inforMED
MalfunctionJTC

ORTHO SUMMIT SAMPLE HANDLING SYSTEM

Received Jul 20, 2007 · Event occurred Jun 27, 2007

Report 2250051-2007-70372 · MDR key 975062

Device

Generic name

Sample Pipetter

Model number

7003009

Catalog number

936400

Lot number

*

Product problems

  • Alarm, failure of warning
  • Pipette, failure to aspirate

Patient

*

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

THE ORTHO SUMMIT SAMPLE HANDLING SYSTEM INSTRUMENT REPORTEDLY DID NOT PIPETTE SAMPLE/REAGENT AND DID NOT GENERATE AN ERROR MESSAGE. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.