BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTICHANNEL DISCRETE ANALYZER II (MDA)

    MDR report key: 641491 · Received October 13, 2005

    Report

    Report Number
    3002769706-2005-00034
    Event Type
    Death
    Date Received
    October 13, 2005
    Date of Event
    September 24, 2005
    Report Date
    October 12, 2005
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 9/24 SITE CALLED & QUESTIONED "CALC ERRORS" RECEIVED ON TWO MDA II SYSTEM UPDATED WITH VER. B.30 SOFTWARE ON 9/23. ON 9/27, ON 2ND CALL, CUSTOMER NOTIFIED CO OF A PT WHO PRESENTED TO ER ON WITH HEART COMPLICATIONS & WAS PUT ON HAPARIN IV AT 5P.M. FIRST SPECIMEN AT LAB AT 11:30 PM, MDA II PT RESULT REPORTED TO FLOOR, BUT SYSTEM REPORTED "CALC ERROR" ON APTT TEST. LAB REQUESTED REDDRAW OF SPECIMEN TO RERUN APTT & THIS SPECIMEN GAVE 2ND "CALC ERROR" INSTEAD OF USING AN ALTERNATE METHOD, SITE REQUESTED 3 MORE REDRAWS. AS A RESULT NO APTT RESULTS WERE AVAILABLE FOR REPORTING TO THE FLOOR. CO IS UNAWARE OF THE CUSTOMER SITE DOING AN ADDITIONAL TESTING TO RESOLVE THE MULTIPLE "CALC ERRORS". AT 8:30 PT WENT INTO CARDIAC ARREST & DIED. SITE STATES CARDIAC ARREST DUE TO INTERNAL BLEEDING. SITE FEELS PT TREATMENT DELAYED DUE TO "CALC ERRORS" & THEY FEEL THESE ERRORS ARE RELATED TO CHANGES MADE IN THE B.30 SOFTWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTICHANNEL DISCRETE ANALYZER II (MDA) MULTIPURPOSE SYSTEM IN VITRO COAG STUDIES JPA BIOMERIEUX, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death