BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 22 CALIBRATOR

    MDR report key: 789661 · Received December 1, 2006

    Report

    Report Number
    2919069-2006-00105
    Event Type
    Malfunction
    Date Received
    December 1, 2006
    Report Date
    September 26, 2006
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/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
    GA, 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 CUSTOMER INFORMED THE CUSTOMER TECHNICAL ADVOCATE (CTA) THAT THEY WERE HAVING PROBLEMS WITH CONTROLS OUT OF RANGE FOR PLATELET ON THE CELL-DYN 3200 SL ANALYZER. THE CUSTOMER HAD CALIBRATED THE ANALYZER WITH THE CELL-DYN 22 CALIBRATOR LOT #3100. THE CTA DISCUSSED RECALL LETTER WITH THE ACCOUNT. THERE WAS NO REPORT OF SUSPECT PATIENT RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA CELL-DYN 3200 SL ANALYZER LIST # 4H60-01,