BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD DILUENT

    MDR report key: 1862729 · Received October 8, 2010

    Report

    Report Number
    2919069-2010-00454
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Report Date
    September 23, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K081495
    Removal / Correction Number
    2919069-10/5/10-006-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE CELL-DYN EMERALD REAGENT BARCODE READ ERROR UPON INSTALLATION OF THE REAGENT IS DUE TO A MANUFACTURING ERROR. A PRODUCT RECALL LETTER WAS ISSUED INSTRUCTING CELL-DYN EMERALD CUSTOMERS WHO RECEIVED CELL-DYN EMERALD DILUENT LOT 4350 TO ENTER A NEW SERIAL NUMBER AND VERIFICATION KEY TO RUN THE ANALYZER.

    Description of Event or Problem · 1

    SIX CUSTOMER COMPLAINTS WERE IDENTIFIED INDICATING THE CELL-DYN EMERALD DILUENT COULD NOT BE USED ON THE CELL-DYN EMERALD SYSTEM DUE TO AN ERROR WITHIN THE BARCODE. WHEN SCANNED, THE DILUENT BARCODE LABEL INDICATES THAT THE VOLUME IS 10 ML RATHER THAN THE CORRECT VOLUME OF 10,000 ML. AFTER INSTALLATION, WHEN THE OPERATOR ATTEMPTS TO PRIME, THE MESSAGE, "DILUENT REAGENT IS EMPTY. PLEASE REGISTER A NEW CONTAINER OF DILUENT REAGENT" APPEARS. IF THE OPERATOR TRIES TO MANUALLY CORRECT THE VOLUME SIZE, THE INSTRUMENT GENERATES AN ERROR MESSAGE, "REGISTRATION OF NEW DILUENT REAGENT FAILED" BECAUSE THE VERIFICATION KEY IS FOR 10 ML, NOT 10,000 ML. THE SUPPLIER CONFIRMED THAT A MANUFACTURING ERROR OCCURRED DURING THE GENERATION OF THE BARCODE LABELS FOR ALL UNITS OF CELL-DYN EMERALD DILUENT, LOT 4350. THIS LOT BEGAN SHIPMENT ON SEPTEMBER 13, 2010.A PRODUCT RECALL WAS ISSUED AND REPORTED UNDER 21CFR806 FOR THE CELL-DYN EMERALD DILUENT TO THE FDA (B)(4) DISTRICT ON SEPTEMBER 29, 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 DILUENT DILUENT REAGENT FOR USE ON THE CELL-DYN EMERALD ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION 4350

    Patients

    Seq Age Sex Outcome Treatment
    1 CD EMERALD ANALYZER LN 9H39