BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2010 RACK ELECSYS

    MDR report key: 1762395 · Received July 6, 2007

    Report

    Report Number
    1823260-2007-05889
    Event Type
    Malfunction
    Date Received
    July 6, 2007
    Date of Event
    April 15, 2007
    Report Date
    July 6, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DISCREPANT ESTRADIOL RESULTS WHEN COMPARING 2 METHODS. THE RESULTS USING THE INITIAL METHOD ALSO DO NOT CORRELATE WITH THE CLINICAL CONDITION AND ULTRASOUND REPORTS OF THE PATIENTS. THE FOLLOWING PATIENT EXAMPLES WERE PROVIDED, UNITS OF MEASURE PMOL/L, SAMPLE RESULTS LISTED AS INITIAL/REPEAT: 2200/1710; 3300/2198; 5300/4348; 1900/1618; 2200/1871; 7200/6070; 900/800; 17000/12514; 7900/6205; 16000/12551; 5900/4000; 2900/2047; 10800/9310; 6700/7600; 22300/13450; 8400/6664; 14000/10448; 26000/17249; 14700/7160; 7100/5864; 9700/8338/24000/14250; 10100/7784;13000/10547; 12000/9600; 40000/22000; 18000/14000; 28000/9000; 59000/37000; 6200/4400. ONE ADDITIONAL SAMPLE WAS TESTED ON 2 SEPARATE DAYS, INITIAL RESULT, 1ST DAY 9200, REPEAT 5800. SAME SAMPLE REPEATED ON DIFFERENT DAY RECOVERED 9471, REPEAT 6774. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    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 UNK