BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATALINK/DL2000 DATA MANAGER, COMMAND CENTRAL

    MDR report key: 2172090 · Received June 15, 2011

    Report

    Report Number
    2050012-2011-02178
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI HOTLINE CUSTOMER SERVICE REP CONFIRMED THAT THE CUSTOMER HAD INCORRECTLY CONFIGURED THE RULE ON THE DL2000 TO CHANGE ANY CRP RESULT THAT CONTAINS "DL" TO "<0.5." THE HOTLINE ASSISTED THE CUSTOMER TO CORRECT THE CONFIGURATION OF THE RULE AND ADVISED THAT ALL OTHER CONFIGURATIONS SHOULD BE CHECKED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 TO OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INCORPORATED (BCI), AND REPORTED THAT THEY OBTAINED AN ERRONEOUSLY LOW READING OF "< 0.5 MG/DL" FOR CRP (C-REACTIVE PROTEIN) FOR ONE PT FROM THE DATALINK/DL2000 DATA MANAGER SYSTEM WHICH WAS CONNECTED TO THE DXC INSTRUMENT. THE DXC INSTRUMENT HAD UPLOADED A BH DL (BLANK HIGH, DYNAMIC LOW) SUPPRESSED ERROR CODE FOR CRP TO THE DL2000 CONSOLE AND UPON RECOGNIZING THIS FLAG, THE LIS CONNECTED TO THE DL2000 REPORTED THE CRP RESULT AS "< 0.5 MG/DL." IT WAS LATER DISCOVERED THAT THE SAMPLE WAS LIPEMIC BUT THAT THE TECHNICIAN HAD DILUTED THE SAMPLE AND IT HAD GIVEN RISE TO THE RESULT OBTAINED. THE RESULT WAS REPORTED TO THE PHYSICIAN BUT IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO PT MANAGEMENT. THE CUSTOMER DID NOT INDICATE IF THE SAMPLE WAS RE-RUN AND DID NOT PROVIDE ANY SAMPLE DATA OR PT DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATALINK/DL2000 DATA MANAGER, COMMAND CENTRAL JQP BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK