BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL DYN SAPPHIRE ANALYZER

    MDR report key: 1060040 · Received June 12, 2008

    Report

    Report Number
    2919069-2008-00604
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THE CELL-DYN SAPPHIRE ANALYZER HAS GENERATED DISCREPANT WBC RESULTS. IN 2008, A CHILD WAS SENT TO THE EMERGENCY ROOM WITH A FEVER, ABDOMINAL PAIN AND TONSILLITIS. BLOOD WORK WAS ORDERED, THE INITIAL WBC RESULT = 34,100. THE DOCTOR PROCEEDED WITH THE TREATMENT AND HOSPITALIZATION (TYPE OF TREATMENT NOT PROVIDED). THE NEXT DAY, THE PATIENT WAS REDRAWN AND THE WBC = 13,500, THE CELL-DYN RUBY WBC RESULT = 12,000. THE INITIAL SAMPLE WAS RETESTED ON THE CD SAPPHIRE AND THE WBC = 18,100 AND THE CD RUBY WBC RESULT = 20,200. UNITS OF MEASUREMENT WERE NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization