BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 435134 · Received December 20, 2002

    Report

    Report Number
    2250051-2002-00695
    Event Type
    Malfunction
    Date Received
    December 20, 2002
    Date of Event
    November 20, 2002
    Report Date
    December 11, 2002
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE PIPETTING MICROWELL PLATES ON SUMMIT, THE OPERATOR REPORTED THAT THE SUMMIT DID NOT PIPETTE INTO ROW H. NO ERROR WAS GENERATED BY THE SUMMIT. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO SUMMIT SAMPLE HANDLING SYSTEM SAMPLE PIPETTOR JTC ORTHO-CLINICAL DIAGNOSTICS 7003009 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other