BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 3756029 · Received April 17, 2014

    Report

    Report Number
    2919069-2014-00018
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 24, 2014
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K061667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED BAR CODE READER (BCR), BARCODE LABELS, AND FLEX PS2 KEYBOARD WERE EVALUATED. THE BARCODE LABELS WERE MEASURED FOLLOWING THE BARCODE LABEL SPECIFICATIONS STATED IN THE CELLDYN RUBY MANUAL. THE MEASUREMENT RESULTS SHOWED THE BARCODE LABELS FAILED ON THE FOLLOWING SPECIFICATIONS: A. MAXIMUM LABEL LENGTH = 63.4 MM (MAXIMUM IS 51 MM) B. MINIMUM BAR CODE HEIGHT = 8.55 MM ( MINIMUM IS 12.7 MM) C. LEFT QUIET ZONE = 4.10 MM (MIN 5 MM) ANALYSIS OF THE RETURNED PRODUCTS, BAR CODE READER, BARCODE LABELS, AND FLEX PS2 KEYBOARD, WERE PERFORMED ON THE REFERENCE CD RUBY ANALYZER, SERIAL NUMBER (B)(4). THE VERIFICATION OF SUBMITTED BCR AND BARCODE LABELS WAS UNABLE TO VERIFY THE COMPLAINT INCIDENT OF TRUNCATED SPECIMEN ID WHEN THE HAND-HELD BCR WAS USED. HOWEVER, THE POSSIBILITY THAT THE OUT OF SPECIFICATION BARCODE LABELS MAY HAVE CONTRIBUTED TO THE INCIDENT COULD NOT BE ELIMINATED. THE BCR HAD TO BE CENTERED CORRECTLY TO THE LABELS IN ORDER TO BE EFFICIENTLY READ. THE RETURNED FLEX PS2 KEYBOARD WAS EXAMINED AND VERIFIED. THERE WERE NO ISSUES FOUND WITH THE KEYBOARD AND IT PERFORMED AS EXPECTED. ALL KEYS WERE WORKING AND THE CD RUBY INSTRUMENT ACCEPTED ALL THE KEYBOARD ENTRIES. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE CELL-DYN RUBY MANUAL WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION / DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE CELL DYN RUBY ANALYZER IS NOT SCANNING BARCODES COMPLETELY. WHEN THE BARCODE IS SCANNED THE NUMBERS ARE NOT COMPLETE. FOR EXAMPLE, SAMPLE ID 1800084 WILL BE READ AS 800084 THE CUSTOMER PROVIDED TWO ADDITIONAL EXAMPLES: ON (B)(6) 2014, THE CUSTOMER ATTEMPTED TO SCAN BARCODE 18544 WITH HANDHELD (H-H) SCANNER. CUSTOMER SCANNED THE BARCODE SEVERAL TIMES AND GOT THE FOLLOWING READS: 8544, 8544, 44, 44. CUSTOMER CYCLED POWER TO ANALYZER AND RESCANNED BARCODE WITH H-H AND WAS ABLE TO GET CORRECT SCAN OF 18544. ON (B)(6) 2014, THE CUSTOMER RAN SAMPLE 19065 IN CLOSED MODE. CUSTOMER GOT NO ID READ ERROR, WAS UNABLE TO EDIT ID SO ATTEMPTED TO SCAN WITH H-H SCANNER - READ AS 9065. CUSTOMER CYCLED POWER AND WAS ABLE TO SCAN WITH H-H SCANNER CORRECTLY. THE CUSTOMER WAS UNABLE TO VERIFY IF MISREADS WERE OCCURRING ON INTERNAL SCANNER. THE CUSTOMER STATES THEY DO NOT CLEAN BARCODE WINDOWS. SAMPLES WITH INCOMPLETE BARCODES WERE NOT REPORTED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234769 CELL-DYN RUBY ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1