ELECSYS FT3 III
Received Apr 27, 2026
Report 1823260-2026-01648 · MDR key 25002377
Device
Generic name
Total Triiodothyronine
Manufacturer
Roche DiagnosticsModel number
FT3 IIICatalog number
09005811190
Lot number
88587401
Product problems
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
1. SUMMARY OF INVESTIGATION RESULTS: AS THE SAMPLE WAS NOT AVAILABLE, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: THE SAMPLE WAS REQUESTED FOR INVESTIGATION; HOWEVER, NO SAMPLE MATERIAL IS AVAILABLE FOR FURTHER TESTING. 3. DEVICE RETURNED TO MANUFACTURER? NO 4. DEVICE LABELED "FOR SINGLE USE?" NO. 5. DEVICE REPROCESSED AND REUSED? NO.
Description of Event or Problem
1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS FT3 III ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO THE MINDRAY METHOD. 2. PATIENT AGE RANGE: 11 YEARS 3. PATIENT WEIGHT RANGE: ASKU 4. PATIENT SEX BREAKDOWN: MALE 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.