BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 2101330 · Received May 24, 2011

    Report

    Report Number
    2919069-2011-00223
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    May 7, 2011
    Report Date
    May 9, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2011, AN ABBOTT CUSTOMER TECHNICAL ADVOCATE (CTA) FOLLOWED UP WITH THE CUSTOMER. THE CUSTOMER STATED THE INSTRUMENT WAS RUNNING FINE AND NO PATIENTS WITH DISCREPANT RESULTS WERE FOUND. NO FURTHER DATA WAS PROVIDED BY THE CUSTOMER. THE CELL-DYN SAPPHIRE SYSTEM OPERATOR'S MANUAL, PART NUMBER 9140426, REVISION A, CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. REVIEW OF COMPLAINT TRACKING AND TRENDING.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A PATIENT RECEIVING CHEMOTHERAPY GENERATED A CELL-DYN SAPPHIRE WBC COUNT OF 1.9 K/UL. THIS VALUE WAS NOT FLAGGED; HOWEVER, THE DIFFERENTIAL WAS FLAGGED WITH IG/BAND. THE CUSTOMER RELEASED THE WBC COUNT AND HELD THE DIFFERENTIAL RESULTS PENDING A MANUAL SLIDE REVIEW. UPON REVIEW OF THE SLIDE, THE CUSTOMER NOTED THAT THE WBC GENERATED COUNT OF 1.9 K/UL SEEMED TOO HIGH COMPARED TO THE ESTIMATE MADE ON THE SLIDE REVIEW. THE CUSTOMER THEN PROCEEDED TO RETEST THIS PATIENT SAMPLE ON A SECOND CELL-DYN SAPPHIRE ANALYZER IN THE LAB, WHICH GENERATED A RESULT OF 0.165 K/UL THAT THE CUSTOMER STATED IS THE CORRECT RESULT. CONTROLS WERE WITHIN SPECIFICATIONS ON ALL RUNS. THE CUSTOMER STATED THAT THERE WERE NO OTHER ISSUES WITH ANY OTHER PATIENT SAMPLES. THE CUSTOMER DECLINED ANY FURTHER ASSISTANCE AS THEY BELIEVE THE ANALYZERS ARE OPERATING AS EXPECTED. THERE IS 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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR