BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 1520866 · Received October 29, 2009

    Report

    Report Number
    1319681-2009-00344
    Event Type
    Malfunction
    Date Received
    October 29, 2009
    Date of Event
    October 1, 2009
    Report Date
    October 1, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IDENTIFIED A PRECISION ISSUE AFFECTING BOTH VITROS PHBR AND VITROS CRBM PERFORMANCE. VITROS AND NON-VITROS QUALITY CONTROL FLUIDS WERE AFFECTED. OCD FIELD SERVICE INVESTIGATED AND PERFORMED NECESSARY ADJUSTMENTS TO MULTIPLE SUBSYSTEMS OF THE VITROS 5,1. POST-SERVICE VITROS QUALITY CONTROL WAS ACCEPTABLE, HOWEVER, PHBR AND CRBM PRECISION WITH NON-VITROS QUALITY CONTROL FLUIDS REMAINED UNACCEPTABLE. OCD FIELD SERVICE WILL INVESTIGATE AND VERIFY THAT THE VITROS 5,1 IS OPERATING AS EXPECTED. THE ROOT CAUSE OF THIS EVENT IS MOST LIKELY INSTRUMENT RELATED. THE INVESTIGATION IS ON-GOING.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED NEGATIVELY BIASED QUALITY CONTROL RESULTS PROCESSED USING VITROS PHBR SLIDES ON A VITROS 5, 1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. PATIENT SAMPLES WERE NOT PROCESSED FOR PHBR WHILE QUALITY CONTROL WAS UNACCEPTABLE. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1