BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT

    MDR report key: 3884991 · Received June 19, 2014

    Report

    Report Number
    3007111389-2014-00130
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 19, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPI ES RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS UNKNOWN. AN INSTRUMENT ISSUE CANNOT BE RULED OUT. THE CUSTOMER PERFORMED ROUTINE MAINTENANCE TO THE MICROWELL INCUBATOR, AND FOLLOWING THIS ROUTINE MAINTENANCE, ACCEPTABLE VITROS TROPI ES PERFORMANCE WAS OBSERVED. HOWEVER, A PRE-MAINTENANCE VITROS WITHIN-RUN PRECISION TEST WAS NOT PERFORMED; THEREFORE, AN INSTRUMENT RELATED ISSUE CANNOT BE RULED OUT. ADDITIONALLY, A REAGENT ISSUE CANNOT BE RULED OUT, AS THE HISTORICAL QUALITY CONTROL PERFORMANCE WAS NOT PROVIDED UPON REQUEST TO RULE OUT AN UNKNOWN REAGENT ISSUE AS A CONTRIBUTING FACTOR. FINALLY, 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. THE ROOT CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE, HIGHER THAN EXPECTED; VITROS TROPI ES RESULTS FROM TWO DIFFERENT PATIENT SAMPLES PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT 1: 0.767 NG/ML VS.0.019 NG/ML. PATIENT 2: 0.594 NG/ML VS. <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 RESULTS OBTAINED FROM BOTH PATIENT SAMPLES WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM. (B)(4) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361991 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1520

    Patients

    Seq Age Sex Outcome Treatment
    1