BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5, 1 FS CHEMISTRY ANALYZER

    MDR report key: 1052412 · Received May 20, 2008

    Report

    Report Number
    1319681-2008-00145
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 21, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT CONCLUDES THAT THE INSTRUMENT AND REAGENT WERE PERFORMING AS EXPECTED. THE HISTORICAL CALIBRATION AND SAMPLE HANDLING COULD NOT BE RULED OUT AS POTENTIAL CONTRIBUTORS TO THE EVENT. THE ROOT CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED NEGATIVELY BIASED PHBR RESULTS ON THE VITROS 5,1 ANALYZER. BIASED RESULTS WERE NOT RELEASED. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. NOTE: THE 3500A FORMS FOR MFR. REPORT # 1319681-2008-00144 AND 1319681-2008-00145 ARE IDENTICAL WITH THE EXCEPTION OF THE SPECIFIC SERIAL# AND MFG. DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 5, 1 FS CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1