BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD ANALYZER

    MDR report key: 8591172 · Received May 8, 2019

    Report

    Report Number
    2919069-2019-00058
    Event Type
    Malfunction
    Date Received
    May 8, 2019
    Report Date
    May 8, 2019
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    UDI-DI
    00380740020088
    PMA / PMN Number
    K081495
    Removal / Correction Number
    2919069-2/20/2019-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ABBOTT LABORATORIES DETERMINED THAT THE CELL-DYN EMERALD RBC COUNTING HEAD PERFORMANCE DETERIORATES OVER TIME RESULTING IN QC OUT OF RANGE LOW DUE TO DEPOSIT/BUILD-UP ON THE RBC COUNTING HEAD APERTURE CAUSED BY THE COMBINATION OF MULTIPLE FACTORS. THE PREVENTIVE MAINTENANCE SPECIFIED IN THE CELL-DYN EMERALD OPERATORS MANUAL AND ASSOCIATED CLEANING METHODS ARE NOT SUFFICIENT FOR APPROXIMATELY 5% OF USERS TO MAINTAIN THE CELL-DYN EMERALD SYSTEM OPERATIONAL ON A ROUTINE BASIS. THIS PRODUCT CORRECTION IS ASSOCIATED WITH CELL-DYN EMERALD INSTRUMENTS WITH SERIAL NUMBERS BELOW (B)(4). A PRODUCT CORRECTION LETTER WAS ISSUED ON FEBRUARY 20, 2019 TO ALL CELL-DYN EMERALD CUSTOMERS WITH IMPACTED SERIAL NUMBERS. THE LETTER INFORMS THE CUSTOMER OF THE ISSUE REGARDING RBC COUNTING HEAD PERFORMANCE DETERIORATION RESULTING IN QC OUT OF RANGE LOW AND PROVIDES THE CUSTOMER WITH NECESSARY ACTIONS REGARDING CELL-DYN EMERALD CLEANING AND FREQUENCY. NEW CUSTOMERS WILL RECEIVE THE UPDATED OPERATORS MANUAL, WHICH INCLUDES REVISED LABELING, UPON INSTALL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE QUALITY CONTROLS (QCS) WERE OUT OF RANGE LOW FOR PLATELETS WHILE USING THE CELL-DYN EMERALD ANALYZER. THERE WAS NO PATIENT INVOLVEMENT AND NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385119 CELL-DYN EMERALD ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION 00380740020088

    Patients

    Seq Age Sex Outcome Treatment
    1