BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT PROCESSOR

    MDR report key: 450309 · Received March 21, 2003

    Report

    Report Number
    2250051-2003-00668
    Event Type
    Malfunction
    Date Received
    March 21, 2003
    Date of Event
    April 1, 2002
    Report Date
    March 18, 2003
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JTL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A REVIEW OF THE OCD COMPLAINT SYSTEM, THIS INCIDENT WAS DEEMED TO BE SIMILAR IN NATURE TO RECENTLY REPORTED EVENTS CONCERNING NEGATIVE ODS ON THE ORTHO SUMMIT PROCESSOR. THE CUSTOMER REPORTED THAT AFTER PIPETTING AN HBSAG MICROWELL PLATE ON OSP, NEGATIVE ODS WERE REPORTED IN SOME OF THE ROWS OF THE MICROWELL PLATE. NO ERROR WAS REPORTED. 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 JTL ORTHO-CLINICAL DIAGNOSTICS 7003015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other