BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS TROPI ES REAGENT PACK

    MDR report key: 4131302 · Received October 1, 2014

    Report

    Report Number
    3007111389-2014-00214
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 2, 2014
    Report Date
    October 1, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT A NON-REPRODUCIBLE AND HIGHER THAN EXPECTED VITROS TROP I ES RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS 5600 SYSTEM. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. AN INSTRUMENT ISSUE WAS NOT LIKELY TO BE A CONTRIBUTING FACTOR. A REAGENT PERFORMANCE ISSUE WAS NOT LIKELY TO BE A CONTRIBUTING FACTOR. PRE-ANALYTICAL SAMPLE HANDLING CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE AND HIGHER THAN EXPECTED VITROS TROPI ES RESULT FROM A SINGLE PATIENT SAMPLE PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. VITROS TROPONIN I ES RESULT OF 2.86 NG/ML VS. EXPECTED RESULT OF <0.012 NG/ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF OCCURRED UNDETECTED. THERE ARE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THE HIGHER THAN EXPECTED VITROS TROPI ES RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610552 VITROS IMMUNODIAGNOSTICS PRODUCTS TROPI ES REAGENT PACK IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1591

    Patients

    Seq Age Sex Outcome Treatment
    1