BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2010 RACK ELECSYS

    MDR report key: 1780192 · Received September 21, 2007

    Report

    Report Number
    1823260-2007-08262
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Date of Event
    August 30, 2007
    Report Date
    September 21, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PT SAMPLE WITH INITIAL PSA RESULT 0.02 NG/ML. SAME SAMPLE REPEATED GAVE RESULT OF 3.0 NG/ML. INITIAL RESULT WAS REPORTED, PT NOT ADVERSELY AFFECTED. THE FIELD SERVICE REP DETERMINED THERE WAS A PROBLEM WITH THE PROBE ALIGNMENT. THE INSTRUMENT WAS REPAIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA