BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 3900576 · Received June 27, 2014

    Report

    Report Number
    3007111389-2014-00140
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, FALSELY ELEVATED VITROS TROPI ES RESULT WAS OBTAINED FROM A PATIENT SAMPLE PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. THERE WAS NO INDICATION THAT A REAGENT OR INSTRUMENT 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 ASSIGNABLE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS TROPI ES RESULT FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. VITROS TROPI ES RESULT =0.233 NG/ML VS. EXPECTED < 0.012 NG/ML. A BIASED RESULT OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THE HIGHER THAN EXPECTED VITROS TROPI ES RESULT WAS REPORTED FROM THE LABORATORY. HOWEVER, A CORRECTED REPORT WAS LATER ISSUED BASED ON REPEAT TESTING OF THE SAMPLE AND 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
    377317 VITROS IMMUNODIAGNOSTICS PRODUCTS TROPONIN I ES REAGENT PACK IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1380

    Patients

    Seq Age Sex Outcome Treatment
    1