BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 1192663 · Received October 10, 2008

    Report

    Report Number
    2919069-2008-00725
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K061667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    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): A SET OF ELEVEN BARCODES WERE RECEIVED FROM THE CUSTOMER, BUT NONE OF THE BARCODE LABELS WAS THE ACTUAL PROBLEM BARCODE LABEL. BARCODE LABELS OUT OF SPECIFICATION. ON (B)(4) 2008, A SET OF ELEVEN (11) BARCODE LABELS FROM THE CUSTOMER WAS RECEIVED, BUT NONE OF THE LABELS WERE THE ACTUAL PROBLEM BARCODE LABEL. USING A RULER, CALIBRATED IN MILLIMETERS, IT WAS OBSERVED THAT THE BARCODES RECEIVED FROM THE CUSTOMER DID NOT MEET 2 OF THE 5 REQUIREMENTS OF THE SPECIFICATION IN THE CELL-DYN SYSTEM OPERATOR'S MANUAL, LIST NUMBER 08H56-03, REVISION C, UNDER SECTION 4, PAGES 4-7 AND 4-8, BARCODE SPECIFICATIONS. THE SPECIFICATION FOR THE QUIET ZONE IN THE BARCODE LABEL IS A MINIMUM OF 5 MM. THE CUSTOMER'S MEASURED 4 MM. THE REQUIRED BARCODE LABEL HEIGHT IS A MINIMUM OF 12.7 MM. THE CUSTOMER'S BARCODE LABEL MEASURED 10 MM. USING A QUICK-CHECK 850 BARCODE SCANNER, ALL BARCODES READ CORRECTLY AND WERE RATED A. THE BARCODES ARE USING CODE 39 WITHOUT CHECK DIGITS. ONE BARCODE (2185447) WAS PRINTED SLIGHTLY LOPSIDED AND HAD A LOWER RATING, BUT STILL READ CORRECTLY. AFTER CREATING TWO BARCODES USING CODE 39 WITHOUT CHECK DIGITS, THESE BARCODES WERE SCANNED 10 TIMES ON 3 DIFFERENT CELL-DYN RUBY INSTRUMENTS. THERE WERE NO MISREADS. WITHOUT THE ACTUAL PROBLEM BARCODE LABELS, IT IS NOT POSSIBLE TO CONCLUDE THE ROOT CAUSE FOR THE REPORTED ISSUE; HOWEVER, INVESTIGATION SHOWED THAT THE RETURNED BARCODE LABELS FROM THE CUSTOMER DID NOT MEET SPECIFICATION. CODE 39 LABELS GIVE A HIGHER LEVEL OF PROTECTION IF CHECK DIGITS ARE USED. A REVIEW OF COMPLAINT TRACKING AND TRENDING REPORTS FOR THE TIMEPERIOD OF (B)(4) 2008 THROUGH (B)(4) 2008 DID NOT INDICATE ANY ADVERSE TREND FOR THE CELL-DYN RUBY, LIST NUMBER 08H67-01, RELATED TO THE COMPLAINT ISSUE. THERE WAS NO SYSTEMIC ISSUE IDENTIFIED FOR THE CELL-DYN RUBY PRODUCT THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A PATIENT SAMPLE WITH BARCODE WAS SCANNED USING THE HAND HELD BARCODE READER AND TESTED ON THE CELL-DYN RUBY ANALYZER IN OPEN MODE. WHEN THE CUSTOMER LATER VIEWED THE RESULTS ON THE ANALYZER SCREEN, SHE NOTICED THAT THERE WERE NO PATIENT DEMOGRAPHICS. SHE THEN REALIZED THAT THE SAMPLE ID HAD BEEN INCORRECTLY READ BY THE BARCODE READER. THE CUSTOMER COULD NOT REPRODUCE THE ERROR. NO MISMATCHED RESULTS WERE 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 RUBY ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI