BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS BENZ REAGENT

    MDR report key: 1695522 · Received May 21, 2010

    Report

    Report Number
    1319808-2010-00011
    Event Type
    Malfunction
    Date Received
    May 21, 2010
    Date of Event
    March 12, 2010
    Report Date
    May 21, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JXM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT CONCLUDED THAT A FALSE NEGATIVE BENZ RESULT OCCURRED. THE MOST LIKELY CAUSE IS A COMBINATION OF A KNOWN LIMITATION OF THE VITROS BENZ REAGENT RELATED TO LOW CROSS REACTIVITY WITH LORAZEPAM AND USE ERROR IN THE INTERPRETATION OF A VITROS BENZ RESULT. THE PROFICIENCY SAMPLE CONTAINED LORAZEPAM AND AT TARGET CONCENTRATION OF 1000 NG/ML AND THE VITROS BENZ REAGENT IDENTIFIED A BENZODIAZEPINE COMPOUND AT A MUCH LOWER CONCENTRATION OF 260 NG/ML. THE INTENDED USE SECTION OF THE VITROS BENZ IFU STATES THAT THE VITROS CHEMISTRY PRODUCT BENZ ASSAY IS INTENDED FOR USE BY PROFESSIONAL LABORATORY PERSONNEL. IT PROVIDES ONLY A PRELIMINARY TEST RESULT. A MORE SPECIFIC ALTERNATIVE CHEMICAL METHOD MUST BE USED TO CONFIRM A RESULT OBTAINED WITH THE VITROS BENZ ASSAY. GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GC/MS) IS THE PREFERRED CONFIRMATORY METHOD. CLINICAL CONSIDERATION AND PROFESSIONAL JUDGMENT SHOULD BE APPLIED TO ANY DRUG-OF-ABUSE TEST RESULT. NO MALFUNCTION OF THE VITROS BENZ REAGENT OCCURRED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    A FALSE NEGATIVE VITROS BENZ RESULT WAS OBTAINED FROM A PROFICIENCY SAMPLE WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. THE MAGNITUDE AND DIRECTION OF THE FALSE NEGATIVE VITROS BENZ RESULT OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF IT OCCURRED ON A PATIENT SAMPLE. PATIENT SAMPLES WERE NOT AFFECTED AND THERE WAS NO ALLEGATION OF PATIENT HARM. 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 BENZ REAGENT IN-VITRO DIAGNOSTIC JXM ORTHO-CLINICAL DIAGNOSTICS 1523-09-9381

    Patients

    Seq Age Sex Outcome Treatment
    1