BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL DYN EMERALD

    MDR report key: 2051205 · Received April 12, 2011

    Report

    Report Number
    2919069-2011-00161
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRINTER WAS DISCARDED AND REPLACED BY THE CUSTOMER. THE (B)(4) COLOR PRINTER IS A PERIPHERAL DEVICE, WHICH IS NOT PART OF AN ABBOTT HEMATOLOGY BILL OF MATERIAL OR THE CELL-DYN EMERALD SYSTEM ACCESSORY KIT. THIS PRODUCT IS ORDERED SEPARATELY UNDER AN ABBOTT LIST NUMBER 08H78-07 AS A CONVENIENCE TO THE CUSTOMER WHEN PLACING AN ORDER FOR A CELL-DYN EMERALD SYSTEM. THE CELL-DYN EMERALD SYSTEM OPERATOR'S MANUAL WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THEY SAW SMOKE COMING FROM THE HP6988 COLOR PRINTER, LN 8H78-07 THAT WAS ATTACHED TO THE CELL-DYN EMERALD ANALYZER. THE ACCOUNT TURNED THE PRINTER OFF. THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL DYN EMERALD AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)| (B)(4)