BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAYER IMMUNO I

    MDR report key: 266574 · Received March 2, 2000

    Report

    Report Number
    MW1018298
    Event Type
    Malfunction
    Date Received
    March 2, 2000
    Date of Event
    February 29, 2000
    Report Date
    February 29, 2000
    Manufacturer
    BAYER CORP. DIAGNOSTICS DIVISION
    Product Code
    JJC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE LABORATORY HAS 2 BAYER IMMUNO I ANALYZERS WHICH PERFORM IMMUNOASSAYS, FERTILITY TESTS AND CARDIAC MARKERS. DUE TO THE LEAP YEAR DATE AND THE LIS INTERFACE FORMAT UTILIZED, THE COMPUTER SYSTEMS ON THESE ANALYZERS LOCKED UP RENDERING THEM INOPERABLE. TESTING WAS DELAYED APPROXIMATELY 3 HOURS WHILE BAYER ASSISTED FACILITY IN BY-PASSING THE PROBLEM IN ORDER TO PERFORM TESTING ON THESE ANALYZERS. THE LIS DOWNLOAD FUNCTION WAS INACTIVATED, THE INSTRUMENTS WERE REBOOTED AND BECAME OPERABLE. BAYER IS STILL WORKING ON FIXING THIS PROBLEM BUT TESTING CAN BE PERFORMED WITHOUT THE LIS DOWNLOAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAYER IMMUNO I IMMUNOASSAY ANALYZER JJC BAYER CORP. DIAGNOSTICS DIVISION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other