ELECSYS FT4 IV
Received Apr 27, 2026
Report 1823260-2026-01641 · MDR key 25002178
Device
Generic name
Free Thyroxine
Manufacturer
Roche DiagnosticsModel number
FT4 IVCatalog number
09043284190
Lot number
891745
Product problems
- High Test Results
- Output Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION IS ONGOING. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE SAMPLE WAS REQUESTED FOR INVESTIGATION. 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 ELECSYS FT4 IV RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. 2. PATIENT AGE RANGE: 80-YEARS-OLD. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: MALE. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.