BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD 3700 SL

    MDR report key: 791668 · Received November 21, 2006

    Report

    Report Number
    2919069-2006-00089
    Event Type
    Other
    Date Received
    November 21, 2006
    Date of Event
    October 17, 2006
    Report Date
    October 31, 2006
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    JJE
    PMA / PMN Number
    k980614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    UNKNOWN

    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

    ON OCTOBER 17, 2006 THE CELL-DYN 3700 SL ANALYZER GENERATED A HEMOGLOBIN (HGB) RESULT OF 8.9 G/DL FROM THE CLOSED MODE. THE RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. A NEW SAMPLE WAS SENT TO THE LAB ON OCTOBER 20, 2006 AND THE HGB RESULT WAS 14.5 G/DL. THIS SAMPLE WAS TESTED AT ANOTHER FACILITY AND THE HGB WAS 14.2 G/DL. THE ORIGINAL SAMPLE FROM OCTOBER 17, 2006 WAS RETESTED IN THE OPEN MODE ON THE CELL-DYN 3700 SL AND THE HGB WAS 13.6 G/DL. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD 3700 SL AUTOMATED HEMATOLOGY ANALYZER JJE ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR