BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 1293516 · Received January 26, 2009

    Report

    Report Number
    2919069-2009-00019
    Event Type
    Malfunction
    Date Received
    January 26, 2009
    Date of Event
    January 14, 2009
    Report Date
    January 14, 2009
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). CD DILUENT LIST NUMBER 99220-02, CD DETERGENT DIFF LIST NUMBER 99320-01. EVALUATION RESULTS: DIRTY APERTURE PLATES. IN RESPONSE TO THIS ISSUE AN INVESTIGATION WAS INITIATED TO FURTHER EXAMINE THE CUSTOMER'S ISSUE. THE INVESTIGATION INCLUDED A REVIEW OF THE COMPLAINT TEXT, INSTRUMENT MAINTENANCE HISTORY, A REVIEW OF LABELING, AND A SEARCH FOR SIMILAR COMPLAINTS. ON (B)(6) 2009, A FIELD SERVICE REPRESENTATIVE (FSR) VISITED THE CUSTOMER'S SITE TO INSPECT THE CELL-DYN 1800 INSTRUMENT. UPON COMPLETION OF THE INSPECTION, THE FSR CLEANED THE APERTURE PLATES AND RAN A PRECISION, WHICH PASSED. THESE ACTIONS RESOLVED THE HIGH PLT ISSUE THAT THE CUSTOMER HAD REPORTED, AND THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. THE CELL-DYN 1800 SYSTEM OPERATOR'S MANUAL, LIST NUMBER 07H80-01, REVISION E, UNDER SECTION 10, TROUBLESHOOTING AND DIAGNOSTICS, PAGES 10-11 THROUGH 10-13, PROVIDES INFORMATION TO ASSIST IN PROBLEM IDENTIFICATION, ISOLATION, AND CORRECTIVE ACTIONS. INSTRUCTIONS FOR OBTAINING TECHNICAL ASSISTANCE ARE INCLUDED AS WELL. SECTION 9, SERVICE AND MAINTENANCE, PREVENTIVE MAINTENANCE SCHEDULE, PAGE 9-3, INDICATES THAT CLEANING/REPLACING THE APERTURE PLATES IS AN AS-REQUIRED PROCEDURE. SECTION 9, AS-REQUIRED MAINTENANCE, PAGE 9-43, PROVIDES INSTRUCTIONS ON CLEANING/REPLACEMENT OF THE APERTURE PLATES. TRACKING AND TRENDING FOR THE PERIOD (B)(6) 2008, DID NOT INDICATE ANY ADVERSE TREND FOR THE CELL-DYN 1800 FOR DISCREPANT PLT RESULTS ON PATIENT SAMPLES. BASED ON THE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED FOR THE CELL-DYN 1800 FOR DISCREPANT PLT RESULTS ON PATIENT SAMPLES. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A CELL-DYN 1800 ANALYZER GENERATED DISCREPANT PLATELET RESULTS FOR A PATIENT SAMPLE. THE PLATELET RESULTS WERE 40 K/UL ON THE CELL-DYN 1800, AND 10 K/UL ON A COULTER ANALYZER. THE PHYSICIAN QUESTIONED THE RESULTS GENERATED BY THE CELL-DYN ANALYZER BECAUSE THEY DID NOT AGREE WITH THE PATIENT'S CLINICAL PICTURE, AND NO ADVERSE 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 CD18 CNF HGB LYSE LIST NUMBER 7H84-01