BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT PROCESSOR

    MDR report key: 479321 · Received August 13, 2003

    Report

    Report Number
    2250051-2003-01099
    Event Type
    Malfunction
    Date Received
    August 13, 2003
    Date of Event
    July 31, 2003
    Report Date
    August 13, 2003
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    GKH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER PROCESSING 20 PLATES ON THE ORTHO SUMMIT PROCESSOR PLATE REPORTS SHOWED THAT SOME OF THE WELLS IN ROW H HAD OPTICAL DENSITY READINGS THAT WERE IDENTIFIED AS BEING "LOW". NO ERROR WAS GENERATED BY THE OSP. 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 SAMPLE PROCESSOR GKH ORTHO-CLINICAL DIAGNOSTICS 7003015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other