BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 DISK IMMUNOCHEMISTRY ANALYZER

    MDR report key: 824771 · Received January 17, 2007

    Report

    Report Number
    1823260-2007-00490
    Event Type
    Malfunction
    Date Received
    January 17, 2007
    Date of Event
    December 19, 2006
    Report Date
    January 17, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INITIAL HGC-BETA RESULT OF 14.11 MUI/ML WAS RERUN ON THE SAME PATIENT TUBE AND RECOVERED <0.100 MUI/ML. NO INFORMATION WAS PROVIDED AS TO WHETHER OR NOT THE INITIAL RESULT WAS USED TO PROVIDE PATIENT TREATMENT. ROOT CAUSE ANALYSIS IS ONGOING. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA