MalfunctionJZT
VIDAS
Received Sep 13, 2001 · Event occurred Jul 23, 2001
Report 1950204-2001-00013 · MDR key 351846
Device
Generic name
Immunoflurometric Equipment
Manufacturer
Biomerieux, Inc.Model number
VIDAS 30Catalog number
W2010
Lot number
NA
Product problems
- 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 OVERSEAS CALLED TO COMPLAIN ABOUT A INCORRECT PT RESULT. FIELD SVC EXAMINED THE INSTRUMENT AND DETERMINED THAT THE PUMP NEEDED TO BE REPLACED. THE PUMP WAS RETURNED TO CO'S OVERSEAS HEADQUARTERS AS BEING POSSIBLY CLOGGED. CO'S ENGINEERS CONFIRMED THAT THE PUMP WAS CLOGGED.
Remedial action
- Notification
- Inspection
- Replace
- Repair