BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD

    MDR report key: 2043979 · Received April 7, 2011

    Report

    Report Number
    2919069-2011-00116
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Report Date
    February 18, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CELL-DYN EMERALD CLEANER MANUFACTURED 8/10/10, EXPIRES 6/18/12. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. AN INVESTIGATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEFICIENCY WAS IDENTIFIED. THE INVESTIGATION DEMONSTRATED CONCLUSIVELY THAT ONLY CELL-DYN EMERALD CLEANER LOT 4349 WAS AFFECTED. THE ROOT CAUSE IS THE VENDOR (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED RBC QUALITY CONTROLS WERE OUT OF RANGE LOW ON A CELL-DYN EMERALD ANALYZER USING CELL-DYN EMERALD CLEANER LOT 4349. THE CUSTOMER BLEACHED THE INSTRUMENT EVERY 2-3 DAYS TO RESOLVE THE ISSUE. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    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 CLEANER LN 9H46 LOT 4349| CELL-DYN EMERALD CLEANER LN 9H46-02 LOT 4349