BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1000535 · Received February 15, 2008

    Report

    Report Number
    1823260-2008-01605
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    November 19, 2007
    Report Date
    February 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LTJ
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE PT SAMPLE WITH DISCREPANT TOTAL PSA RESULTS. INITIAL RESULT GAVE 12.03 NG/ML; SAMPLE REPEATED IN 2008 GAVE 52.39 NG/ML. A SECOND SAMPLE FROM THE SAME PT GAVE 52.34 NG/ML. FALSELY LOW RESULTS WERE NOT REPRODUCIBLE UPON RERUN. THE INVESTIGATIONAL UNIT WAS UNABLE TO IDENTIFY A SPECIFIC ROOT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER -JJE LTJ ROCHE DIAGNOSTICS E MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK