BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 22 CALIBRATOR

    MDR report key: 789630 · Received December 1, 2006

    Report

    Report Number
    2919069-2006-00109
    Event Type
    Malfunction
    Date Received
    December 1, 2006
    Report Date
    October 5, 2006
    Manufacturer
    ABBOTT DIAGNOSTICS DIV/CELLDYN
    Product Code
    KRZ
    PMA / PMN Number
    K902892/A
    Removal / Correction Number
    2919069-9/26/06-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON-MARKET INSTABILITY FOR PLATELETS WITH CELL-DYN 22 CALIBRATOR LOTS 3098 AND 3099 IS BEING EXPERIENCED. THE CALIBRATOR COULD READ HIGHER BY AT LEAST 10% ON THE CELL-DYN RUBY AND AS MUCH AS 22% ON THE CELL-DYN 3200. IF THIS CALIBRATOR IS USED AND THE CALIBRATION FACTOR ON THE INSTRUMENT IS ADJUSTED, A NEGATIVE PLATELET SAMPLE BIAS COULD RESULT. AS A PRECAUTION, LOT 3100 WAS ALSO REMOVED FROM USE. INVESTIGATION INTO THE CAUSE OF THIS INSTABILITY IS IN PROGRESS. 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 THAT QC WAS OUT OF RANGE FOR ALL LEVELS WITH CD3000 CONTROL LOT 0127 ON THEIR CD3200 CS ANALYZER. THE ACCOUNT HAD CALIBRATED THE ANALYZER WITH CELL-DYN 22 CALIBRATOR LOT 3100. THE CUSTOMER TECHNICAL ADVOCATE SENT THE ACCOUNT CD22 CALIBRATOR LOT 3101. THE ACCOUNT CALIBRATED WITH THE NEW LOT AND THEIR QC WAS MUCH CLOSER TO THE MEAN. THERE WAS NO REPORT OF SUSPECT PT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 22 CALIBRATOR CD22 CALIBRATOR KRZ ABBOTT DIAGNOSTICS DIV/CELLDYN NA 3100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA CELL-DYN 3200 CS ANALYZER LIST # 4H59-01