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MalfunctionGJG

MTS ID TIPMASTER PIPETTOR

Received Oct 11, 2007 · Event occurred Sep 12, 2007

Report 1056600-2007-00289 · MDR key 925763

Device

Generic name

Manual Pipettor

Model number

NA

Catalog number

MTS9640

Lot number

NA

Product problems

  • Inaccurate Delivery

Patient

YR

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY HAD OBSERVED AN INCORRECT AMOUNT OF FLUID DISPENSED FROM THE MTS ID TIPMASTER PIPETTOR. INCORRECT DISPENSE OF FLUID 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

EVALUATION OF PIPETTOR HAD NOT BEEN PERFORMED AT THE TIME OF THIS REPORT AND WAS PENDING THE RETURN OF THE EQUIPMENT. THE CUSTOMER'S COMPLAINT WAS RESOLVED BY PROVIDING EQUIPMENT REPLACEMENT. THIS CUSTOMER HAD NOT LOGGED ANY COMPLAINTS AGAINST THIS PIPETTOR SINCE THIS INCIDENT.