BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD DILUENT

    MDR report key: 1874332 · Received October 19, 2010

    Report

    Report Number
    2919069-2010-00488
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Report Date
    September 24, 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
    NC, US
    Reporter Occupation
    SERVICE PERSONNEL

    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. AN INVESTIGATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE ABBOTT FIELD SERVICE REPRESENTATIVE STATED THE LABEL ON A CELL-DYN EMERALD DILUENT BOTTLE SCANNED AS 10 ML INSTEAD OF 10,000 ML. THE CUSTOMER MANUALLY ENTERED A NEW SERIAL NUMBER AND VERIFICATION KEY 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 SN (B)(4)