BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS SALICYLATE SLIDES

    MDR report key: 1202457 · Received October 8, 2008

    Report

    Report Number
    1319809-2008-00301
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 12, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    DKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THE NEGATIVELY BIASED SALI PROFICIENCY RESULTS WERE ISOLATED TO THE LAST FIVE SLIDES IN ONE VITROS SALI SLIDE CART. THE ROOT CAUSE COULD NOT BE DETERMINED BUT MAY BE RELATED TO USER ERROR WHEN HANDLING THE SALI SLIDE CART IN QUESTION. A NEW SLIDE FROM THE SAME SALI SLIDE LOT AND FROM AN ALTERNATE SALI SLIDE LOT PRODUCED ACCEPTABLE PROFICIENCY RESULTS.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED NEGATIVELY BIASED PROFICIENCY RESULTS USING VITROS SALI SLIDES ON A VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED ON A PT SPECIMEN MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. NO PT RESULTS WERE AFFECTED AND THERE WERE NO ALLEGATIONS OF PT HARM AS A RESULT OF THIS EVENT. NOTE: THIS FORM 3500A IS TWO OF FIVE MDRS FOR THIS EVENT. FIVE DEVICES WERE INVOLVED. FIVE PROFICIENCY SAMPLES WERE ASSAYED USING A SINGLE SALI SLIDE LOT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS SALICYLATE SLIDES IN-VITRO DIAGNOSTIC DKJ ORTHO-CLINICAL DIAGNOSTICS, INC. NA 2229-0052-6491

    Patients

    Seq Age Sex Outcome Treatment
    1