BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 2082434 · Received May 10, 2011

    Report

    Report Number
    2919069-2011-00197
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), CUSTOMER BARCODE DID NOT MEET RECOMMENDED SPECIFICATIONS ONE (1) BARCODE READER AND ONE (1) BARCODE LABEL WERE SENT FOR THE INVESTIGATION. FLOW CYTOMETRY STANDARD (FCS) FILES, OPERATING SOFTWARE (AOS LOG) LOG FILES, AND INTERNAL LOG FILES WERE PROVIDED TO AID WITH THE INVESTIGATION ON (B)(4) 2011. THE RETURNED BARCODE LABEL WAS CHECKED AND COMPARED TO THE BAR CODE SPECIFICATIONS IN THE CELL-DYN SAPPHIRE SYSTEM OPERATOR'S MANUAL UNDER SECTION 4: PERFORMANCE CHARACTERISTICS AND SPECIFICATIONS, SUBSECTION: BAR CODE SPECIFICATIONS, PAGE 4-9. THE SUBMITTED BARCODE LABEL FAILED TO MEET THE PRODUCT SPECIFICATION BECAUSE THE MINIMUM QUIET ZONE IS 5 MM. THE QUIET ZONES IN THE RETURNED BARCODE LABEL WERE 3.81 MM AND 4.54 MM. THE LABEL LENGTH, SYMBOL LENGTH, BARCODE HEIGHT, AND LABEL WIDTH WERE WITHIN THE BAR CODE LABEL SPECIFICATIONS. A VISUAL INSPECTION OF THE LABEL SHOWED THAT THE QUALITY OF THE PAPER USED FOR THE BARCODE LABEL WAS A BIT SHINY; HOWEVER, IT DID NOT INTERFERE WITH TESTING. THE INFORMATION DOCUMENTED IN THE TICKET STATES THAT THERE IS AN INCREASE OF SUNLIGHT IN THE LAB. THE CUSTOMER SUSPECTED THAT THE LIGHT PATH SHINING ON THE SAMPLE LOADER AND THE SHINY BARCODE LABELS MAY HAVE CONTRIBUTED TO THE INCORRECT BARCODE READ. THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED SOME TROUBLESHOOTING AND BLOCKING THE LIGHT PATHWAY APPEARED TO RESOLVE THE ISSUE AND SAMPLES WERE READ CORRECTLY. THE SUBMITTED ELECTRONIC DATA WERE SUBMITTED FOR REVIEW BY A SUBJECT MATTER EXPERT (SME). THE SME STATED THAT BASED ON THE AOS LOG FILE, THE BARCODE READER REPORTED A "(B)(4)" INSTEAD OF (B)(4) FOR THE FIRST 4 CHARACTERS LIKE ALL OTHER BARCODE LABELS IN THE LOG FILE. THE BARCODE READER REPORTED VALUES FROM AOS LOG FILE: ((B)(4)). WITHIN THE ATTACHED AOS LOG FILE, THERE WERE 185 BARCODE READ ATTEMPTS AND 14 OF THEM WERE NOT SUCCESSFUL READS. FOR THIS LIMITED DATA SET BARCODE READ FAILURE RATE IS 7.6%. BASED ON THE ATTACHED DATALOG PRINTOUT, USER MANUALLY UPDATES THE SPECIMEN IDS NOT READ BY THE BARCODE READER. LIKE THE SPECIMEN ID FOR THE SEQUENCE NUMBER (B)(4) COULD NOT BE READ BY THE BARCODE READER AND MANUALLY FIXED BY THE USER. THE SME STATED THAT THE ISSUE MAY BE RELATED TO THE BARCODE READER OR THE ALIGNMENT OF THE BARCODE READER. THE SME REQUESTED FOR THE BARCODE READER TO BE REPLACED AND RETURN FOR FURTHER INVESTIGATION TOGETHER WITH THE BARCODE LABEL. THE BARCODE READER AND BARCODE