BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1083180 · Received July 24, 2008

    Report

    Report Number
    1823260-2008-05775
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO PATIENTS WITH DISCREPANT MYOGLOBIN RESULTS. PATIENT 1, INITIAL RESULT <21.00 NG/ML, REPEAT 46.56 NG/ML. INITIAL RESULT WAS REPORTED FOR PATIENT 1 ONLY, THE PATIENT WAS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE THE ROOT CAUSE, BUT NOTED HE PERFORMED MAINTENANCE ON THE SAMPLE FLOWPATH AND SIPPER FLOW PATH. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 2

    TWO PATIENTS WITH DISCREPANT MYOGLOBIN RESULTS. PATIENT 2, INITIAL RESULT <21.00 NG/ML, REPEATED TWICE GAVE <21.00 AND 53.61 NG/ML. INITIAL RESULT WAS REPORTED FOR PATIENT 1 ONLY, THE PATIENT WAS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE THE ROOT CAUSE BUT NOTED HE PERFORMED MAINTENANCE ON THE SAMPLE FLOWPATH AND SIPPER FLOW PATH. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

    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 UNK
    2 UNK