BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS E170 PSA REAGENT

    MDR report key: 1780411 · Received September 14, 2007

    Report

    Report Number
    1823260-2007-08061
    Event Type
    Malfunction
    Date Received
    September 14, 2007
    Date of Event
    August 20, 2007
    Report Date
    September 14, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT SAMPLE WITH A POTENTIAL INTERFERENT CAUSING FALSELY LOW PSA RESULTS. THE SAMPLE GAVE A RESULT OF <0.1 NG/ML. THE SAMPLE WAS THEN MIXED WITH A KNOWN POSITIVE SAMPLE WITH A VALUE OF 140 NG/ML. THE RESULT OF THIS MIXED SAMPLE WAS ALSO <0.1 NG/ML. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYTICS E170 PSA REAGENT IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS E170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA ZOLADEX