ELECSYS T4 ASSAY
Received Nov 25, 2020 · Event occurred Nov 3, 2020
Report 1823260-2020-03007 · MDR key 10900403
Device
Generic name
Radioimmunoassay, Total Thyroxine
Manufacturer
Roche DiagnosticsModel number
T4Catalog number
ASKU
Lot number
ASKU
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. THIS EVENT OCCURRED IN (B)(4).
Description of Event or Problem
THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS T4 ASSAY RESULT FOR ONE PATIENT FROM ELECSYS 2010 DISK ANALYZER SERIAL NUMBER (B)(4). THE CUSTOMER SUSPECTED INTERFERENCE AS THE RESULT DID NOT FIT THE CLINICAL PICTURE IN A PATIENT WITH MULTIPLE SCLEROSIS UNDER TREATMENT WITH THE IMMUNOREGULATING DRUG COPARAXON 40 (GLATIRAMER). THE T4 RESULT WAS 15.33 G/DL. INFORMATION WAS REQUESTED IF ANY QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY, BUT IT WAS NOT KNOWN.