BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 1585181 · Received January 25, 2010

    Report

    Report Number
    2919069-2010-00012
    Event Type
    Malfunction
    Date Received
    January 25, 2010
    Report Date
    January 22, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CD 18 PLUS DISK LN: 9H71-01 LOT: 9306. CD 18 CNF HGB LYS LN: 7H84-01 LOT: 73069I2. AN EVALUATION IS IN PROCESS. A FOLLOW UP MDR WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. OTHER TEXT : AN INVESTIGATION IS IN PROCESS

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT HEMOGLOBIN AND PLATELET RESULTS GENERATED BY THE CELL-DYN 1800 ANALYZER ARE HIGHER THAN EXPECTED AND ARE BEING QUESTIONED BY PHYSICIANS. THE CUSTOMER PROVIDED ONLY ONE EXAMPLE OF A PLATELET RESULT OF 30 K/UL GENERATED ON THE CELL-DYN PLATFORM. THIS SAME SAMPLE GENERATED A PLATELET RESULT OF 6 K/UL AT A REFERENCE LABORATORY (METHODOLOGY NOT PROVIDED). CONTROLS HAVE BEEN READING CLOSE TO THEIR MEANS. THE CUSTOMER NOTED THAT THE SYRINGES ON THE CELL-DYN 1800 ANALYZER WERE NOT MOVING SMOOTHLY. A SERVICE CALL WAS INITIATED. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN

    Patients

    Seq Age Sex Outcome Treatment
    1 CD DILUENT LN: 99220-02 LOT: 81802I2| CD DILUENT LN: 99220-02 LOT: 81802I2