BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS IMMUNO-WASH FLUID

    MDR report key: 1360473 · Received March 25, 2009

    Report

    Report Number
    1319808-2009-00074
    Event Type
    Malfunction
    Date Received
    March 25, 2009
    Date of Event
    February 25, 2009
    Report Date
    February 25, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THE VITROS PHBR ASSAY AND THE VITROS 5,1 WERE OPERATING AS INTENDED. THE INVESTIGATION DETERMINED THAT THE CUSTOMER WAS NOT REPLACING THE VITROS IMMUNO-WASH FLUID (IWF) EVERY 72 HOURS PER THE MANUFACTURER'S RECOMMENDATIONS. THE IWF INSTRUCTIONS FOR USE INDICATE THAT THE IWF RESERVOIR AND ANY REMAINING FLUID SHOULD BE DISCARDED AFTER 3 DAYS. THE CUSTOMER HAS OBSERVED STABLE PERFORMANCE SINCE IMPLEMENTING THE MANUFACTURER'S RECOMMENDATIONS FOR IWF HANDLING.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED IMPRECISE QUALITY CONTROL RESULTS USING VITROS PHBR SLIDES ON A VITROS 5,1 FS CHEMISTRY ANALYZER. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. PATIENT RESULTS WERE NOT REPORTED UNLESS QUALITY CONTROL WAS ACCEPTABLE. THERE WERE NO ALLEGATIONS OF HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS IMMUNO-WASH FLUID IN VITRO DIAGNOSTIC JJE ORTHO-CLINICAL DIAGNOSTICS NA P8403

    Patients

    Seq Age Sex Outcome Treatment
    1