BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 1260447 · Received December 12, 2008

    Report

    Report Number
    2919069-2008-00822
    Event Type
    Malfunction
    Date Received
    December 12, 2008
    Date of Event
    November 18, 2008
    Report Date
    November 18, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON 11/20/2008, THE FIELD SERVICE REPRESENTATIVE (FSR) ATTEMPTED TO REPRODUCE THE PROBLEM WITHOUT SUCCESS. THE FSR REMOVED AND CLEANED THE BAR CODE READER AND THE AREA AROUND IT DUE TO THE PRESENCE OF DUST FILAMENTS IN FRONT OF THE READ WINDOW. THE BAR CODE WAS TESTED AND PASSED INSPECTION. THERE WAS NO REPORT OF AFFECTED PATIENT MANAGEMENT. THERE WAS NO PRODUCT RETURN OR DATA SUBMITTED. THE CELL- DYN SAPPHIRE SYSTEM OPERATOR'S MANUAL, LIST NUMBER 08H10-02, REVISION D, UNDER SECTION 9, SERVICE AND MAINTENANCE PROCEDURES, PAGES 9-50 THROUGH 9-52, DESCRIBES THE PROCEDURE FOR CLEANING THE BAR CODE READER WINDOW. THE MANUAL STATES THAT THE BAR CODE READER WINDOW SHOULD BE CLEANED AS PART OF TROUBLESHOOTING BAR CODE MISREAD. DUST OR DEBRIS CAN "BLIND" THE SENSOR CAUSING THE READER TO MISREAD A LABEL. THE ACTUAL BAR CODE LABEL WAS NOT SUBMITTED FOR INVESTIGATION; THEREFORE, THE BAR CODE CONFIGURATION AND BAR CODE SYMBOLOGY ARE UNKNOWN. THE INFORMATION PROVIDED STATED THAT THE BAR CODE USED IN THE LAB HAD NO CHECKSUM (CHECK DIGIT). CHECK DIGIT IS AN EXTRA NUMERIC CHARACTER IN THE BAR CODE THAT PERMITS THE SCANNING DEVICE TO MATHEMATICALLY DETERMINE WHETHER IT READ THE CODE CORRECTLY. THE CHECK DIGIT HELPS DECREASE BAR CODE LABEL MISREADS. SECTION 2, INSTALLATION PROCEDURES AND SPECIAL REQUIREMENTS, CUSTOMIZING THE SYSTEM FOR BAR CODES, PAGE 2-102, INDICATES THAT THE BAR CODE READER IN THE CELL-DYN SAPPHIRE AUTOLOADER CAN BE CUSTOMIZED TO CALCULATE A CHECK CHARACTER/DIGIT IF ONE IS IN THE BAR CODE SYMBOLOGY. THE OPERATOR CAN SETUP, VERIFY, OR CHANGE THE CHECK CHARACTER/DIGIT SETTINGS FOR THE AUTOLOADER BAR CODE READER. CODE 128 SYMBOLOGY ALWAYS USES A CHECK DIGIT AND THE OPTION TO CUSTOMIZE IS NOT AVAILABLE. A REVIEW OF THE DOMESTIC AND INTERNATIONAL COMPLAINT ANALYSIS TRENDING SYSTEM (CATS) AND TRENDING ANALYSIS SUPPORT SYSTEM'S (TASS) TREND ANALYSIS REPORTS ON THE MTRS DATABASE ON LIST BASE 08H00-01, FOR THE MONTHS OF (B)(6) 2008 DID NOT INDICATE AN ADVERSE TREND FOR THE REPORTED ISSUE. BASED ON THIS INVESTIGATION, NO PRODUCT DEFICIENCY/MALFUNCTION WAS IDENTIFIED FOR THE CELL-DYN SAPPHIRE SYSTEM, LIST NUMBER 08H00-01, FOR THE REPORTED ISSUE. THIS IS THE FINAL REPORT.

    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 ACCOUNT STATED THAT THE CELL-DYN SAPPHIRE ANALYZER INCORRECTLY READ THE BARCODE ON A SAMPLE THE SAMPLE HAD A BARCODE ID OF 935 AND THE SAPPHIRE READ THE SAMPLE AS 955. UPON READING THE SAMPLE AGAIN IT WAS CORRECTLY READ AS 935. THE FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED AND CLEANED THE BARCODE READER, AND THE AREA AROUND IT AS THERE WAS THE PRESENCE OF DUST IN FRONT OF THE READING WINDOW. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1