BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 250 CHEMISTRY SYSTEM

    MDR report key: 715681 · Received May 16, 2006

    Report

    Report Number
    1319681-2006-00108
    Event Type
    Malfunction
    Date Received
    May 16, 2006
    Date of Event
    April 17, 2006
    Report Date
    April 17, 2006
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED POSITIVELY BIASED K + QC RESULTS ON THE VITROS 250 ANALYZER. NO BIASED PT RESULTS WERE REPORTED. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE 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 250 CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA