BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2010 RACK ELECSYS

    MDR report key: 1336690 · Received March 10, 2009

    Report

    Report Number
    1823260-2007-05211
    Event Type
    Malfunction
    Date Received
    March 10, 2009
    Date of Event
    May 26, 2007
    Report Date
    June 14, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INITIAL ICG RESULT <5.0 (0.963) MLU/ML. SAME SAMPLE REPEATED GAVE RESULTS OF 41180 AND 41561 MLU/ML. THE INITIAL RESULT WAS REPORTED. NO INFORMATION PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2010 RACK ELECSYS IMMUNO CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 2010 RACK

    Patients

    Seq Age Sex Outcome Treatment
    1