BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD3200 SL 110

    MDR report key: 1061555 · Received June 17, 2008

    Report

    Report Number
    2919069-2008-00606
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K972354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 STATED AFTER CLEANING THE SHEAR VALVE AND REPLACING THE PERISTALTIC PUMP TUBING ON THEIR CELL-DYN 3200 ANALYZER DUE TO WOC FLOW ERRORS, ERRATIC WBC RESULTS WERE GENERATED. THE CUSTOMER CLEANED THE OPTICAL FLOW CELL AND VERIFIED BACKGROUND AND QC WERE WITHIN RANGE. AFTER RUNNING ONE RACK IN CLOSED MODE, THE CUSTOMER NOTICED ONE PT SAMPLE HAD A WBC VALUE OF 5.71 K/UL WITH A BAND FLAG. THE SAMPLE WAS REPEATED IN CLOSED MODE YIELDING A WBC RESULT OF 33.9 K/UL WHILE ALL THE OTHER PARAMETERS MATCHED THE ORIGINAL TEST RESULTS. THE SAMPLE WAS REPEATED IN OPEN MODE WITH WBC OF 6.0 K/UL. NO RESULTS WERE REPORTED AND THERE WAS NO IMPACT TO PT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD3200 SL 110 AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI