BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 250 CHEMISTRY SYSTEM

    MDR report key: 797827 · Received December 18, 2006

    Report

    Report Number
    1319681-2006-00284
    Event Type
    Malfunction
    Date Received
    December 18, 2006
    Date of Event
    November 28, 2006
    Report Date
    November 28, 2006
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT DETERMINED THAT THERE WERE SALT DEPOSITS ON THE ELECTROLYTE REFERENCE FLUID (ERF) EVAPORATION COVER. CLEANING OF THE EVAPORATION COVER RESTORED THE SYSTEM TO EXPECTED OPERATION. THE ROOT CAUSE OF THE EVENT IS USER ERROR IN NOT CLEANING THE ERF EVAPORATION COVER AFTER SPILLING ERF DURING DAILY MAINTENANCE.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED POSITIVELY BIASED K+ QC RESULTS ON THE VITROS 250 ANALYZER. 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.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *