT WAS 5.710 UIU/ML, THE T3 RESULT WAS 112.70 NG/DL AND THE T4 RESULT WAS 6.50 UG/DL. IT IS NOT CLEAR WHAT ANALYZER THESE RESULTS ARE FROM. THIS INFORMATION HAS BEEN REQUESTED. IT IS NOT KNOWN IF AN ADVERSE EVENT OCCURRED. NO ADVERSE EVENT WAS REPORTED. THE E411 ANALYZER SERIAL NUMBER WAS (B)(4). THE E601 ANALYZER SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED.

Additional Manufacturer Narrative

THE T3 RESULT OF >651 NG/DL AND THE T4 RESULT OF >24.86 HAD DATA FLAGS. THESE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE SERIAL NUMBER FOR THE E601 ANALYZER IS (B)(4). THE TSH RESULT OF 5.710 UIU/ML, THE T3 RESULT OF 112.70 NG/DL AND THE T4 RESULT OF 6.50 UG/DL WERE FROM THE (B)(6) 2016 SAMPLE THAT WAS SENT TO A 3RD LABORATORY FOR REPEAT TESTING.