BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 1903892 · Received November 20, 2010

    Report

    Report Number
    1061932-2010-00222
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    September 3, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OMISSION TAKES PLACE ON DISPLAY, PRINTOUT AND IN TRANSMISSION. THE TILDE CHARACTER WORKS PROPERLY FOR PRE-ASSIGNMENT USING THE WORKLIST, OR SECONDARY MODE IF TRANSMITTED FROM THE HOST OR ENTERED MANUALLY. THAT IS, THE TILDE CHARACTER IS OMITTED ONLY WHEN SCANNED BY THE INSTRUMENT SCANNER. THE PROBABILITY THAT THE TILDE CHARACTER IS USED AS PART OF SAMPLE ID IS REMOTE. ROOT CAUSE IS UNKNOWN. INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    BECKMAN COULTER INC., DISCOVERED THAT THERE IS A POTENTIAL FOR MISIDENTIFICATION TO OCCUR, IF THE TILDE CHARACTER (~) IS USED AS PART OF THE SAMPLE ID IN THE BARCODE LABEL AND SCANNED BY THE PRIMARY MODE BARCODE READER IN HMX AND MAXM INSTRUMENTS. FOR EXAMPLE, "123~456' WOULD RESULT AS "123456' WITH THE TILDE CHARACTER OMITTED. THIS ISSUE WAS DISCOVERED INTERNALLY. NO MISIDENTIFICATION HAS OCCURRED. NO ERRONEOUS RESULTS WERE REPORTED. THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. TN HMX WITH AUTOLOADER

    Patients

    Seq Age Sex Outcome Treatment
    1