ARCHITECT FREE T4
Received Apr 16, 2026 · Event occurred Mar 30, 2026
Report 3005094123-2026-00181 · MDR key 24903853
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07K65-77
Lot number
80039UD02
Product problems
- High Test Results
Patient
77 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 (FT4) AND ARCHITECT TSH RESULTS FOR A 77-YEAR-OLD MALE PATIENT WITH MYELODYSPLASTIC SYNDROME. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE FOR FT4 IS 9.01-19.05 PMOL/L, FOR TSH IS 0.35-4.94 UIU/ML): SAMPLE ID: (B)(6) INITIAL FT4 RESULT WAS >64.35, REPEAT RESULT WAS 40.28, REPEAT RESULT, AFTER SAMPLE SAT FOR 1 HOUR, WAS 30.67, REPEAT RESULT, THE NEXT DAY, WAS 18.92 PMOL/L; INITIAL TSH RESULT WAS 5.8362, REPEAT RESULT WAS 4.2723, REPEAT RESULT, THE NEXT DAY, WAS 2.9181 UIU/ML. THE PATIENT HAD A PLASMA SAMPLE DRAWN AND THAT WAS ALSO TESTED AND THE FT4 RESULT WAS 17.76 PMOL/L, THE TSH RESULT WAS 3.3378 UIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.