BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATALINK2000

    MDR report key: 1973472 · Received January 30, 2011

    Report

    Report Number
    2050012-2011-00268
    Event Type
    Malfunction
    Date Received
    January 30, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JQP
    PMA / PMN Number
    CL. I EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMMENTS ARE NORMALLY ADDED UPON MANUAL DIFFERENTIAL, BUT IN THIS CASE THERE WAS NO APPARENT OPERATOR ACTION TO ADD THE COMMENT. THE DATA WAS FORWARDED TO THE SOFTWARE VENDOR, (B)(4). PER (B)(4), THE MANUAL DIFFERENTIAL WAS PERFORMED WITH THE COMMENT, BUT THE ISSUE IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND REPORTED THAT THE LABORATORY NOTICED RED BLOOD COUNT (RBC) MORPHOLOGY COMMENTS INCORRECTLY POSTED TO FIVE (5) SAMPLE REQUESTS. THESE COMMENTS WERE NOT UPLOADED FROM THE INSTRUMENT. THE RESULTS WERE REPORTED OUT OF THE LAB. THE REPORTS WERE AMENDED (THE COMMENT WAS REMOVED). TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE ERRONEOUS COMMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATALINK2000 DATA MANAGEMENT SYSTEM JQP BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1