BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 DISK

    MDR report key: 1061934 · Received June 16, 2008

    Report

    Report Number
    1823260-2008-04751
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 4, 2008
    Report Date
    June 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THREE PATIENTS SAMPLES WITH DISCREPANT ESTRADIOL RESULTS. PATIENT 1, TESTED 2008, INITIAL RESULT <5.00 PG/ML, REPEAT 516.8 PG/ML. PATIENT 2, TESTED ABOUT 9 DAYS LATER, INITIAL RESULT <5.00 PG/ML, REPEAT 18.94 PG/ML. PATIENT 3 TESTED ABOUT ONE WEEK LATER, INITIAL RESULT <5.00 PG/ML, REPEATED TWICE, GAVE RESULTS OF 79.01 AND 77.09 PG/ML. INITIAL RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH SAMPLE CONTAINER POSITIONING AND REPLACED THE SAME DISK. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    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 UNK