BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS OP REAGENT

    MDR report key: 6169007 · Received December 13, 2016

    Report

    Report Number
    1319808-2016-00042
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 17, 2016
    Report Date
    December 13, 2016
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DJG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 AND OXYCODONE. ALTHOUGH THERE IS NO INDICATION THAT THE INSTRUMENT WAS NOT PERFORMING AS INTENDED, AN INSTRUMENT ISSUE CANNOT BE COMPLETELY RULED OUT AS A CONTRIBUTING FACTOR TO THE EVENT. THERE IS NO INFORMATION TO SUGGEST THAT THE VITROS OP REAGENT MALFUNCTIONED.

    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: 279 NG/ML (POSITIVE CUTOFF >OR = 300 NG/ML) VS. >POSITIVE (2500 NG/ML OXYCODONE AND 620 NG/ML OXYMORPHONE). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE DISCORDANT VITROS OP-LO RESULT WAS REPORTED OUT OF THE LABORATORY. HOWEVER, 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. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819988 VITROS CHEMISTRY PRODUCTS OP REAGENT IN VITRO DIAGNOSTIC DJG ORTHO-CLINICAL DIAGNOSTICS 1527-09-5274

    Patients

    Seq Age Sex Outcome Treatment
    1