BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 3132278 · Received May 29, 2013

    Report

    Report Number
    2250051-2013-00153
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 28, 2013
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    MMH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FE ARRIVED ON SITE AND INVESTIGATED THE REPORTED ISSUE ON THE INSTRUMENT. THE FE INSPECTED THE INSTRUMENT AND FOUND THE PLUNGER CLAMP BROKEN. THE FE REPLACED THE PLUNGER CLAMP AT POSITION #6. THE FE PERFORMED SPLLD CHECKING PROCEDURE, BOOT TEST, AND TESTED THE SUMMIT WITH OAS USER SOFTWARE. THE INSTRUMENT WAS TESTED WITHOUT PROBLEM. THE INSTRUMENT IS NOW PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    THE ORTHO SUMMIT SAMPLE HANDLING SYSTEM INSTRUMENT REPORTEDLY DID NOT PIPETTE SAMPLE AND DID NOT GENERATE AN ERROR MESSAGE. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237556 ORTHO SUMMIT SAMPLE HANDLING SYSTEM SAMPLE PIPETTOR MMH HAMILTON BONADUZ AG

    Patients

    Seq Age Sex Outcome Treatment
    1