BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS CHEMISTRY PRODUCTS AMPH REAGENT

    MDR report key: 1565004 · Received December 22, 2009

    Report

    Report Number
    1319808-2009-00412
    Event Type
    Injury
    Date Received
    December 22, 2009
    Date of Event
    October 7, 2009
    Report Date
    December 3, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROFICIENCY REPORT FOR THE SAMPLE INDICATED THAT THE SAMPLE CONTAINED METHYLENEDIOXY - METHAMPHETAMINE (MDMA). THE MDMA CONCENTRATION IN THE SAMPLE WAS GREATER THAN THE LAB CUTOFF OF 1000 NG/ML, AND WAS THEREFORE CONSIDERED TO BE POSITIVE FOR AMPHETAMINES. THE ANALYTICAL SPECIFICITY SECTION OF THE VITROS AMPH IFU STATES THAT THE VITROS AMPH HAS A LOW CROSS-REACTIVITY WITH MDMA. THE LOW CROSS-REACTIVITY IS THE CAUSE OF THE FALSE NEGATIVE PROFICIENCY FLUID RESULTS FOR THE SAMPLE. THE INTENDED USE SECTION OF THE VITROS AMPH IFU, ALSO STATES THAT THE VITROS CHEMISTRY PRODUCTS AMPH ASSAY PROVIDE ONLY A PRELIMINARY TEST RESULT. A MORE SPECIFIC ALTERNATIVE CHEMICAL METHOD MUST BE USED TO CONFIRM RESULTS OBTAINED WITH THIS 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, PARTICULARLY WHEN EVALUATING A PRELIMINARY POSITIVE RESULT. THE ROOT CAUSE OF THIS EVENT IS A KNOWN LIMITATION OF THE VITROS AMPH ASSAY AND USER ERROR IN THE INTERPRETATION OF A POSITIVE VITROS AMPH RESULT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED FALSE NEGATIVE RESULTS FOR A SINGLE PROFICIENCY FLUID SAMPLE PROCESSED USING VITROS AMPH REAGENT ON A VITROS 5,1 FS SYSTEM. THE EXPECTED RESULT FOR THE SAMPLE WAS POSITIVE. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. PT SAMPLES WOULD BE AFFECTED IF THE SAME CIRCUMSTANCE OCCURRED. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS AMPH REAGENT IN-VITRO DIAGNOSTIC DKZ ORTHO-CLINICAL DIAGNOSTICS NA 1521-01-8978

    Patients

    Seq Age Sex Outcome Treatment
    1