BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO SUMMIT PROCESSOR

    MDR report key: 592352 · Received April 13, 2005

    Report

    Report Number
    2250051-2005-50118
    Event Type
    Other
    Date Received
    April 13, 2005
    Date of Event
    March 17, 2005
    Report Date
    April 13, 2005
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTL
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ORTHO SUMMIT PROCESS INSTRUMENT REPORTEDLY PROCESSED 12 MICROWELL PLATES WITH ONE ROW OF MICROWELLS ON EACH PLATE CONSISTENTLY READING JOW ODS AND NEGATIVE ODS. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO SUMMIT PROCESSOR ELISA MICROWELL PLATE PROCESSOR JTL HAMILTON BONADUZ AG 7003015 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other