ELECSYS T4 ASSAY
Received Nov 29, 2017 · Event occurred Mar 7, 2017
Report 1823260-2017-02772 · MDR key 7067047
Device
Generic name
Radioimmunoassay, Total Thyroxine
Manufacturer
Roche DiagnosticsModel number
NACatalog number
12017709122
Lot number
19428105
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
(B)(4). THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR MULTIPLE ASSAYS FOR ONE PATIENT FROM AN UNKNOWN ROCHE ANALYZER. THE RESULTS WERE REPORTED TO THE ENDOCRINOLOGIST. THE PATIENT WAS UNDER GROWTH HORMONE SUPPLEMENTATION THERAPY WITH SAIZEN AND THE ENDOCRINOLOGIST CLAIMED THE RESULTS DID NOT FIT THE CLINICAL PICTURE. INTERFERENCE WAS SUSPECTED. OF THE DATA PROVIDED ONLY THE RESULTS FOR ELECSYS TSH ASSAY, ELECSYS T4 ASSAY, AND ELECSYS ESTRADIOL III ASSAY WERE A REPORTABLE MALFUNCTION. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. (B)(4).
Additional Manufacturer Narrative
SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION AND AN INTERFERING FACTOR TO A COMPONENT OF THE ASSAY WAS FOUND IN THE SAMPLE. PRODUCT LABELING FOR THE ASSAY DOCUMENTS THIS INTERFERENCE. THE INCIDENCE RATE OF THE IDENTIFIED INTERFERING FACTOR IS MONITORED ON A QUARTERLY BASIS.