BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1600 120V

    MDR report key: 485339 · Received September 18, 2003

    Report

    Report Number
    2919069-2003-00025
    Event Type
    Malfunction
    Date Received
    September 18, 2003
    Date of Event
    August 25, 2003
    Report Date
    September 18, 2003
    Manufacturer
    ABBOTT DIAGNOSTIC DIVISION/CELL DYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE CELL-DYN 1600 ANALYZER GENERATED ERRATIC RESULTS ON THE NIGHT SHIFT ON AN EMERGENCY ROOM PATIENT. THE PATIENT WAS SCHEDULED FOR A TRANSFUSION DUE TO A HEMOGLOBIN RESULT OF 7.1 G/DL WITH A HEMATOCRIT OF 13.0%. A PRE-TRANSFUSION SAMPLE WAS DRAWN WITH A HEMOGLOBIN RESULT OF 13.0 G/DL AND A HEMATOCRIT OF 38.0%. THE SAMPLE FROM THE NIGHT SHIFT WAS REPEATED AND CORRELATED WITH THE RESULTS FROM THE PRE-TRANSFUSION SAMPLE. CONTROLS HAVE REMAINED WITHIN SPECIFICATIONS ON ALL RUNS AND NO FLAGS OR ALERTS WERE GENERATED. THE TRANSFUSION WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1600 120V AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTIC DIVISION/CELL DYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA