BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 22 CALIBRATOR

    MDR report key: 789655 · Received December 1, 2006

    Report

    Report Number
    2919069-2006-00110
    Event Type
    Malfunction
    Date Received
    December 1, 2006
    Report Date
    September 28, 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
    TX, 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 PLATELET QC WAS OUT OF RANGE HIGH ON THEIR CD3200 SL ANALYZER. THEY WERE NOT USING THIS ANALYZER FOR PATIENT TESTING AS THEY WERE STILL PERFORMING CORRELATIONS. THEY STATED THAT THEY HAD CALIBRATED THE ANALYZER WITH CELL-DYN 22 CALIBRATOR LOT 3100.

    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