BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1012730 · Received March 12, 2008

    Report

    Report Number
    1823260-2008-02372
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 19, 2008
    Report Date
    March 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE POOLED PATIENT SAMPLE WITH DISCREPANT PROSTATE SPECIFIC ANTIGEN RESULTS. INITIAL RESULT IS 40 UG/L, REPEATED TWICE GAVE 22 UG/L (SAME METHODOLOGY) AND 22 UG/L (DIFFERENT METHODOLOGY). RESULT WAS NOT REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK