BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 3910558 · Received July 2, 2014

    Report

    Report Number
    2919069-2014-00037
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 8, 2014
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE COMPLAINT TICKET AND DATA SUBMITTED WAS REVIEWED. THE FOLLOWING POSSIBLE CAUSES WERE IDENTIFIED. 1) THE PATIENT SAMPLE MAY HAVE HAD UNDERLYING RBC DISORDERS WHICH RENDER THE RBCS IN THE SPECIMEN PARTIALLY RESISTANT TO LYSING REGIMEN; THEREFORE, NOT ALL RBCS MAY HAVE BEEN PROPERLY LYSED AND RESULTED IN A HIGH WBC VALUE. 2) THE AMOUNT OF RESISTANT RBCS MAY HAVE BEEN AT THE BORDERLINE OF THE SYSTEM'S RSTRBC FLAGGING CRITERIA AND MAY HAVE RESULTED IN THE RESISTANT RBCS BEING MISSED AND MISCLASSIFIED. THE COMPLAINT INFORMATION STATED THAT THE BACKGROUND AND QC RUNS WERE ALL WITHIN SPECIFICATION AND ASSAY RANGES. SUBMITTED MOVING AVERAGE PROGRAM (MAP) DATA SHOWED THE INSTRUMENT IS OPTIMIZED AND PERFORMING WELL WITHIN THE EXPECTED TARGET CHANNELS. THE ISSUE WAS SPECIFIC TO THE PATHOLOGICAL SAMPLE CONTAINING INTERFERING SUBSTANCES AND CONDITIONS WHICH AFFECTED SAMPLE PROCESSING. THE CELL-DYN SAPPHIRE SYSTEM OPERATOR'S MANUAL, PROVIDES ADEQUATE INFORMATION RELATED TO INTERFERING SUBSTANCES AND CONDITIONS, LIMITATIONS OF RESULT INTERPRETATIONS, AND TROUBLESHOOTING GUIDES FOR DATA-RELATED ISSUES. THE INVESTIGATION INCLUDED REVIEW OF PRODUCT HISTORICAL DATA, LABELING, AND CONSULTATION WITH TECHNICAL SERVICES AND MEDICAL AFFAIRS TEAMS. IT WAS CONCLUDED THAT NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE CELL-DYN SAPPHIRE SYSTEM, LIST NUMBER 08H00-01, RELATED TO THE COMPLAINT INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY ELEVATED WBC RESULT OF 43.5 K/UL FOR A PATIENT SAMPLE (ID (B)(6)) TESTED ON THE CELL-DYN SAPPHIRE ANALYZER, SERIAL NUMBER (B)(4), ON (B)(6) 2014. THE SAME SAMPLE RETESTED AT 21.5 K/UL ON A DIFFERENT CELL-DYN SAPPHIRE ANALYZER. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387653 CELL-DYN SAPPHIRE ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1