MalfunctionJZT
VIDAS
Received Sep 12, 2001 · Event occurred Sep 5, 2001
Report 1950204-2001-00014 · MDR key 351841
Device
Generic name
Immunoflurometric Equipment
Manufacturer
Biomerieux, Inc.Model number
VIDAS 30Catalog number
W2010
Lot number
NA
Product problems
- Failure to Pump
- Replace
- 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 COMPLAINED OF OBTAINING THREE INCORRECT RESULTS. FIELD SVC CONFIRMED PUMP FAILURE AND REPLACED THE PUMP. U.S. ENGINEERING CONFIRMED THAT THE PUMP WAS CLOGGED.
Remedial action
- Repair
- Inspection
- Notification
- Replace