BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 484615 · Received September 16, 2003

    Report

    Report Number
    2250051-2003-01168
    Event Type
    Malfunction
    Date Received
    September 16, 2003
    Date of Event
    September 9, 2003
    Report Date
    September 12, 2003
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER PIPETTING AN HBC PLATE ON SUMMIT, THE TECHNICIAN OBSERVED BUBBLES AND LOWER REAGENT VOLUME IN ROW H OF THE MICROWELL PLATE. NO ERROR WAS GENERATED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO SUMMIT SAMPLE HANDLING SYSTEM SAMPLE HANDLER JTC ORTHO-CLINICAL DIAGNOSTICS 7003009 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other