BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD3200 SL 110

    MDR report key: 863755 · Received September 26, 2006

    Report

    Report Number
    2919069-2006-00073
    Event Type
    Other
    Date Received
    September 26, 2006
    Date of Event
    February 1, 2006
    Report Date
    August 28, 2006
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 CUSTOMER STATED A PT GENERATES LOWER HEMOGLOBIN RESULTS ON THE CELL-DYN 3200 ANALYZER WHEN SPECIMENS ARE TESTED IN THE FRAGILE WBC MODE. IN 2006, THE PT GENERATED AN HGB RESULT OF 10.1 G/GL WHEN RUN IN NORMAL PT MODE AND RESISTANT RBC MODE, BUT A RESULT OF 8.63 G/DL WAS OBTAINED WHEN THE SPECIMEN WAS RUN IN FRAGILE WBC MODE. THE CUSTOMER STATED ALTHOUGH THERE WERE NO FLAGS TO SUPPORT RUNING THE SAMPLE IN FRAGILE MODE, THE FRAGILE MODE RESULT MORE CLOSELY ALIGNED WITH THE HGB VALUE OF 9.0 G/DL OBTAINED ON THE CELL-DYN 4000. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD3200 SL 110 AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR