MalfunctionKZS
ORTHO PROVUE ANALYZER
Received May 25, 2006 · Event occurred Apr 24, 2006
Report 1056600-2006-00074 · MDR key 721307
Device
Generic name
Automated Blood Grouping And Antibody Test System
Manufacturer
Micro Typing Systems, Inc.Model number
MTS213784Catalog number
ORTHO PROVUE
Lot number
*
Product problems
- Leak/Splash
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEY OBSERVED LEAKING FROM THE PROBE AREA OF THE ORTHO PROVUE ANALYZER.
Remedial action
- Repair