BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO SUMMIT PROCESSOR

    MDR report key: 595232 · Received April 21, 2005

    Report

    Report Number
    2250051-2005-50135
    Event Type
    Other
    Date Received
    April 21, 2005
    Date of Event
    March 23, 2005
    Report Date
    April 21, 2005
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTL
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ORTHO SUMMIT PROCESSOR INSTRUMENT REPORTEDLY PROCESSED A MICROVELL PLATE WITH ONE ROW OF MICROWELLS ON THE PLATE CONSISTENTLY READING LOW 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