BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS CKMB SLIDES

    MDR report key: 592759 · Received June 8, 2004

    Report

    Report Number
    1319809-2005-00118
    Event Type
    Malfunction
    Date Received
    June 8, 2004
    Date of Event
    May 17, 2004
    Report Date
    May 17, 2004
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBSERVING FALSELY LOW CKMB RESULTS USING A QC FLUID. FALSE LOW RESULTS MIGHT LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THER WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS CKMB SLIDES IN VITRO DIAGNOSTIC JJT ORTHO-CLINICAL DIAGNOSTICS, INC. NA 4912-0130-5667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA