ELECSYS FT4 III ASSAY
Received Sep 28, 2020 · Event occurred Aug 28, 2020
Report 1823260-2020-02372 · MDR key 10592676
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Roche DiagnosticsModel number
NACatalog number
07976887190
Lot number
ASKU
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE PATIENT SAMPLE WAS RETURNED FOR INVESTIGATION. THE SAMPLE WAS TESTED FOR INTERFERENCES. NO INTERFERING FACTOR WAS FOUND THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. ASSAYS FROM DIFFERENT VENDORS CAN GENERATE DIFFERENT VALUES. THIS RELATES TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED AND, DIFFERENCES IN REFERENCE MATERIALS/METHODS AND THE STANDARDIZATION METHODOLOGY USED.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT4 III ASSAY RESULTS ON A COBAS 8000 COBAS E 801 MODULE, SERIAL NUMBER (B)(4). THE ELECSYS FT4 III ASSAY RESULT WAS 2.08 NG/DL. THE ABBOTT INSTRUMENT'S RESULT WAS 1.38 NG/DL. THE ELECSYS RESULT WAS REPORTED TO THE PATIENT'S PHYSICIAN, WHO QUESTIONED THE RESULT, AND REQUESTED THE SAMPLE TO BE REPEATED ON AN ABBOTT INSTRUMENT.