BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 250 CHEMISTRY SYSTEM

    MDR report key: 1021617 · Received March 25, 2008

    Report

    Report Number
    1319681-2008-00078
    Event Type
    Malfunction
    Date Received
    March 25, 2008
    Date of Event
    February 12, 2007
    Report Date
    February 25, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT DETERMINED THAT THE CUSTOMER EXPERIENCED IMPRECISE AMMONIA QC RESULTS AFTER THE LABORATORY FLOOR HAD BEEN CLEANED WITH AN AMMONIA BASED PRODUCT. THE USER DOCUMENTATION FOR THE VITROS 250 CHEMISTRY SYSTEM INDICATES "NEVER USE AMMONIA BASED CLEANERS ON OR NEAR THE SYSTEM." USER ERROR IS THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED IMPRECISE AMMONIA QUALITY CONTROL RESULTS ON THE VITROS 250 ANALYZER. NO PT RESULTS WERE REPORTED IF QUALITY CONTROL RESULTS WERE UNACCEPTABLE. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1