BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROP I ES REAGENT PACK

    MDR report key: 1020253 · Received March 26, 2008

    Report

    Report Number
    9680658-2008-00084
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 27, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THE VITROS ECI WAS OPERATING AS INTENDED. THE ROOT CAUSE FOR THE UNEXPECTED TROP I ES RESULT IS UNK. IT IS LIKELY THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE ORIGINAL SAMPLE THAT WAS NO LONGER PRESENT WHEN THE SAMPLE WAS REPEATED, HOWEVER, THIS COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED FALSE POSITIVE VITROS TROP I ES OUTLIER ON A PATIENT SAMPLE. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE INITIAL TROP I ES PATIENT RESULT WAS REPORTED TO THE CLINICIAN, HOWEVER, THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS TROP I ES REAGENT PACK IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS NA 0060

    Patients

    Seq Age Sex Outcome Treatment
    1