ELECSYS T4 ASSAY
Received Jan 29, 2019
Report 1823260-2019-90071 · MDR key 8285294
Device
Generic name
Radioimmunoassay, Total Thyroxine
Manufacturer
Roche DiagnosticsModel number
T4Lot number
ASKU
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. AS INSUFFICIENT PATIENT SAMPLE MATERIAL REMAINED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. FROM THE INFORMATION PROVIDED, A GENERAL REAGENT ISSUE COULD MOST LIKELY BE EXCLUDED. NO DEVICES WERE RETURNED. THIS DEVICE IS NOT LABELED FOR SINGLE USE AND IS NOT REPROCESSED OR REUSED.
Description of Event or Problem
THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENTS. ERRONEOUS HIGH ELECSYS T4 ASSAY RESULTS WERE GENERATED. THE EVENTS INVOLVED 1 PATIENT. THE PATIENT'S AGE WAS (B)(6). THE PATIENT'S WEIGHT WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENT WAS FEMALE. THE PATIENT'S RACE WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENT'S ETHNICITY WAS REQUESTED BUT WAS NOT PROVIDED.