BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CDSAPPHIRE, CD4000, CD3200 DILUENT SHEATH

    MDR report key: 973688 · Received December 21, 2007

    Report

    Report Number
    2919069-2007-00250
    Event Type
    Malfunction
    Date Received
    December 21, 2007
    Date of Event
    June 18, 2007
    Report Date
    June 25, 2007
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELL DYN
    Product Code
    GKZ
    PMA / PMN Number
    K961439
    Removal / Correction Number
    Z-07080-2007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS IDENTIFIED THAT MULTIPLE LOTS OF DILUENT/SHEATH REAGENT USED ON MULTIPLE CELL-DYN INSTRUMENTS WERE YIELDING ELEVATED PLATELET BACKGROUND COUNTS. THE PROBABLE CAUSE OF THE OUT OF RANGE HIGH PLATELET BACKGROUNDS IN DILUENT/SHEATH REAGENT WAS DETERMINED TO BE THE PRESENCE OF TRACE IMPURITIES IN THE WATER. THE SOURCE AND IDENTITY OF THE IMPURITIES WERE NOT IDENTIFIED. ATTEMPTS TO DETERMINE THE IDENTIFY OF THE IMPURITIES CAUSING ELEVATED PLATELET BACKGROUND COUNTS IN DILUENT/SHEATH WERE INCONCLUSIVE DUE TO COMPLEXITY OF THE REAGENT AND THE NUMBER AND NATURE OF THE TRACE IMPURITIES PRESENT IN THE WATER. THE IMPLEMENTATION OF AN ALTERNATE IN-HOUSE WATER PURIFICATION SYSTEM AND THE USE OF SARTORIUS FILTERS IN THE PRODUCTION OF DILUENT/SHEATH REAGENT MINIMIZED POST-SHIP PLATELET BACKGROUND COUNT ISSUES IN DILUENT/SHEATH REAGENT. THE CORRECTIVE/PREVENTIVE ACTION PLAN INCLUDED AN UPGRADE TO THE SITE MANUFACTURING WATER PURIFICATION SYSTEM TO IMPROVE THE ABILITY OF THE SYSTEM TO REMOVE ORGANIC COMPOUNDS. PRODUCT LABELING INSTRUCTS THE CUSTOMER NOT TO RUN PT SAMPLES IF PLATELET BACKGROUNDS ARE ELEVATED. IF THE CUSTOMER DOES NOT FOLLOW LABELING INSTRUCTIONS AND PT SAMPLES ARE RUN WHEN BACKGROUND COUNTS ARE UNACCEPTABLE, PHYSICIANS COULD MAKE TREATMENT DECISIONS BASED ON INCORRECT PLATELET RESULTS. AS A RESULT OF AN OBSERVATION DURING A FDA INSPECTION CONDUCTED NOVEMBER 13, 2006 THROUGH DECEMBER 7, 2006, ABBOTT DIAGNOSTICS DIVISION PERFORMED A COMPREHENSIVE REVIEW OF ALL REPORTABLE CORRECTIONS AND REMOVALS FOR 2006, AND FILED MDRS FOR THE COMPLAINTS AND REMEDIAL ACTIONS ASSOCIATED WITH THE ACTIONS TAKEN UNDER 21 CFR 806 WITH ONE EXCEPTION. ON DECEMBER 18, 2006 ABBOTT DIAGNOSTICS DIVISION SUBMITTED AN EXEMPTION FROM FILING INDIVIDUAL MDRS FOR THE COMPLAINTS ASSOCIATED WITH REMEDIAL ACTION INITIATED FOR CELL-DYN 4000, CELL DYN SAPPHIRE AND CELL-DYN 3200 SYSTEMS DILUENT SHEATH. ON SEPTEMBER 14, 2007 ABBOTT WAS GRANTED PERMISSION TO SUBMIT A ONE-TIME SUMMARY REPORT TO SATISFY MDR OBLIGATIONS FOR UNREPORTED MALFUNCTION EVENTS FOR THE PERIOD BEGINNING JANUARY 1, 2005 THROUGH JUNE 30, 2007. REFER TO THE ATTACHED SPREADSHEET FOR THE ADD'L REPORTABLE EVENTS ASSOCIATED WITH THIS MDR. THIS REPORT COVERS TOTAL MALFUNCTION MDRS BEING FILED FOR INTERACTION OF TRACE COMPOUNDS WITH THE DILUENT/SHEATH FORMULATION WHICH MAY CAUSE HIGH PLATELET BACKGROUND READINGS ON THE CELL-DYN 4000, CELL-DYN SAPPHIRE AND CELL-DYN 3200 HEMATOLOGY ANALYZERS. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THIS MEDWATCH REPORT IS BEING FILED DUE TO THE FINDING OF TRACE ORGANIC CONTAMINANTS BEING INTRODUCED TO THE PRODUCT (CELL-DYN 4000/CELL-DYN SAPPHIRE AND CELL-DYN 3200 DILUENT SHEATH) THROUGH THE MANUFACTURING WATER SYSTEM. THE INTERACTION OF TRACE COMPOUNDS WITH THE DILUENT/SHEATH FORMULATION MAY CAUSE HIGH PLATELET BACKGROUND READINGS ON THE CELL-DYN 4000,CELL-DYN SAPPHIRE AND CELL-DYN 3200 HEMATOLOGY ANALYZERS. THERE HAVE BEEN NO REPORTED INJURIES RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CDSAPPHIRE, CD4000, CD3200 DILUENT SHEATH DILUENT SHEATH FOR USE ON THE CD SAPPHIRE, CD4000, CD3200 HEMATOLOGY SYSTEMS GKZ ABBOTT DIAGNOSTICS DIVISION/CELL DYN NA 52837I2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR CELL-DYN 3200 ANALYZER| CELL-DYN SAPPHIRE| CELL-DYN 4000 ANALYZER