BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 22 CALIBRATOR

    MDR report key: 793883 · Received December 4, 2006

    Report

    Report Number
    2919069-2006-00118
    Event Type
    Malfunction
    Date Received
    December 4, 2006
    Date of Event
    September 18, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION TO DETERMINE THE CAUSE OF THE STABILITY ISSUE IS ONGOING. THIS IS A FINAL REPORT.

    Description of Event or Problem · 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. A RECALL WAS ISSUED AND REPORTED UNDER 21 CFR 806 TO THE FDA DISTRICT OFFICE ON 09/26/2006. ABBOTT HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS RELATED TO THE AFFECTED LOTS OF CELL-DYN 22 CALIBRATORS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA CELL-DYN 3200 ANALYZER LIST 4H60