BEUDAMED
    FDA Adverse Event Other Summary report: N

    BENCHMARK

    MDR report key: 529409 · Received February 24, 2004

    Report

    Report Number
    2028492-2004-00001
    Event Type
    Other
    Date Received
    February 24, 2004
    Date of Event
    January 2, 2004
    Report Date
    February 24, 2004
    Manufacturer
    VENTANA MEDICAL SYSTEMS, INC.
    Product Code
    KPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PREVIOUS REPORT SPECIFIED AN ISSUE WITH THE BENCHMARK INSTRUMENTS WHICH MAY HAVE NOT BEEN CONCLUSIVE. IN-PROCESS STUDIES SUGGEST THAT THE STAINING FLUCTUATION MAY BE ATTRIBUTABLE TO MIXING DIFFICULTIES ON THE SLIDE. THE SLIDES USED BY THE SITE WITH THE PAINTED BOX APPEAR MORE SUSCEPTIBLE TO THE VARIATION THAN SUPERFROST PLUS. THE EXACT NATURE OF THE MIXING INCONSISTENCY IS UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BENCHMARK AUTOSTAINER KPA VENTANA MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other