BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS BENZ REAGENT

    MDR report key: 1631970 · Received February 5, 2010

    Report

    Report Number
    1319808-2010-00002
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    December 24, 2009
    Report Date
    January 8, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JXM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 IF A COMBINATION OF A KNOWN LIMITATION OF THE VITROS BENZ REAGENT RELATED TO LOW CROSS REACTIVITY WITH LORAZEPAM GLUCURONIDE AND USE ERROR IN THE INTERPRETATION OF A VITROS BENZ RESULT. CONFIRMATORY TESTING CONCLUDES THAT THE VITROS BENZ METHOD IDENTIFIED A BENZODIAZEPINE COMPOUND AT A MUCH LOWER CONCENTRATION THAN GC/MS. 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 PROVIDED ONLY A PRELIMINARY TEST RESULT. A MORE SPECIFIC ALTERNATIVE CHEMICAL METHOD MUST BE USED TO CONFIRM A RESULT OBTAINED WITH VITROS BENZ ASSAY. GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GC/MS) IS THE PREFERRED CONFIRMATORY METHOD. CLINICAL CONSIDERATION AND PROFESSIONAL JUDGEMENT SHOULD BE APPLIED TO ANY DRUG-OF-ABUSE TEST RESULT. NO MALFUNCTION OF THE VITROS BENZ REAGENT OCCURRED. THERE WAS NO ALLEGATION OF PT HARM AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED FALSE NEGATIVE VITROS BENZ RESULT ON ONE PT 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. THE ORIGINAL AFFECTED RESULT WAS REPORTED TO THE CLINICIAN, AND A CORRECTED REPORT WAS LATER ISSUED. THERE WAS NO REPORT OF HARM TO THE PT 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 NA 1523-07-9075

    Patients

    Seq Age Sex Outcome Treatment
    1