BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1000539 · Received February 15, 2008

    Report

    Report Number
    1823260-2008-01598
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 21, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PT SAMPLE WITH DISCREPANT ESTRADIOL RESULTS. INITIAL RESULT GAVE 5.28 PG/ML; REPEAT GAVE 1937 PG/ML. THE INVESTIGATIONAL UNIT WAS UNABLE TO DETERMINE THE SPECIFIC ROOT CAUSE OF THE COMPLAINT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK