MalfunctionJZT
VIDAS
Received Sep 13, 2001 · Event occurred Aug 28, 2001
Report 1950204-2001-00015 · MDR key 351836
Device
Generic name
Immunoflurometric Equipment
Manufacturer
Biomerieux, Inc.Model number
VIDAS 30Catalog number
W2010
Lot number
NA
Product problems
- Repair
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
CUSTOMER CALLED EUROPEAN OFFICE TO COMPLAIN OF INCORRECT RESULTS USING CO'S RBG ASSAY. FIELD SVC WAS DISPATCHED AND AFTER TESTING THE PUMP REPLACED THE PUMP. FURTHER ANALYSIS BY ENGINEERING STAFF REVEALED THAT THE PUMP WAS CLOGGED.
Remedial action
- Notification
- Inspection
- Repair
- Replace