BEUDAMED
    FDA Adverse Event Other Summary report: N

    DATALINK 2000

    MDR report key: 827493 · Received February 6, 2007

    Report

    Report Number
    2050012-2007-00004
    Event Type
    Other
    Date Received
    February 6, 2007
    Date of Event
    January 23, 2007
    Report Date
    February 6, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    ON 12/27/2006, A NEW HARD DRIVE WAS INSTALLED TO THE SYSTEM AND SERVICE RE-INSTALLED THE DL2000 V.6.4 SOFTWARE. IN THIS SOFTWARE THERE IS A SETTING "UPLOAD_ALPHA", WHICH CONTROLS UPLOADING OF ALPHA CHARACTERS TO THE LIS. THE DEFAULT SETTING FOR THIS FEATURE IS TURNED "ON", WHICH ALLOWS UPLOADING OF ALPHA CHARACTERS IN THE RESULT FIELD TO THE LIS. SINCE THIS PARTICULAR SYSTEM DOES NOT HANDLE ALPHA CHARACTERS IN THE RESULT FIELD, THIS FEATURE SHOULD BE TURNED "OFF." BCI HAD THE CUSTOMER CHECKED THE DL2000 SETTING WHICH WAS SET TO "ON." THE CUSTOMER WAS ASKED TO CHANGE THE SETTING TO "OFF." THE NEW SETTING WAS TESTED AND THE DL2000 IS NO LONGER UPLOADING ALPHA CHARACTERS TO THE LIS. THE INCORRECTLY CONFIGURED SETTING AT THE DL2000 IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BCI) THAT THE DATALINK2000 (DL2000) DATA MANAGER SENT AN INCORRECT RESULT TO THE LAB INFO SYSTEM (LIS). THE CUSTOMER INDICATED THAT A SUPPRESSED, OUT OF INSTRUMENT RANGE HIGH (OIR-HI) CK RESULT WAS INCORRECTLY REPORTED AS 0IU/L BY THE LIS. IT IS UNK IF THE RESULT WAS REPORTED OUT OF THE LAB. BASED ON AVAILABLE INFO, PT TREATMENT WAS NOT INITIATED OR WITHHELD AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATALINK 2000 DATA MANAGEMENT SYSTEM JGS BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA