ELECSYS T4
Received Oct 2, 2024 · Event occurred Sep 10, 2024
Report 1823260-2024-02851 · MDR key 20353244
Device
Generic name
Radioimmunoassay, Total Thyroxine
Manufacturer
Roche DiagnosticsModel number
T4Catalog number
09007784190
Lot number
ASKU
Product problems
- High Test Results
- Insufficient Device Problem Information
- Non Reproducible Results
- High Test Results
- Insufficient Device Problem Information
- Non Reproducible Results
Patient
63 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE FIELD SERVICE ENGINEER CHECKED THE ANALYZER AND FOUND NO HARDWARE ISSUES. HE PERFORMED PREVENTIVE MAINTENANCE AND THE CUSTOMER PERFORMED AN INSTRUMENT CHECK WHICH WAS SUCCESSFUL. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T4 RESULTS FROM THE COBAS E 801 MODULE. THE INITIAL RESULT WAS 17.9 G/DL AND THE REPEAT RESULT WAS 7.87 G/DL.