ELECSYS T4 ASSAY
Received Jan 29, 2020
Report 1823260-2020-90035 · MDR key 9641140
Device
Generic name
Radioimmunoassay, Total Thyroxine
Manufacturer
Roche DiagnosticsModel number
T4Catalog number
07027885190
Lot 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
FOR THE PENDING EVENT, INVESTIGATION OF THE PATIENT SAMPLE FOUND AN INTERFERENCE TO STREPTAVIDIN AND AN IMMUNOGLOBULIN THAT REACTS WITH THE REAGENT WHICH AFFECTS THE SAMPLE RESULTS. THIS INTERFERENCE IS DOCUMENTED IN PRODUCT LABELING FOR THE ASSAY: IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN.
Additional Manufacturer Narrative
THE INVESTIGATION OF THE EVENT IS CURRENTLY ONGOING. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. 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. QUESTIONABLE HIGH ELECSYS T4 ASSAY RESULTS WERE GENERATED BY A COBAS 6000 E601 MODULE. THE EVENT INVOLVED ONE PATIENT SAMPLE. THE PATIENT'S AGE WAS REQUESTED, BUT NOT PROVIDED. THE PATIENT'S WEIGHT WAS REQUESTED, BUT NOT PROVIDED. THE PATIENT IS MALE. THE PATIENT'S RACE WAS REQUESTED, BUT NOT PROVIDED. THE PATIENT'S ETHNICITY WAS REQUESTED, BUT NOT PROVIDED.