BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS CKMB SLIDES

    MDR report key: 579988 · Received November 23, 2004

    Report

    Report Number
    9680658-2004-00308
    Event Type
    Malfunction
    Date Received
    November 23, 2004
    Date of Event
    October 28, 2004
    Report Date
    October 29, 2004
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED LOW QC RESULTS WHEN RUNNING CK-MB SLIDES ON THE VITORS 250 CHEMISTRY SYSTEM. NEGATIVELY BIASED RESULTS COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS CKMB SLIDES CLINICAL CHEMISTRY SLIDES JJT ORTHO-CLINICAL DIAGNOSTICS NA 4911-0141-3647

    Patients

    Seq Age Sex Outcome Treatment
    1 NA