BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS BENZ REAGENT

    MDR report key: 3124956 · Received May 22, 2013

    Report

    Report Number
    1319808-2013-00031
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 18, 2013
    Report Date
    May 22, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JXM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NEGATIVE VITROS BENZ RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. 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. THE MOST LIKELY CAUSE IS A KNOWN LIMITATION OF THE VITROS BENZ REAGENT RELATED TO LOW CROSS REACTIVITY WITH LORAZEPAM. THERE IS NO EVIDENCE THAT A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THIS CUSTOMER OBSERVED A DISCORDANT, NEGATIVE VITROS BENZ RESULT (<85 (NEGATIVE) VS. AN EXPECTED RESULT = 1015 NG/ML (POSITIVE)) FROM A SINGLE PATIENT SAMPLE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. THE AFFECTED RESULT WAS REPORTED OUT OF THE LABORATORY. BIASED PATIENT RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE PHYSICIAN QUESTIONED THE RESULT AS A POSITIVE TEST RESULT WAS EXPECTED. THE SAMPLE WAS SENT FOR CONFIRMATORY TESTING USING A GC/MS METHOD. A CORRECTED REPORT WAS ISSUED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226809 VITROS CHEMISTRY PRODUCTS BENZ REAGENT IN VITRO DIAGNOSTIC JXM ORTHO-CLINICAL DIAGNOSTICS 1523-15-2524

    Patients

    Seq Age Sex Outcome Treatment
    1