BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT

    MDR report key: 3934766 · Received July 15, 2014

    Report

    Report Number
    3007111389-2014-00157
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 14, 2014
    Report Date
    July 15, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPI ES RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. 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. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE OVERALL INTEGRITY OF THE SAMPLE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS TROPI ES RESULT ON A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. VITROS TROPI ES RESULT OF 1.190 NG/ML VS. EXPECTED RESULT OF <0.012 NG/ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE NON-REPRODUCIBLE, FALSELY ELEVATED TROPI ES RESULT WAS REPORTED OUTSIDE THE LABORATORY, HOWEVER; NO TREATMENT WAS GIVEN, CHANGED, OR WITHHELD BASED ON THE REPORTED TROPI ES RESULT. THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413832 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1460

    Patients

    Seq Age Sex Outcome Treatment
    1