BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL DYN EMERALD

    MDR report key: 1872956 · Received October 18, 2010

    Report

    Report Number
    2919069-2010-00478
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K081495
    Removal / Correction Number
    2919069-10/15/10-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CELL-DYN EMERALD CPU BOARDS, PART NUMBERS: 8701686901 AND 8701686902. THE CAUSE OF THE CELL-DYN EMERALD INITIALIZATION (POWERING UP) ISSUE WAS DUE TO A PROBLEM WITH HOW THE FLASH MEMORY IS INITIALIZED ON THE CELL-DYN EMERALD CPU BOARD. ABBOTT ISSUED A PRODUCT CORRECTION LETTER TO ALL CELL-DYN EMERALD CUSTOMERS WHO RECEIVED THE AFFECTED ANALYZERS, INSTRUCTING CUSTOMERS TO INSTALL A PRINTER DRIVER WHICH WILL ELIMINATE THE POSSIBILITY FOR THE ERROR TO OCCUR.

    Description of Event or Problem · 1

    THE CELL-DYN EMERALD IS AN AUTOMATED HEMATOLOGY ANALYZER INTENDED FOR IN VITRO DIAGNOSTIC USE IN THE CLINICAL LABORATORY. AFTER INSTALLATION OF THE ANALYZER, SOME CELL-DYN INSTRUMENTS WOULD NOT INITIALIZE AND POWER UP. THE ERROR MESSAGE GENERATED IS "NO MEMORY AVAILABLE." UPON FURTHER EVALUATION BY THE SUPPLIER, IT WAS DETERMINED THE CELL-DYN EMERALD CENTRAL PROCESSING UNIT (CPU) BOARD APPEARED TO NOT HAVE ENOUGH MEMORY TO INITIALIZE AND POWER UP THE INSTRUMENT DUE TO A PROBLEM WITH HOW THE FLASH MEMORY IS INITIALIZED. IN THIS FAILURE MODE, THE INSTRUMENT IS UNABLE TO GENERATE RESULTS AND HAS THE POTENTIAL TO CAUSE A DELAY IN GENERATING PATIENT RESULTS GREATER THAN ONE HOUR AND UP TO 24 HOURS. FOR CERTAIN ASSAYS, THIS COULD IMPACT PATIENT MANAGEMENT. A PRODUCT CORRECTION HAS BEEN ISSUED AND REPORTED UNDER 21CFR806 FOR THE CELL-DYN EMERALD TO THE FDA (B)(4) ON (B)(4) 2010. ABBOTT HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS RELATED TO THIS ISSUE.

    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 CELL-DYN EMERALD ANALYZER CPU BOARD