BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 250 SYSTEM

    MDR report key: 582301 · Received March 17, 2005

    Report

    Report Number
    1319681-2005-00062
    Event Type
    Malfunction
    Date Received
    March 17, 2005
    Date of Event
    February 15, 2005
    Report Date
    February 16, 2005
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OCD FILED SERVICE WAS SENT TO THE CUSTOMER SITE AND DETERMINED THAT THE IMMUNOWASH FLUID (IWF) PUMP WAS LEAKING. THE IWF PUMP WAS REPLACED, AND PRECISION TESTING GAVE ACCEPTABLE RESULTS. THIS EVENT WAS CAUSED BY A MALFUNCTIONING IWF PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 250 SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA