ELECSYS T4 ASSAY
Received Jul 26, 2019
Report 1823260-2019-90176 · MDR key 8830160
Device
Generic name
Radioimmunoassay, Total Thyroxine
Manufacturer
Roche DiagnosticsModel number
T4Lot number
ASKU
Product problems
- Low Test Results
- Low 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 COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THERE WERE NO FOLLOW UP ACTIONS. 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 EVENT. DISCREPANT LOW RESULTS WERE GENERATED BY A COBAS 6000 E 602 MODULE. THE EVENTS INVOLVED A TOTAL OF 1 PATIENT WITH THE FOLLOWING: ONE SAMPLE WITH DISCREPANT RESULTS FOR THE ELECSYS T4 ASSAY. THE PATIENT'S AGE WAS (B)(6) YEARS. THE PATIENT'S GENDER WAS MALE.