BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATALINK 2000

    MDR report key: 1032215 · Received April 21, 2008

    Report

    Report Number
    2050012-2008-00017
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    April 4, 2008
    Report Date
    April 21, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: TWO (2) FLAGS, "DL" (DYNAMIC LOW), AND SH (BLANK RATE HIGH) WERE UPLOADED WITH THE SUPPRESSED CRP RESULT. UPON SETUP REVIEW, IT WAS NOTED THAT A RULE HAD BEEN CONFIGURED ON THE DL2000 THAT STATED IF THE RESULT "CONTAINS DL", MODIFY THE RESULT TO "<0.5"MG/DL. THE SOURCE OF THE RULE IS UNK. CUSTOMER HAS BEEN EDUCATED BY BCI IN THE USE OF "CONTAINS" IN RULES AND THE RULE HAS BEEN CORRECTED. AN INCORRECTLY CONFIGURED RULE AT THE DL2000 HAS BEEN CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BCI) THAT DATALINK2000 DATA MANAGER (DL2000) INCORRECTLY REPORTED A SUPPRESSED C-REACTIVE PROTEIN (CRP) RESULT TO THE LAB INFORMATION SYSTEM (LIS). A PT SAMPLE WAS TESTED FOR CRP AND A RESULT OF "<0.5MG/DL" WAS UPLOADED TO THE LIS. THE INSTRUMENT PRINTOUT SHOWED THE CRP RESULT AS "RESULT SUPPRESSED, BLANK RATE HIGH". UPON REVIEW OF A RULE AT THE DL2000, THE ACTUAL CRP RESULT WAS AMENDED TO 2.4MG/DL. 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 JQP BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA