BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTROS CHEMISTRY PRODUCTS BENZ REAGENT PACK

    MDR report key: 1509296 · Received May 28, 2009

    Report

    Report Number
    1319808-2008-00158
    Event Type
    Malfunction
    Date Received
    May 28, 2009
    Date of Event
    March 25, 2009
    Report Date
    April 29, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JXM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT FOUND THAT THE VITROS 5,1 AND VITROS BENZ REAGENT PERFORMED AS INTENDED. CONFIRMATORY TESTING WITH GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GC/MS) INDICATED THAT THE PATIENT SAMPLE CONTAINED OXAZEPAM. BOTH THE VITROS BENZ METHOD AND THE COMPETITIVE METHOD USED IN THE CORRELATION TESTING IDENTIFIED A BENZODIAZEPINE COMPOUND AT A MUCH LOWER CONCENTRATION THAN GC/MS. THIS DATA INDICATES THAT BOTH METHODS UNDER RECOVERED THE QUANTITY OF BENZODIAZEPINES IN THE PATIENT SAMPLE. THE VITROS BENZ IFU INDICATES THAT REFERENCE METHODS HYDROLYZE BENZODIAZINE GLUCURONIDES IN THE EXTRACTION PROCESS, INCREASING THE RECOVERY OF BENZODIAZEPINES BY THE REFERENCE METHOD AS COMPARED TO THE VITROS BENZ ASSAY. THE MOST LIKELY ROOT CAUSE FOR THE FALSE NEGATIVE VITROS BENZ RESULT IS THAT THE PATIENT SAMPLE CONTAINED OXAZEPAM GLUCURONIDE WHICH IS ALMOST UNDETECTABLE BY THE VITROS BENZ REAGENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A FALSE NEGATIVE PATIENT RESULT DURING A PATIENT CORRELATION TEST USING VITROS BENZ REAGENT ON THE VITROS 5,1 FS CHEMISTRY SYSTEM. CONFIRMATORY TESTING WITH GC/MS INDICATED THE PRESENCE OF OXAZEPAM, A BENZODIAZEPINE COMPOUND. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE FALSE NEGATIVE RESULT WAS NOT REPORTED AS THE SAMPLE WAS PROCESSED FOR CORRELATION TESTING ONLY. 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 VIRTROS CHEMISTRY PRODUCTS BENZ REAGENT PACK IN-VITRO DIAGNOSTIC JXM ORTHO-CLINICAL DIAGNOSTICS NA 1523-05-8672

    Patients

    Seq Age Sex Outcome Treatment
    1