BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT

    MDR report key: 2151753 · Received July 6, 2011

    Report

    Report Number
    3007111389-2011-00091
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    May 19, 2011
    Report Date
    July 6, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, FALSELY ELEVATED, TROP I ES RESULT OCCURRED ON A SINGLE PATIENT SAMPLE PROCESSED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE COULD NOT BE DETERMINED, HOWEVER THE EFFECT OF SAMPLE PROCESSING COULD NOT BE RULED OUT AS HAVING CONTRIBUTED TO THE EVENT. THE INVESTIGATION DETERMINED THAT THE CUSTOMER HAD PROCESSED THE PATIENT SAMPLE OUTSIDE THE SAMPLE COLLECTION TUBE MANUFACTURER'S RECOMMENDATIONS FOR CENTRIFUGATION TIME AND SPEED. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. THERE WAS NO EVIDENCE TO SUGGEST THAT THE VITROS ECI SYSTEM OR THE TROPI ES REAGENT MALFUNCTIONED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED; VITROS TROPI ES RESULT (0.066 NG/ML) FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE SAME SAMPLE WAS RETESTED AND THE REPEAT RESULT (REPEAT 0.012, 0.013, 0.012 NG/ML) WAS BELIEVED TO BE THE ACCURATE RESULT. THE HIGHER THAN EXPECTED PATIENT RESULT WAS REPORTED OUTSIDE OF THE LABORATORY, HOWEVER, A CORRECTED REPORT WAS SENT TO THE PHYSICIAN AND THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 0610

    Patients

    Seq Age Sex Outcome Treatment
    1