BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS OP REAGENT

    MDR report key: 5084841 · Received September 17, 2015

    Report

    Report Number
    1319808-2015-00017
    Event Type
    Malfunction
    Date Received
    September 17, 2015
    Date of Event
    August 13, 2015
    Report Date
    September 17, 2015
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DJG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A DISCORDANT, NEGATIVE VITROS OP-LO RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE RUN ON THE VITROS 5600 INTEGRATED SYSTEM. THE INTENDED USE SECTION OF THE VITROS OP IFU STATES THAT THE VITROS CHEMISTRY PRODUCT OP 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 OP ASSAY. GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GCMS) IS THE PREFERRED CONFIRMATORY METHOD. CLINICAL CONSIDERATION AND PROFESSIONAL JUDGMENT SHOULD BE APPLIED TO ANY DRUG-OF-ABUSE TEST RESULT. THE LIKELY CAUSE IS A KNOWN LIMITATION OF THE VITROS OP REAGENT RELATED TO LOW CROSS REACTIVITY WITH OXYMORPHONE. THERE IS NO EVIDENCE THAT AN INSTRUMENT ISSUE CONTRIBUTED TO THE EVENT. THE CUSTOMER¿S CALIBRATION OF THE VITROS OP-LO REAGENT IN USE AT THE TIME OR AN UNIDENTIFIED REAGENT ISSUE COULD NOT BE RULED OUT AS CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A DISCORDANT, NEGATIVE VITROS OP-LO RESULT FROM A SINGLE PATIENT SAMPLE RUN ON THE VITROS 5600 INTEGRATED SYSTEM, WHEN COMPARED TO A POSITIVE OPIATE RESULT OBTAINED USING THE GC/MS METHOD. VITROS PATIENT RESULT: 277 NG/ML (POSITIVE CUTOFF >OR = 300 NG/ML) VS. >12000 NG/ML (POSITIVE). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. IT IS NOT KNOWN IF THE DISCORDANT VITROS OP-LO RESULT WAS REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF TREATMENT STARTED, STOPPED, OR ALTERED BASED ON THE FALSE NEGATIVE VITROS OP-LO RESULT AND 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
    616882 VITROS CHEMISTRY PRODUCTS OP REAGENT IN-VITROS DIAGNOSTIC DJG ORTHO-CLINICAL DIAGNOSTICS 1527-09-4374

    Patients

    Seq Age Sex Outcome Treatment
    1