BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCT TROPI ES REAGENT

    MDR report key: 4033325 · Received August 25, 2014

    Report

    Report Number
    3007111389-2014-00191
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 25, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT A NON-REPRODUCIBLE, FALSELY ELEVATED VITROS TROP I ES RESULT WAS OBTAINED FROM A PATIENT SAMPLE PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. THERE WAS NO EVIDENCE TO SUGGEST THAT AN INSTRUMENT OR A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT. ADDITIONALLY, THE SAMPLE WAS NOT PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER¿S RECOMMENDATIONS. IT IS LIKELY THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A SINGLE NON-REPRODUCIBLE, FALSELY ELEVATED VITROS TROPI ES RESULT FROM A PATIENT SAMPLE PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. VITROS TROPI ES RESULT OF 0.338 NG/ML VS. EXPECTED RESULT OF <0.012 NG/ML WAS OBTAINED FROM THE SAMPLE. A BIASED RESULT OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THE NON-REPRODUCIBLE, FALSELY ELEVATED TROPI ES RESULT WAS REPORTED FROM THE LABORATORY, HOWEVER; A CORRECTED REPORT WAS ISSUED AND THERE WAS NO ALLEGATION PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512847 VITROS IMMUNODIAGNOSTICS PRODUCT TROPI ES REAGENT IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1520

    Patients

    Seq Age Sex Outcome Treatment
    1