VIDAS INSTRUMENT
Received Mar 23, 2005 · Event occurred Mar 4, 2005
Report 3002769706-2005-00010 · MDR key 586124
Device
Generic name
Discrete Wavelength Fluorometer
Manufacturer
Biomerieux, Inc.Model number
NACatalog number
527001-6903
Lot number
NA
Product problems
- False Negative Result
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 H. PYLORI ASSAY RESULT PRODUCED A FALSE NEGATIVE. THE VIDAS H. PYLORI ASSAY IS AN ASSAY FOR THE DETECTION OF IGC ANTIBODIES TO HELICOBACTER PYLORI. THIS FALSE RESULT WAS REPORTED TO THE PHYSICIAN. HOWEVER, NO ADVERSE EFFECTS ON TREATMENT OF THE PT OCCURRED.
Remedial action
- Other