ELECSYS T4 ASSAY
Received May 16, 2019
Report 1823260-2019-90164 · MDR key 8615535
Device
Generic name
Radioimmunoassay, Total Thyroxine
Manufacturer
Roche DiagnosticsModel number
T4Lot number
34444100
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 INVESTIGATIONS FOR THE 1 EVENT IS ONGOING. THE SUMMARY OF THE INVESTIGATION RESULTS ARE NOT YET AVAILABLE. THE FOLLOW UP/CORRECTIVE ACTIONS FOR THE 1 EVENT IS NOT YET AVAILABLE. 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. AN ERRONEOUS LOW RESULT WAS GENERATED BY THE COBAS 8000 E 602 MODULE. THE EVENTS INVOLVED A TOTAL OF 1 PATIENT WITH THE FOLLOWING: A LOW T4 RESULT NOT MATCHING THE PATIENT'S CLINICAL PICTURE. THE PATIENT'S AGE WAS (B)(6) YEARS OLD. THE PATIENT'S GENDER WAS MALE.
Additional Manufacturer Narrative
THE INVESTIGATION DETERMINED THAT BASED ON THE DATA PROVIDED, A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE LOW T4 RESULTS CORRESPOND TO THE OTHER RELATED THYROID RESULTS WHICH SUGGESTS THE LOW T4 RESULTS ARE CORRECT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.