BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATALINK2000

    MDR report key: 1914261 · Received December 3, 2010

    Report

    Report Number
    2050012-2010-01424
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JQP
    PMA / PMN Number
    CL. I EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAB HAD INTENDED THE DL2000 TO NOTIFY THEM OF ANY PHY RESULT GREATER THAN 20UG/ML VIA A MESSAGE. THE DL2000 WAS CONFIGURED TO GENERATE A COMMENT (INSTEAD OF A MESSAGE). PER CUSTOMER, THE CONFIGURATION/RULE WAS CONFIGURED BY BCI. HOTLINE CORRECTED THE CONFIGURATION OF THE DL2000 TO WORK AS THE CUSTOMER DESIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND REPORTED THAT THE INSTRUMENT GENERATED A PHENYTOIN (PHY) RESULT OF ">40UG/ML". THIS RESULT WAS CORRECT. THE RESULT DID POST TO THE DL2000, AND DID POST A COMMENT, BUT DID NOT GENERATE A MESSAGE. THE OPERATOR DID NOT NOTICE THE HIGH RESULT OR COMMENT AND FAILED TO NOTIFY THE PHYSICIAN. AT THE END OF THE SHIFT (APPROXIMATELY 8 HOURS LATER), THE HIGH RESULT WAS NOTICED AND THE PHYSICIAN NOTIFIED. PER THE CUSTOMER, NO IMPACT TO THE PATIENT WAS COMMUNICATED TO THE LAB.

    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