BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK

    MDR report key: 863355 · Received June 12, 2007

    Report

    Report Number
    2521625-2007-00158
    Event Type
    Malfunction
    Date Received
    June 12, 2007
    Date of Event
    February 15, 2007
    Report Date
    May 15, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTIC
    Product Code
    LTJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT SHOWED THAT THE PROFICIENCY ORGANIZATION INDICATED THAT ALL ECI USERS PARTICIPATING IN THE STUDY YIELDED SIMILAR RESULTS. QC RESULTS WERE ACCEPTABLE ON THE DAY OF TESTING. DATALOGS COULD NOT BE RECOVERED FOR ANALYSIS, AS THE ANALYZER HAS BEEN DE-INSTALLED AT THE CUSTOMER SITE. NO FURTHER TROUBLESHOOTING IS POSSIBLE. THE ROOT CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED NEGATIVELY BIASED PSA RESULTS ON A PROFICIENCY SAMPLE TESTED ON THE ECI ANALYZER. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK IN VITRO DIAGNOSTIC LTJ ORTHO-CLINICAL DIAGNOSTIC NA 1120

    Patients

    Seq Age Sex Outcome Treatment
    1 YR