BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 935758 · Received April 12, 2007

    Report

    Report Number
    2919069-2007-00053
    Event Type
    Malfunction
    Date Received
    April 12, 2007
    Date of Event
    February 27, 2007
    Report Date
    March 13, 2007
    Manufacturer
    ABBOTT DIAGNOSTICS DIV/CELLDYN
    Product Code
    GKL
    PMA / PMN Number
    K051215
    Removal / Correction Number
    2919069-11/30/06-009-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA/510(K): K961439. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES GETTING HIGH PLATELET IMPEDANCE BACKGROUND COUNTS (9.5, 33.8, 17.2) WHEN USING THE CELL-DYN SAPPHIRE ANALYZER WITH CELL-DYN SAPPHIRE/REAGENT/4K DILUENT/SHEATH, 20L. NO PATIENT SAMPLES HAVE BEEN RUN SINCE THE BACKGROUND ISSUE STARTED. THERE IS NO IMPACT TO PATIENT MANAGEMENT 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 GKL ABBOTT DIAGNOSTICS DIV/CELLDYN NA 4810712

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO CELL-DYN SAPPHIRE ANALYZER| LIST# 8H00-01