BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROSS 250 CHEMISTRY SYSTEM

    MDR report key: 2982281 · Received November 2, 2007

    Report

    Report Number
    1319681-2007-00321
    Event Type
    Malfunction
    Date Received
    November 2, 2007
    Date of Event
    October 5, 2007
    Report Date
    October 5, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT FOUND THAT THE POSITIVELY BIASED RESULTS WERE THE RESULT OF USER ERROR IN NOT FOLLOWING THE MFR'S RECOMMENDATION FOR THE RECONSTITUTION CALIBRATOR KIT 2. CALIBRATOR KIT 2 IS USED TO CALIBRATE THE VITROS K+ ASSAY.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED POSITIVELY BIASED K+ QC RESULTS ON A VITROS 250 ANALYZER. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WERE NO ALLEGATIONS OF HARM. THE REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROSS 250 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1