BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL DYN EMERALD

    MDR report key: 2061113 · Received April 18, 2011

    Report

    Report Number
    2919069-2011-00165
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Report Date
    April 14, 2011
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 CUSTOMER OBSERVED THE ERROR MESSAGE "NO INTERNAL MEMORY FAULT" GENERATED FROM THE CELL-DYN EMERALD HEMATOLOGY ANALYZER. THE CUSTOMER WASN'T SURE IF A POWER OUTAGE OCCURRED, HOWEVER, THE PRINTER LIGHTS WERE ON. FIELD SERVICE WAS DISPATCHED TO THE CUSTOMER, WHERE THE CPU BOARD REPLACEMENT RESOLVED THE ISSUE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    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 CPU BOARD