BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT PROCESSOR

    MDR report key: 430512 · Received November 27, 2002

    Report

    Report Number
    2250051-2002-00690
    Event Type
    Malfunction
    Date Received
    November 27, 2002
    Date of Event
    October 24, 2002
    Report Date
    November 20, 2002
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE PROCESSING MICROWELL PLATES ON ORTHO SUMMIT PROCESSOR, THE OSP REPORTED NEGATIVE ABSORBANCES IN ROW G AND H. 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 JTC ORTHO-CLINICAL DIAGNOSTICS 7003009 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other