BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD3200SL

    MDR report key: 906796 · Received September 4, 2007

    Report

    Report Number
    2919069-2007-00132
    Event Type
    Malfunction
    Date Received
    September 4, 2007
    Date of Event
    May 30, 2005
    Report Date
    August 6, 2007
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELL DYN
    Product Code
    GKZ
    PMA / PMN Number
    K972354
    Removal / Correction Number
    2919069-11/8/06-005-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROGRESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE HEMOGLOBIN CONTROL VALUES, RUN ON THE CELL-DYN 3200 ANALYZER, ARE EITHER SHIFTING DOWNWARD OR ARE OUT OF RANGE. THE CUSTOMER STATED THAT THE PATIENT SAMPLES ARE ACCEPTABLE BECAUSE THEY WERE VERIFIED. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD3200SL AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELL DYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR CD22 TRIVIAL CONTROLS LIST # 99106 LOT # 0119