LABELS WERE RECEIVED ON (B)(4) 2011. THE RETURNED BARCODE READER AND BARCODE LABEL WERE TESTED USING THE BARCODE LABEL PRE-APPROVED PROTOCOL, REV. 01 AND THE BARCODE READER OF A REFERENCED CELL-DYN SAPPHIRE, SERIAL NUMBER (B)(4), AND SOFTWARE VERSION V4. THE REFERENCE BARCODE READER AND THE RETURN BARCODE READER SUCCESSFULLY READ ALL 20 BARCODE LABELS, WHICH INCLUDED THE RETURN BARCODE LABEL DURING TESTING. THE COMPLAINT ISSUE OF FALSE BARCODE READING COULD NOT BE VERIFIED. THE SME STATED THAT IF THE ISSUE COULD NOT BE VERIFIED USING THE RETURNED BARCODE READER AND BARCODE LABEL, THEN IT MAY BE POSSIBLE THAT THE LIGHT PATHWAY MAY HAVE AFFECTED THE READ. IF THE CUSTOMER IS RUNNING THE INSTRUMENT WITHOUT COVER, THE EXCESSIVE LIGHT COULD FAIL THE BARCODE READER AND NOT BE ABLE TO READ BARCODE LABELS OR IN THIS CASE, CAUSE AN INCORRECT BARCODE LABEL READ. THE TECHNICAL SERVICES SPECIALIST (TSS) REVIEWED THE COMPLAINT INCIDENT RELATED TO POSSIBLE EFFECT OF EXCESSIVE LIGHT PATH. THE TSS EXPLAINED THAT BY DESIGN THE AMOUNT OF LIGHT GETTING INTO THE SYSTEM IS CONTROLLED BY THE COVERS. THE BARCODE READER IS NOT ONLY ENCLOSED WITHIN THE MAIN COVERS, BUT ALSO THE CENTER COVERS OF THE AUTOLOADER ASSEMBLY. WITH ALL THE COVERS AND THE RACKS IN PLACE, THE ONLY LIGHT THAT IT WOULD RECEIVE IS THE LIGHT GENERATED FROM THE BARCODE READER TO READ THE BARCODE LABELS ON THE SAMPLE TUBES. THE PRINT QUALITY OF THE BARCODE LABEL ALONG WITH THE ALIGNMENT OF THE BARCODE READER CAN AFFECT READING OF THE BARCODE LABELS. IF THE REFLECTIVE CONTRAST OF THE LABEL BACKGROUND IS GREATER THAN THE CONTRAST OF THE BARS, THE READINGS OF THE BARCODE LABELS ARE IMPACTED. THE TSS REFERRED TO THE SPECIFICATIONS STATED IN THE CELL-DYN SAPPHIRE SYSTEM OPERATOR'S MANUAL. A REVIEW OF COMPLAINT ANALYSIS TRENDING SYSTEM AND TRENDING ANALYSIS SUPPORT ANALYSIS REPORTS FOR THE MONTHS OF (B)(4) 2011 THROUGH (B)(4) 2011 FOUND NO ADVERSE TREND FOR LIST NUMBER 08H00-01 RELATED TO THIS COMPLAINT ISSUE. BASED ON THIS INVESTIGATION, A PRODUCT DEFICIENCY WAS NOT BE IDENTIFIED FOR THE CELL-DYN SAPPHIRE ANALYZER, L/N 08H00-01.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE ACCOUNT NOTICED THE CELL-DYN SAPPHIRE ANALYZER WAS MISREADING BARCODE LABELS. THE ACCOUNT PROVIDED AN EXAMPLE OF A BARCODE MISREAD OF (B)(4) INSTEAD OF THE CORRECT NUMBER (B)(4). THE ACCOUNT MENTIONED THE BARCODE LABEL PAPER IS A BIT SHINY. THE ACCOUNT PREVENTED A LIGHT PATHWAY ON THE SAMPLE LOADER WITH IMPROVEMENT. THE BARCODE READER IS CONFIGURED FOR CODE 128 WITH CHECK DIGIT. NO RESULTS WERE REPORTED OUTSIDE THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1