BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL DYN SAPPHIRE ANALYZER

    MDR report key: 658523 · Received January 3, 2006

    Report

    Report Number
    2919069-2005-00085
    Event Type
    Other
    Date Received
    January 3, 2006
    Date of Event
    December 13, 2005
    Report Date
    December 29, 2005
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE CELL-DYN SAPPHIRE MISREAD A PATIENT SAMPLE BARCODE AS 7$5 WHICH RESULTED IN AN INCORRECT SAMPLE IDENTIFICATION (SID). THE ACTUAL BARCODE WAS 6992938. THE ERROR WAS NOT CAUGHT UNTIL THE OPERATOR REVIEWED THE INFORMATION IN THE LABORATORY INFORMATION SYSTEM (LIS). THE HOST LIS QUERIED ON 7$5 AND RESPONDED TO THE QUERY BY POSTING THE TRANSMISSION TO AN INCORRECT PATIENT WITH BARCODE 6992997. THE CUSTOMER READ THE BARCODE WITH A HANDHELD SCANNER AND THE BARCODE WAS READ CORRECTLY. A SERVICE REPRESENTATIVE READ THE BARCODE IN DIAGNOSTICS CONTROLS ON THE CD SAPPHIRE AND THE LABEL AGAIN READ CORRECTLY. THE BARCODE ALSO READ CORRECTLY USING ANOTHER INSTRUMENT (PLATFORM NOT PROVIDED). NO PATIENT DATA WAS REPORTED FROM THIS SAMPLE MISREAD. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL DYN SAPPHIRE ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN