BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT

    MDR report key: 2220809 · Received August 23, 2011

    Report

    Report Number
    3007111389-2011-00114
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 22, 2011
    Report Date
    August 23, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LTJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT DISCORDANT, LOWER THAN EXPECTED, VITROS PSA RESULTS OCCURRED ON TWO DIFFERENT PATIENT SAMPLES COLLECTED FROM THE SAME PATIENT, WHEN COMPARED TO AN ALTERNATIVE METHOD PSA RESULT. THE MOST LIKELY ASSIGNABLE CAUSE COULD NOT BE DETERMINED; HOWEVER, AN UNKNOWN SAMPLE INTERFERENT THAT AFFECTS THE VITROS PSA ASSAY COULD NOT BE RULED OUT AS HAVING CONTRIBUTED TO THE EVENT. THE ISSUE APPEARS TO BE PATIENT RELATED, NOT SAMPLE RELATED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED DISCORDANT, LOWER THAN EXPECTED, VITROS PSA RESULTS (4.70, 4.88, 9.18 NG/ML) FROM TWO DIFFERENT SAMPLES COLLECTED FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THE VITROS RESULTS WERE COMPARED TO A PSA RESULT OBTAINED FROM ONE OF THE TWO SAMPLES TESTED ON A NON-VITROS SYSTEM (14.33 NG/ML). THE ALTERNATIVE METHOD PSA RESULT WAS BELIEVED TO BE THE ACCURATE RESULT. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE LOWER THAN EXPECTED VITROS PSA PATIENT RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO REPORT 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
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT IN-VITRO DIAGNOSTIC LTJ ORTHO-CLINICAL DIAGNOSTICS 2750

    Patients

    Seq Age Sex Outcome Treatment
    1