BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK

    MDR report key: 503472 · Received December 11, 2003

    Report

    Report Number
    9680658-2003-00285
    Event Type
    Malfunction
    Date Received
    December 11, 2003
    Date of Event
    November 13, 2003
    Report Date
    November 13, 2003
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JHY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING INVESTIGATION OF VITROS CK-MB CALIBRATION FAIURES, A CUSTOMER REPORTED GENERATING NEGATIVELY BIASED RESULTS FOR ALL LEVELS OF BIORAD CARDIOLOGY LT CONTROLS. A MALFUNCTION OF THIS TYPE COULD CAUSE BIASED RESULTS IN ASSAYS THAT MAY BE USED IN CRITICAL DIAGNOSTIC APPLICATIONS. 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 IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK IN-VITRO DIAGNOSTIC JHY ORTHO-CLINICAL DIAGNOSTICS NA 611

    Patients

    Seq Age Sex Outcome Treatment
    1 NA