BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYBRID CAPTURE SYSTEM CMV DNA TEST VERSION 2.0

    MDR report key: 590926 · Received June 6, 2004

    Report

    Report Number
    1122376-2004-00001
    Event Type
    Malfunction
    Date Received
    June 6, 2004
    Report Date
    May 4, 2004
    Manufacturer
    DIGENE CORPORATION
    Product Code
    LJO
    Removal / Correction Number
    1122376-06/03/04-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CLINICAL LABORATORY REPORTED AN ESSAY VALIDATION FAILURE. THE REPORT INDICATED THAT ALL ASSAY VALUES, INCLUDING POSITIVE CONTROLS AND TARGETS, WERE VERY LOW. RETURNED PRODUCT WAS EVALUATED AND IT WAS DETERMINED THAT SOME OF THE TUBES WERE NOT COATED WITH ANTIBODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYBRID CAPTURE SYSTEM CMV DNA TEST VERSION 2.0 IN-VITRO DIAGNOSTIC LJO DIGENE CORPORATION NA 6234

    Patients

    Seq Age Sex Outcome Treatment
    1 *