BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1003487 · Received February 21, 2008

    Report

    Report Number
    1823260-2008-01752
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 24, 2008
    Report Date
    February 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE PT SAMPLE WITH DISCREPANT PTH RESULTS. INITIAL RESULT 16.68 PG/ML. SAME SAMPLE REPEATED TWICE THE NEXT DAY USING A DIFFERENT ANALYZER, SAME METHODOLOGY, GAVE RESULTS OF 171.1 AND 146.4 PG/ML. INITIAL RESULT WAS REPORTED, PT NOT ADVERSELY AFFECTED. THE FIELD SVC REP WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANCY. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPEC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR