BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 3000SL

    MDR report key: 938283 · Received April 11, 2007

    Report

    Report Number
    2919069-2007-00051
    Event Type
    Malfunction
    Date Received
    April 11, 2007
    Report Date
    March 13, 2007
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELL DYN
    Product Code
    JJE
    PMA / PMN Number
    k980614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED INSTRUMENT TO INSTRUMENT DISCREPANCY FOR HEMOGLOBIN (HGB) ON CELL-DYN 3000. THE CUSTOMER USES THE CELL-DYN 3000 AS A BACKUP INSTRUMENT TO THE CUSTOMER'S CELL-DYN 3500. THE CUSTOMER STATED THAT THE HGB OUTPUT WAS OUT OF RANGE. THE CUSTOMER WAS INSTRUCTED TO INSPECT THE LYSE SYRINGE FOR BUBBLES, CLEAN THE HGB FLOW CELL AND ADJUST THE HGB CURRENT TO BRING THE HGB OUTPUT INTO THE ACCEPTABLE RANGE. THE CUSTOMER ALSO REPORTED THAT, ON OCCASION, HGB & HCT VALUES ARE NOT MATCHING DUE TO THE HGB MIXING CHAMBER HAVING RESIDUAL BLOOD DILUTION FLUID IN IT. AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS REQUESTED. THE FSR IDENTIFIED THAT A SOLENOID ON THE CELL-DYN 3000 WOULD NOT CLOSE. THE FSR REPLACED MULTIPLE SOLENOIDS AS WELL AS ALL THE ASSOCIATED TUBING. THE INSTRUMENT WAS VERIFIED TO BE PERFORMING ACCEPTABLY. PRECISION WAS WITHIN SPECIFICATIONS AND CONTROLS WERE IN RANGE. A REVIEW OF COMPLAINT TRACKING AND TRENDING REPORTS DID NOT INDICATE ANY ADVERSE TREND FOR CELL-DYN 3000, LIST 91325-01, FOR ISSUES WITH ERRATIC HGB. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A HEMOGLOBIN RESULT OF 4.95G/DL ON THE CELL-DYN 3000 ANALYZER. THE SAMPLE RETESTED AT 9.2G/DL ON THE SAME CELL-DYN 3000 ANALYZER AND AT 9.23G/DL ON THE ACCOUNT'S CELL-DYN 3500 ANALYZER. THE RESULT OF 4.95G/DL WAS NOT REPORTED OUT OF THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 3000SL AUTOMATED HEMATOLOGY ANALYZER JJE ABBOTT DIAGNOSTICS DIVISION/CELL DYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR