BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATALINK2000

    MDR report key: 2973180 · Received February 21, 2013

    Report

    Report Number
    2050012-2013-00103
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 27, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JQP
    PMA / PMN Number
    CLASS I EXEM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTINUED USING WINDOWS NT VERSION OF DL2000 EVEN AFTER BEING NOTIFIED OF THE DISCONTINUANCE. A SIMILAR EVENT WAS REPORTED BY THE CUSTOMER ON (B)(6) 2012. PLEASE SEE MEDWATCH #2050012-2013-00104 FOR THE REPORT OF THE EVENT ON (B)(6) 2012.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DATALINK2000 (DL2000), WHICH IS A DATA MANAGEMENT SYSTEM, HAD ASSIGNED THE SAME PATIENT DEMOGRAPHICS TO 2 DIFFERENT PATIENT SAMPLES. THE CUSTOMER INDICATED THAT INCORRECT PATIENT DEMOGRAPHICS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER NOTED THAT THE RESULTS FOR THE TWO SAMPLE IDENTIFICATION NUMBERS (IDS) WERE CORRECT BUT THE DL2000 HAD ASSIGNED THE SAME PATIENT DEMOGRAPHICS TO BOTH SAMPLE IDS. THE CUSTOMER'S LABORATORY INFORMATION SYSTEM (LIS) HAD THE CORRECT PATIENT DEMOGRAPHICS FOR EACH SAMPLE ID AND ONCE DATA FROM THE DL2000 WAS UPLOADED TO THE LIS, THE RESULTS WOULD BE CORRECTLY ASSIGNED TO THE CORRECT DEMOGRAPHICS BY THE LIS. NO ERRONEOUS RESULTS WERE GENERATED OR REPORTED OUT OF THE LABORATORY AND THERE WAS NO AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER TECHNICAL SUPPORT (CTS) ATTEMPTED TO RETRIEVE DATA FILES FROM THE EVENT BUT HAD BEEN OVERWRITTEN AND WAS NOT AVAILABLE. THE CTS NOTED THAT THE DL2000 WAS COORDINATING DATA FROM 5 DIFFERENT INSTRUMENTS AND THAT THE HARD DRIVE WAS FULL. ATTEMPTS TO FREE DRIVE SPACE WERE UNSUCCESSFUL AND THE CONSOLE WAS NOT PROPERLY STORING NEW DATA DUE TO THE LACK OF DRIVE SPACE. DEMOGRAPHICS FROM OLD SAMPLES WOULD NOT DELETE AND THE CTS REPLACED THE DATABASE ON (B)(4) 2013. THE CUSTOMER USES A RADISYS WINDOWS NT SYSTEM TO RUN THE DL2000 WHICH WAS DISCONTINUED BY BECKMAN COULTER EFFECTIVE DECEMBER 31, 2009. ALTHOUGH THE DL2000 APPEARS TO HAVE HAD A DATABASE CORRUPTION, THE CUSTOMER HAD BEEN NOTIFIED ON THAT THE WINDOWS NT VERSION OF DL2000 WAS DISCONTINUED AND IS NO LONGER SUPPORTED. DESPITE THE DISCONTINUANCE NOTIFICATION SENT ON AUGUST 07, 2009, THE CUSTOMER CONTINUED TO USE THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76122 DATALINK2000 CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1