BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAYER IMMUNO 1 SYSTEM

    MDR report key: 442058 · Received February 5, 2003

    Report

    Report Number
    2432235-2003-00001
    Event Type
    Malfunction
    Date Received
    February 5, 2003
    Date of Event
    January 8, 2003
    Report Date
    February 4, 2003
    Manufacturer
    BAYER DIAGNOSTICS MFG LTD
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2003, BAYER RECEIVED NOTIFICATION VIA A COPY OF A VOLUNTARY MEDWATCH FORM, THAT A CUSTOMER WAS EXPERIENCING SERVICE PROBLEMS WITH THEIR IMMUNO 1 SYSTEM. THEY INDICATED THAT UPON TROUBLESHOOTING THE SYSTEM, THEY DETERMINED THE PROBLEM TO BE RELATED TO CLOGGED WASH LINES. THEY REPORTED THAT THIS SYSTEM ISSUE CAUSED THE HOSPITAL LABORATORY TO REPORT OUT INACCURATE RESULTS FOR CARDIAC MARKER TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAYER IMMUNO 1 SYSTEM IMMUNOASSAY SYSTEM JJE BAYER DIAGNOSTICS MFG LTD BAYER IMMUNO 1 SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization