ELECSYS T4 ASSAY
Received Jul 28, 2020
Report 1823260-2020-90119 · MDR key 10331934
Device
Generic name
Radioimmunoassay, Total Thyroxine
Manufacturer
Roche DiagnosticsModel number
T4Catalog number
12017709122
Lot number
38326800, 41543400
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, THE PATIENT'S SAMPLE WAS PROVIDED FOR INVESTIGATION. THE INVESTIGATION REPRODUCED AND CONFIRMED THE CUSTOMER'S T4 RESULT. AN INTERFERING FACTOR AGAINST A COMPONENT OF THE REAGENT WAS IDENTIFIED. THE INTERFERING FACTOR WAS STREPTAVIDIN. PER LABELING, "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. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE INVESTIGATION OF THE EVENT IS CURRENTLY ONGOING. THIS DEVICE IS NOT LABELED FOR SINGLE USE AND IS NOT REPROCESSED OR REUSED.
Description of Event or Problem
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT. QUESTIONABLE HIGH RESULTS WERE GENERATED FOR THE ELECSYS T4 ASSAY ON A COBAS 8000 E 602 MODULE. THE EVENT INVOLVED ONE PATIENT SAMPLE. THE PATIENTS' AGE WAS "APPROXIMATELY 50 YEARS". 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.