BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5.1 FS CHEMISTRY SYSTEM

    MDR report key: 948879 · Received November 16, 2007

    Report

    Report Number
    1319681-2007-00346
    Event Type
    Malfunction
    Date Received
    November 16, 2007
    Date of Event
    October 21, 2007
    Report Date
    October 21, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT FOUND THAT REPLACING THE IMMUNOWASH (IWF) TUBING RESOLVED THE ISSUE. FOLLOWING THE REPLACEMENT OF IWF TUBING AND RECALIBRATION, QUALITY CONTROL RESULTS WERE ACCEPTABLE. THE ROOT CAUSE OF THIS EVENT IS ANALYZER RELATED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED POSITIVELY BIASED, IMPRECISE PHYT QC RESULTS ON THE VITROS 5.1 FS ANALYZER. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY RESULT IN INAPPROPRIATE PHYSICIAN ACTION. 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 5.1 FS CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR