MTS ID TIPMASTER PIPETTOR
Received Jun 27, 2007 · Event occurred May 29, 2007
Report 1056600-2007-00182 · MDR key 870914
Device
Generic name
Manual Pipettor
Manufacturer
Micro Typing Systems, Inc.Model number
NACatalog number
MTS9640
Lot number
AN
Product problems
- Fluid/Blood Leak
Patient
YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT MTS ID TIPMASTER PIPETTOR DRIPPED FLUID. FLUID DRIP FROM THE PIPETTOR CAN LEAD TO CARRY OVER / CROSS CONTAMINATION AND INCORRECT DISPENSE OF FLUID WHICH MAY LEAD TO VARIATIONS IN ANTIGEN / ANTIBODY RATIO AND POSSIBLE ERRONEOUS TEST RESULTS. THE CUSTOMER OBSERVED THE ISSUE AND TOOK THE PIPETTOR OUT OF USE, PREVENTING ERRONEOUS RESULTS FROM BEING REPORTED.
Additional Manufacturer Narrative
THE PIPETTE IS NO LONGER COVERED UNDER WARRANTY. THE CUSTOMER WAS INSTRUCTED TO DISCONTINUE USE OF THIS INSTRUMENT. THE INSTRUMENT WAS NOT RETURNED FOR EVALUATION, AND THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.