ELECSYS FT4 IV
Received Oct 23, 2025
Report 1823260-2025-04319 · MDR key 23369426
Device
Generic name
Free Thyroxine
Manufacturer
Roche DiagnosticsModel number
FT4 IVCatalog number
09043284190
Lot number
868732
Product problems
- Low Test Results
- Non Reproducible Results
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: THE FIELD SERVICE ENGINEER CHECKED THE INSTRUMENT AND THE SAMPLE NEEDLE AND RESTORED THE FLUID CONNECTION.
Description of Event or Problem
1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR 1 PATIENT NOT MATCHING THE PATIENT'S CLINICAL HISTORY WHEN TESTED FOR ELECSYS FT4 IV ON A COBAS E 801 ANALYTICAL UNIT AND COMPARED TO A DIFFERENT COBAS ANALYZER. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.
Additional Manufacturer Narrative
1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION IS ONGOING. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE INVESTIGATION IS ONGOING. 3. DEVICE RETURNED TO MANUFACTURER? NO. 4. DEVICE LABELED "FOR SINGLE USE?" NO. 5. DEVICE REPROCESSED AND REUSED? NO.