ELECSYS T3

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE E411 ANALYZER IS 1914-12. THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION, BUT IT WAS NO LONGER AVAILABLE. FURTHER INVESTIGATION WAS NOT POSSIBLE. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TSH, ELECSYS T3, ELECSYS T4, AND ELECSYS VITAMIN D TOTAL III ON A COBAS E411 DISK. THE RESULTS DID NOT AGREE WITH VALUES MEASURED USING THE ABBOTT ALINITY METHODS. THIS MEDWATCH WILL APPLY TO THE T3 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER PT-0071068 FOR INFORMATION RELATED TO THE TSH ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER PT-0071070 FOR INFORMATION RELATED TO THE T4 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER PT-0071071 FOR INFORMATION RELATED TO THE VITAMIN D ASSAY. THE PATIENT SAMPLE RESULTED IN THE FOLLOWING VALUES WHEN TESTED ON THE E411 ANALYZER: TSH = < 0.005 UIU/ML WITH A DATA FLAG. T3 = > 651.0 NG/DL WITH A DATA FLAG. T4 = > 24.86 UG/DL WITH A DATA FLAG. VITAMIN D = > 120.0 NG/ML WITH A DATA FLAG. THE PATIENT SAMPLE RESULTED IN THE FOLLOWING VALUES WHEN TESTED ON THE ABBOTT ALINITY ANALYZER ON 19-AUG-2024: TSH = 1.809 MIU/L (REFERENCE RANGE = 0.35 - 4.94 MIU/L). T3 = 1.19 NG/ML (REFERENCE RANGE = 0.70 - 2.04 MG/ML). T4 = 10.22 UG/DL (REFERENCE RANGE = 4.60 - 10.50 UG/DL). VITAMIN D = 15.1 NG/ML (SUFFICIENCY = > 30 NG/ML).