BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 DISK

    MDR report key: 1870058 · Received October 15, 2010

    Report

    Report Number
    1823260-2010-06156
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 22, 2010
    Report Date
    October 28, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SYSTEM SPECIFIC ISSUE WAS NOT IDENTIFIED. INFORMATION PROVIDED FOR INVESTIGATION IDENTIFIED NO ISSUES WITH THE INSTRUMENT, CALIBRATION, OR CONTROLS. THE PATIENT SAMPLE WAS NOT AVAILABLE FOR FURTHER INVESTIGATION. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE HIGH RESULT FOR CARCINOEMBRYONIC ANTIGEN (CEA) ON THE ELECSYS 2010 DISK ANALYZER, FOR ONE PATIENT SAMPLE. THE INITIAL RESULT FOR CEA GAVE 8.4 NG/ML. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE DOCTORS QUESTIONED THIS RESULT BECAUSE PREVIOUS CEA RESULTS FOR THIS PATIENT WERE "NORMAL". THE ORIGINAL SAMPLE WAS SENT OUT TO ANOTHER FACILITY FOR TESTING WHICH ALSO USES THE SAME ELESYS CEA APPLICATION AND YIELDED THE SAME CEA RESULT OF 8.4 NG/ML. THE SAME SAMPLE WAS SENT OUT TO TWO ADDITIONAL LABORATORIES FOR TESTING. ONE LABORATORY RAN THE SAMPLE ON (B)(6) 2010 ON A BAYER CENTAUR ANALYZER WHICH YIELDED A CEA RESULT OF 2.2 NG/ML. THE OTHER LABORATORY RAN THE SAMPLE ON (B)(6) 2010 USING AN UNKNOWN METHOD, (PAGONIS) OF CHEMILUMINECENCE, WHICH YIELDED A CEA RESULT OF 3.5 NG/ML. THE CEA REAGENT LOT NUMBER WAS 15735101. NO ADVERSE EVENT HAS BEEN ALLEGED REGARDING THIS EVENT.

    Description of Event or Problem · 1

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    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 070 YR