BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAGNOSTIC PRODUCT CORP

    MDR report key: 678619 · Received January 23, 2006

    Report

    Report Number
    MW1037863
    Event Type
    Malfunction
    Date Received
    January 23, 2006
    Date of Event
    January 5, 2006
    Report Date
    January 23, 2006
    Manufacturer
    *
    Product Code
    JJQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PSA KIT FROM DPC - DIAGNOSTIC PRODUCTS CORP- WAS NOT ABLE TO PICK UP LOW END PSA RESULTS. THIS IS A PROBLEM FOR UROLOGIST TRYING TO DECIDE IF PROSTATE CANCER HAS RECURRED IN RADICAL PROSTATECTOMIES. THIS INFO MAY ALSO AFFECT IF FURTHER TREATMENTS WILL BE GIVEN TO THE PT, SUCH AS RADIATION OR ANDROGEN DEPRIVATION THERAPY. THE CO SEEMS UNAWARE OF THE PROBLEM AND RPTR DOESN'T BELIEVE THEY GRASP THE SERIOUSNESS OF THIS PROBLEM, AS IT ONLY AFFECTS A SMALL POPULATION OF PTS. THEY HAVE NOT GIVEN RPTR AN ALTERNATIVE TO RESOLVE THIS ISSUE NOR A TIMELINE WHEN THEY CAN EXPECT A RESOLUTION TO THIS EVENT. THIS HAS CAUSED UNDUE STRESS FOR THESE CANCER PTS AS WELL THE CLINICAL STAFF THAT PROVIDES FOLLOW-UP CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAGNOSTIC PRODUCT CORP IMMULITE PSA JJQ * IMMULITE 235
    2 DIAGNOSTIC PRODUCTS CORPORATION IMMULITE PSA JJQ * IMMULITE 236

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other