MalfunctionJZT
VIDAS INSTRUMENT
Received Apr 8, 2005 · Event occurred Mar 10, 2005
Report 3002769706-2005-00013 · MDR key 592128
Device
Generic name
Discrete Wavelength Flurometer
Manufacturer
Biomerieux, Inc.Model number
NACatalog number
99011
Lot number
NA
Product problems
- Incorrect Or Inadequate Test Results
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A FALSE VALUE WAS REPORTED ON THE VIDAS DIGOXIN ASSAY. THE FALSE RESULTS WAS DUE TO A PUMP SEAL INCORRECTLY POSITIONED THUS CAUSING A PIPETTING ERROR. THE PATIENT WAS ALREADY ON DIGOXIN THERAPY AND THE INCORRECT RESULT DID NOT AFFECT OR ALTER THE PATIENT'S THERAPY.
Remedial action
- Other