BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN DILUENT/SHEATH

    MDR report key: 806081 · Received January 5, 2007

    Report

    Report Number
    2919069-2006-00124
    Event Type
    Malfunction
    Date Received
    January 5, 2007
    Date of Event
    December 22, 2006
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKL
    PMA / PMN Number
    k961439
    Removal / Correction Number
    2919069-1/4/07-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT. AN INVESTIGATION IS IN PROGRESS. CELL-DYN 4000 ANALYZER 510(K) NUMBER K961439/S1; CELL-DYN SAPPHIRE ANALYZER 510(K) NUMBER K051215; CELL-DYN RUBY ANALYZER 510(K) NUMBER K061667.

    Description of Event or Problem · 1

    USE OF THE DILUENT SHEATH LOT 42063I2 CAN CAUSE ERRORS IN RESULTS WHEN USED ON THE CELL-DYN RUBY, CELL-DYN SAPPHIRE AND CELL-DYN 4000. RESULTS THAT MAY BE IMPACTED INCLUDE RBC, MCV, RDW, PLATELETS AND MPV. THE IMPACT TO RESULTS VARIES BY INSTRUMENT TYPE AS WELL AS THE MATERIAL TESTED, I.E., CONTROL, CONTROL TYPE OR WHOLE BLOOD. RESULTS THAT MAY BE IMPACTED INCLUDE SMALL (LESS THAN 5%) SHIFTS IN RBC, MCV, RDW, AND MPV ALONG WITH 10 - 20% SHIFT IN OPTICAL PLATELET COUNTS. A RECALL WAS ISSUED AND REPORTED UNDER 21 CFR 806 TO THE FDA ON JANUARY 4, 2007. ABBOTT HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS RELATED TO THIS LOT OF DILUENT SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN DILUENT/SHEATH DILUENT/SHEATH FOR USE ON THE CELL-DYN SAPPHIRE, CELL-DYN 40 GKL ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA 42063I2

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO CELL-DYN SAPPHIRE LIST 8H00-01| CELL-DYN 4000 LIST 1H01-01| CELL-DYN RUBY LIST 8H67-01