VIDAS INSTRUMENT
Received Mar 23, 2005 · Event occurred Feb 21, 2005
Report 3002769706-2005-00009 · MDR key 586110
Device
Generic name
Discrete Wavelength Fluorometer
Manufacturer
Biomerieux, Inc.Model number
NACatalog number
UNK
Lot number
NA
Product problems
- High Test Results
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE VIDAS INSTRUMENT IS A DISCRETE WAVELENGTH FLUOROMETER. THE INSTRUMENT HAS 5 SECTIONS WITH 6 POSITIONS PER SECTION. THE POSITIONS OPERATE MECHANICALLY INDEPENDENT OF EACH OTHER AND EACH POSITION CONTAINS A SAMPLE. THE CUSTOMER REPORTED ONE POSITION TO BE OUT OF RANGE WHEN A QUALITY CONTROL TEST WAS RUN. THE CUSTOMER THEN DISCOVERED THAT ONE VIDAS FT4 ASSAY RESULT WAS FALSE. THE VIDAS FT4 ASSAY IS AN ELISA ASSAY FOR THE DETERMINATION OF HUMAN FREE THYROXINE (FT4) CONCENTRATION. THE TEST PROVIDED A RESULT OF 55 PMOL/1 INSTEAD OF 12.74 PMOL/1. THIS FALSE RESULT WAS REPORTED TO THE PHYSICIAN. NO ADVERSE EFFECTS ON TREATMENT OF THE PT WERE REPORTED TO BIOMERIEUX.
Remedial action
- Other