BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCT CKMB REAGENT

    MDR report key: 3943404 · Received July 18, 2014

    Report

    Report Number
    3007111389-2014-00160
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 18, 2014
    Report Date
    July 18, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JHX
    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, HIGHER THAN EXPECTED VITROS CKMB RESULT WAS OBTAINED FROM A PATIENT SAMPLE PROCESSED ON THE VITROS 5600 SYSTEM. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. THERE WAS NO INDICATION THE VITROS 5600 SYSTEM OR THE VITROS CKMB REAGENT CONTRIBUTED TO THE EVENT. ADDITIONALLY, IT IS UNKNOWN IF THE SAMPLE WAS PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER¿S RECOMMENDATIONS. IT IS POSSIBLE 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, HIGHER THAN EXPECTED VITROS CKMB RESULT FROM A PATIENT SAMPLE PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. A VITROS CKMB RESULT OF 25.6 NG/ML VS. EXPECTED RESULT OF 0.54 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, HIGHER THAN EXPECTED CKMB RESULT WAS REPORTED FROM THE LABORATORY, HOWEVER, A CORRECTED REPORT WAS ISSUED AND NO TREATMENT WAS GIVEN, CHANGED, OR WITHHELD BASED ON THE REPORTED CKMB RESULT REPORTED. THERE WAS NO ALLEGATION OF PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422394 VITROS IMMUNODIAGNOSTICS PRODUCT CKMB REAGENT IN-VITRO DIAGNOSTIC JHX ORTHO-CLINICAL DIAGNOSTICS 1670

    Patients

    Seq Age Sex Outcome Treatment
    1