ELECSYS FT4 IV
Received Oct 23, 2025
Report 1823260-2025-04323 · MDR key 23369459
Device
Generic name
Free Thyroxine
Manufacturer
Roche DiagnosticsModel number
FT4 IVCatalog number
09043284190
Lot number
852514
Product problems
- Low Test Results
- Low Test 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 DETERMINED THAT THE OBSERVED DIFFERENCE IN RESULTS IS ATTRIBUTABLE TO THE KNOWN METHODOLOGICAL DIFFERENCES BETWEEN THE ROCHE FT4 G4 ASSAY AND THE COMPETITOR'S (SIEMENS) ASSAY. NO PRODUCT PROBLEM WAS IDENTIFIED. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: A FINAL DATA ANALYSIS WAS PROVIDED TO THE CUSTOMER REGARDING ASSAY METHODOLOGY, CLINICAL INTERPRETATION, AND ESTABLISHING THEIR OWN REFERENCE RANGE. 3. DEVICE RETURNED TO MANUFACTURER? NO. 4. DEVICE LABELED "FOR SINGLE USE?" NO. 5. DEVICE REPROCESSED AND REUSED? NO.
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.
Description of Event or Problem
1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT4 IV ASSAY RESULTS FOR 7 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A COMPETITOR ASSAY. 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.