BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD DILUENT

    MDR report key: 1862727 · Received October 8, 2010

    Report

    Report Number
    2919069-2010-00473
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Report Date
    September 21, 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
    NE, 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. OTHER TEXT : AN INVESTIGATION IS IN PROCESS

    Description of Event or Problem · 1

    THE ABBOTT SPECIALIST STATED THE LABEL ON A CELL-DYN EMERALD DILUENT BOTTLE SCANNED AS 10 ML INSTEAD OF 10,000 ML. THE CUSTOMER WAS INSTRUCTED ON ENTERING THE LOT AND VERIFICATION KEY MANUALLY. A NEW LOT OF CELL-DYN EMERALD DILUENT WAS SHIPPED TO THE CUSTOMER 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 DILUENT DILUENT REAGENT FOR USE ON THE CELL-DYN EMERALD ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION 4350

    Patients

    Seq Age Sex Outcome Treatment
    1 CELL-DYN EMERALD LN 9H39-01 (B)(4)