BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS BENZ REAGENT

    MDR report key: 1868543 · Received October 13, 2010

    Report

    Report Number
    1319808-2010-00018
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    September 7, 2010
    Report Date
    October 13, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JXM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT CONCLUDED THAT FALSE NEGATIVE BENZ RESULTS OCCURRED ON SAMPLES FROM ONE PATIENT. THE MOST LIKELY CAUSE IS A KNOWN LIMITATION OF THE VITROS BENZ REAGENT RELATED TO LOW CROSS REACTIVITY WITH LORAZEPAM. 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

    THIS CUSTOMER OBSERVED FALSE NEGATIVE VITROS BENZ RESULTS ON SAMPLES FROM THE SAME PATIENT USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED PATIENT RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE RESULTS WERE REPORTED FROM THE LABORATORY. CORRECTED REPORTS WERE ISSUED THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. 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

    Patients

    Seq Age Sex Outcome Treatment
    1