BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS OP REAGENT

    MDR report key: 3156885 · Received June 8, 2013

    Report

    Report Number
    1319808-2013-00034
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 15, 2013
    Report Date
    June 7, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DJG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT A CUSTOMER OBTAINED A NON-REPRODUCIBLE, DISCORDANT NEGATIVE VITROS OP-LO RESULT (294 NG/ML (NEGATIVE) VS. AN EXPECTED RESULT > 300 NG/ML (POSITIVE)) FOR A POSITIVE CAP PROFICIENCY SAMPLE RUN ON THE VITROS 5, 1 FS CHEMISTRY. THE INVESTIGATION DETERMINED THAT THE SAMPLE CONTAINED OXYCODONE AT A TARGET CONCENTRATION OF 2000 NG/ML. AS PER THE VITROS OP INSTRUCTIONS FOR USE (IFU), AT THE 300 NG/ML CUTOFF, VITROS OP REAGENT HAS A 15% CROSS REACTIVITY WITH OXYCODONE. IN ADDITION, THE INVESTIGATION DETERMINED THAT THE OP-LO CALIBRATION IN USE AT THE TIME OF THE EVENT WAS NEGATIVELY BIASED. THE MOST LIKELY CAUSE OF THE EVENT WAS A COMBINATION OF A KNOWN LIMITATION OF THE VITROS OP REAGENT RELATED TO LOW CROSS REACTIVITY WITH OXYCODONE AND THE OP-LO CALIBRATION IN USE AT THE TIME OF THE EVENT. THERE WAS NO EVIDENCE THAT AN INSTRUMENT RELATED ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A NON-REPRODUCIBLE, DISCORDANT NEGATIVE VITROS OP-LO RESULT (294(NEGATIVE) VS. AN EXPECTED RESULT > 300 NG/ML (POSITIVE)) FOR A POSITIVE CAP PROFICIENCY SAMPLE RUN ON THE VITROS 5, 1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT THAT PATIENT SAMPLE WERE AFFECTED. 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
    254563 VITROS CHEMISTRY PRODUCTS OP REAGENT IN-VITRO DIAGNOSTIC DJG ORTHO-CLINICAL DIAGNOSTICS 1527-07-2374

    Patients

    Seq Age Sex Outcome Treatment
    1