BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5, 1 CHEMISTRY SYSTEM

    MDR report key: 1203387 · Received October 14, 2008

    Report

    Report Number
    1319681-2008-00308
    Event Type
    Malfunction
    Date Received
    October 14, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 18, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT CONCLUDED THAT IMPRECISE PHYT RESULTS WERE OCCURRING. AN OCD FIELD ENGINEER INVESTIGATED AND MADE REPAIRS TO THE IMMUNOWASH FLUID MODULE. FOLLOWING SERVICE, THE ISSUE WAS RESOLVED. THE ROOT CAUSE OF THE EVENT IS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED NEGATIVELY BIASED QUALITY CONTROL PHYT RESULTS WHILE USING THE VITROS 5, 1 ANALYZER. PATIENT SAMPLE RESULTS WERE NOT REPORTED WHILE QUALITY CONTROL RESULTS WERE UNACCEPTABLE. 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. COMPLAINT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1