BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL-DYN 3200 CS 110V

    MDR report key: 773825 · Received August 15, 2006

    Report

    Report Number
    2919069-2006-00056
    Event Type
    Other
    Date Received
    August 15, 2006
    Date of Event
    July 17, 2006
    Report Date
    July 17, 2006
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS. NO EVALUATION, RESULTS OR CONCLUSIONS CAN BE MADE AT THIS TIME. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROGRESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED DISCREPANT RESULTS ON 4 PATIENTS USING THE CD3200 ANALYZER. PATIENT SPECIMENS WERE REPEATED AT ANOTHER LABORATORY WITH DIFFERING RESULTS. THE ACCOUNT STATED THEY WERE BUSY AND DID NOT FOLLOW THE SUGGESTED ACTION FLAGS AND LABORATORY PROTOCOLS FOR CONFIRMING RESULTS PRIOR TO RELEASING RESULTS FROM THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THIS REPORT IS FOR PATIENT 3 OUT OF A TOTAL OF 4 PATIENTS. PATIENT: CD3200 AT 5:45AM; WBC=4.04 K/UL, RBC=3.38 M/UL, HBG=9.59 G/DL, HCT=29.2%, PLT=180 K/UL. PATIENT; CD3200 AT 10:15AM, WBC=6.43 K/UL, RBC=6.92 M/UL, HBG=21.5 G/DL, HCT=66.8%, PLT=73.5 K/UL. PATIENT: ANOTHER METHOD AND REDRAW AT 1:08PM; WBC=13.8 K/UL, RBC=3.00 M/UL, HBG=8.9 G/DL, HCT=28.5%, PLT=353 K/UL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 3200 CS 110V AUTOMATED HEMATOLOGY ANALYZER JJE ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR