BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE ANALYZER

    MDR report key: 721307 · Received May 25, 2006

    Report

    Report Number
    1056600-2006-00074
    Event Type
    Malfunction
    Date Received
    May 25, 2006
    Date of Event
    April 24, 2006
    Report Date
    May 24, 2006
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KZS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY OBSERVED LEAKING FROM THE PROBE AREA OF THE ORTHO PROVUE ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO PROVUE ANALYZER AUTOMATED BLOOD GROUPING AND ANTIBODY TEST SYSTEM KZS MICRO TYPING SYSTEMS, INC. MTS213784 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other