BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 1381748 · Received May 15, 2009

    Report

    Report Number
    2919069-2009-00157
    Event Type
    Malfunction
    Date Received
    May 15, 2009
    Date of Event
    April 21, 2009
    Report Date
    April 23, 2009
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. AN INVESTIGATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DILUENT SYRINGE DRIVE WAS DIRTY AND DRY. THE SYRINGE DRIVES WERE CLEANED AND LUBRICATED AND THE SYRINGES WERE REPLACED. THE CUSTOMER TECHNICAL ADVOCATE (CTA) DIRECTED THE CUSTOMER TO SECTION 3 OF THE CELL-DYN 1800 SYSTEM OPERATOR'S MANUAL, FOR PATIENT FLAGGING FOR DESCRIPTION OF R FLAGS AND APPROPRIATE ACTIONS. THE CTA DISCUSSED AND EXPLAINED THAT LYM RM/R0 INDICATES A SUSPECT WBC RESULT WHICH NEEDS TO BE CONFIRMED. THE CTA HAD THE CUSTOMER CHECK THE ELECTRICAL BACKGROUND AND THE WBC ELECTRICAL BACKGROUND FLUCTUATED. THE CTA HAD THE CUSTOMER CHECK THE FRONT COVER GROUND WIRE AND NO ISSUES WERE FOUND. A FIELD SERVICE REPRESENTATIVE (FSR) WAS SENT TO SERVICE THE INSTRUMENT. THE FSR FOUND THE DILUENT SYRINGE DRIVE WAS DIRTY AND DRY. THE FSR CLEANED AND LUBRICATED THE DRIVES, CHANGED THE SYRINGES AND S2 TUBING, AND VERIFIED INSTRUMENT PERFORMANCE. A REVIEW OF THE COMPLAINT HISTORY FOR THE CELL-DYN 1800 (B)(4) FROM THE COMPLAINT DATE ((B)(6) 2009) UNTIL PRESENT FOUND NO OTHER COMPLAINT RELATED TO THE REPORTED ISSUE. THE CELL-DYN 1800 SYSTEM OPERATOR'S MANUAL, LIST NUMBER 07H80-01, (B)(4) PRINCIPLES OF OPERATION, PROVIDES EXPLANATION AND SUGGESTION FOR THE LYM RM/R0 SUSPECT PARAMETER FLAG. TROUBLESHOOTING AND DIAGNOSTICS, PROVIDES TROUBLESHOOTING STEPS FOR IMPRECISE OR INACCURATE DATA. IF ASSISTANCE IS NEEDED FOR ANY TECHNICAL OR OPERATIONAL PROBLEMS, THE CUSTOMER IS INSTRUCTED TO CONTACT THE LOCAL COUNTRY SERVICE AND SUPPORT CENTER. A REVIEW OF COMPLAINTS DID NOT IDENTIFY ANY TRENDS. BASED ON THE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED FOR THE CELL-DYN 1800, LIST NUMBER 07H77-01, FOR THE REPORTED ISSUE. THERE IS NO SYSTEMATIC ISSUE WITH THE CELL-DYN 1800 PRODUCT LINE. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED DISCREPANT HIGH WBC RESULTS HAVE BEEN INTERMITTENTLY GENERATED ON THE CELL-DYN 1800. A PATIENT GENERATED A WBC VALUE OF 23.2 K/UL WITH A LYM RM FLAG. THE RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. ANOTHER SAMPLE WAS OBTAINED THE FOLLOWING DAY, YIELDING A WBC VALUE OF 9.7 K/UL WITH NO FLAGS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN

    Patients

    Seq Age Sex Outcome Treatment
    1