BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 950 CHEMISTRY SYSTEM

    MDR report key: 690986 · Received October 18, 2005

    Report

    Report Number
    1319681-2005-00252
    Event Type
    Malfunction
    Date Received
    October 18, 2005
    Date of Event
    September 20, 2005
    Report Date
    September 21, 2005
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED PT SAMPLE RESULTS ASSOCIATED WITH THE WRONG PT DEMOGRAPHICS ON THE 950 ANALYZER. MIS-ASSOCIATION OF PT DEMOGRAPHICS AND RESULTS MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE INCORRECT PT RESULT WAS NOT REPORTED. 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 950 CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJJ ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA