ELECSYS T4 ASSAY
Received Oct 15, 2018 · Event occurred Sep 18, 2018
Report 1823260-2018-03669 · MDR key 7965362
Device
Generic name
Radioimmunoassay, Total Thyroxine
Manufacturer
Roche DiagnosticsModel number
NACatalog number
ASKU
Lot number
ASKU
Product problems
- High Test Results
- High Test Results
Patient
62 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(6).
Description of Event or Problem
THE CUSTOMER RECEIVED QUESTIONABLE THYROID RESULTS FOR ONE PATIENT SAMPLE FROM COBAS 8000 COBAS E 602 MODULE SERIAL NUMBER (B)(4) WHEN COMPARED TO THE RESULTS FROM AN ABBOTT ARCHITECT. THE RESULTS FROM THE COBAS E602 DID NOT CORRELATE WITH PATIENT SYMPTOM AND AN INTERFERENCE WAS SUSPECTED. THIS MEDWATCH IS FOR ELECSYS T4 ASSAY. REFER TO THE FOLLOWING MEDWATCH WITH PATIENT IDENTIFIER FOR THE OTHER ASSAYS INVOLVED: ELECSYS TSH ASSAY=(B)(6). ELECSYS T3 ASSAY=(B)(6). ELECSYS FT3=(B)(6). ELECSYS FT4 ASSAY=(B)(6). THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.
Additional Manufacturer Narrative
THE CUSTOMER PROVIDED SAMPLES FOR INVESTIGATION. THE RESULT DIFFERENCE OF T3 AND T4 WAS CAUSE BY AN INTERFERING FACTOR TO A COMPONENT OF THE REAGENT. THIS TYPE OF INTERFERING FACTOR IS ADDRESSED IN THE RESPECTIVE PRODUCT LABELING.