BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATALINK

    MDR report key: 385741 · Received March 26, 2002

    Report

    Report Number
    2050012-2002-00004
    Event Type
    Malfunction
    Date Received
    March 26, 2002
    Date of Event
    February 26, 2002
    Report Date
    March 22, 2002
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JOP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINT STATES THAT THE DATALINK DATA MANAGER COMBINED ARCHIVED TESTS RESULTS FROM DIFFERENT PATIENTS WHEN AN ARCHIVED RESULT WAS PRINTED. FIELD SERVICE PERSONNEL COULD NOT DUPLICATE THE EVENT DESCRIBED. NO TREATMENT HAS BEEN AFFECTED BY THIS EVENT, HOWEVER WHEN RESULTS FROM ONE PATIENT ARE ADDED TO A DIFFERENT PATIENT'S REPORT, THE POTENTIAL EXISTS FOR INAPPROPRIATE TREATMENT TO BE INITIATED. SINCE THE BECKMAN COULTER DATALINK SYSTEM CAN NOT BE POSITIVELY RULED OUT AS A CONTRIBUTOR TO THIS EVENT, BECKMAN COULTER BELIEVES THIS EVENT MEETS THE REPORTING CRITERIA OF 21 CFR 803.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other