BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 DISK

    MDR report key: 1770750 · Received September 5, 2007

    Report

    Report Number
    1823260-2007-07768
    Event Type
    Malfunction
    Date Received
    September 5, 2007
    Date of Event
    August 22, 2007
    Report Date
    September 5, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INITIAL CK MB RESULT <0.1 NG/ML. SAME SAMPLE REPEATED GAVE RESULT OF AROUND 2 OR 3 NG/ML, EXACT RESULT NOT PROVIDED. THE INITIAL RESULT WAS NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANCY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA