MalfunctionIZT
MINIVIDAS
Received Nov 12, 2001 · Event occurred Oct 8, 2001
Report 1950204-2001-00016 · MDR key 360507
Device
Generic name
Immunoflurometric Equipment
Manufacturer
Biomerieux, Inc.Model number
MINIVIDASCatalog number
W2011
Lot number
NA
Product problems
- Device Issue
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
CUSTOMER WAS RUNNING "QCT" TEST STRIPS ON PUMP AND FAILED THE TEST 4 TIMES. QCR TEST IS A TEST TO DETECT CLOGGED PUMP TUBES. CLOGGED PUMP TUBES COULD RESULT IN FALSE RESULTS BEING REPORTED TO THE PT. THERE ARE NO REPORTS OF FALSE RESULTS BEING GENERATED AT THIS SITE.
Remedial action
- Replace
- Notification
- Inspection
- Repair