BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CDS/R/4K DILUENT/SHEATH, 20L

    MDR report key: 806895 · Received January 4, 2007

    Report

    Report Number
    2919069-2007-00008
    Event Type
    Malfunction
    Date Received
    January 4, 2007
    Date of Event
    October 18, 2006
    Report Date
    December 15, 2006
    Manufacturer
    ABBOTT DIAGNOSTICS DIV/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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USE OF 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 INCLUDED SMALL (LESS THAN 5%) SHIFTS IN RBC, MCV, RDW, AND MPV ALONG WITH 10-20% SHIFT IN OPTICAL PLATELET COUNTS. 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 STATES THAT CONTROLS WERE OUT OF RANGE HIGH AND LOW FOR MULTIPLE LEVELS. THE CUSTOMER STATES THAT THE ISSUE STARTED WHEN A NEW DILUENT/SHEATH REAGENT LOT #42063I2 WAS INSTALLED ON THE CELL-DYN 4000 ANALYZER. THERE WERE NO PT RESULTS AFFECTED OR REPORTED OUT OF THE LAB. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CDS/R/4K DILUENT/SHEATH, 20L DILUENT/SHEATH FOR USE ON THE CELL-DYN SAPPHIRE, CELL-DYN 40 GKL ABBOTT DIAGNOSTICS DIV/CELLDYN NA 42063I2

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO CELL-DYN 4000 ANALYZER LIST NO.1H01-01