BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000 PSA

    MDR report key: 2123327 · Received June 2, 2009

    Report

    Report Number
    2017183-2009-00031
    Event Type
    Other
    Date Received
    June 2, 2009
    Report Date
    May 27, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MTF
    PMA / PMN Number
    P930027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABORATORY INVESTIGATED THE POSSIBILITY OF A HETEROPHILIC ANTIBODY INTERFERENCE IN THE PSA AFTER COMPLETED THERAPY. THE INVESTIGATION CONCLUDED THAT IN THE ABSENCE OF CLINICAL CORRELATION, POSITIVE PSA MONITORING RESULTS SHOULD ALWAYS BE ASSESSED FOR HETEROPHILIC ANTIBODY INTERFERENCE.

    Description of Event or Problem · 1

    CLINICAL BIOCHEM ARTICLE REPORTED PREVIOUS CASE OF MEASUREMENT INVOLVING THE PSA ASSAY. A PATIENT WAS INITIALLY FOUND TO HAVE AN ELEVATED PSA ON SCREENING. HE WAS SUBSEQUENTLY DIAGNOSED WITH GLEASON 7 ADENOCARCINOMA OF THE PROSTATE. POSTOPERATIVELY, SERIAL PSA MEASUREMENTS FOR THE PATIENT WERE UNDETECTABLE FOR NEARLY 3 YEARS. IN (B)(6) 2007, THE PSA ROSE TO 1.4NG/ML AND CONTINUED TO INCREASE OVER THE NEXT 3 MONTHS. THE PATIENT WAS TREATED WITH HORMONAL THERAPY, SYSTEMIC CHEMOTHERAPY AND PELVIC RADIATION. DURING THE THERAPY, THE RESULTS DECLINED BRIEFLY ON TWO OCCASIONS BUT STILL REMAINED HIGH. INVESTIGATION STUDY OF PATIENT SAMPLES WERE SENT TO REFERRAL LABORATORIES USING TWO DIFFERENT ALTERNATIVE INSTRUMENTS WITH EACH ASSAYS RETURNED LOW RESULT. ACCORDING TO THE REPORT, PATIENT RESULT WAS REPORTED AND TREATED BASED ON THE DISCORDANT ELEVATED PSA ASSAY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 PSA PSA IMMUNOASSAY MTF SIEMENS HEALTHCARE DIAGNOSTICS INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other