BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD

    MDR report key: 6546521 · Received May 4, 2017

    Report

    Report Number
    2919069-2017-00082
    Event Type
    Malfunction
    Date Received
    May 4, 2017
    Report Date
    May 4, 2017
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    UDI-DI
    00380740020088
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INVESTIGATION WHICH INCLUDED REVIEWING HISTORICAL DATA, NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE CELL-DYN EMERALD INSTRUMENT, FOR THE COMPLAINT ISSUE. THE FIELD SERVICE REPRESENTATIVE (FSR) FOUND SYRINGE MOVEMENT WAS NOT AS EXPECTED ON THE CELL-DYN EMERALD. THE FSE FLUSHED AND LUBED THE SYRINGES WITH STABLE PRECISION. ADDITIONALLY, PREVENTATIVE MAINTENANCE WAS PERFORMED. REVIEW OF COMPLAINT INFORMATION FOUND QUALITY CONTROL (QC) WAS BIASED FOR HEMOGLOBIN (HGB) AND OUT OF RANGE HIGH FOR RED BLOOD CELL (RBC). A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. A REVIEW TO IDENTIFY ADVERSE TRENDS FOR A PRODUCT ISSUE RELATED TO THE COMPLAINT INCIDENT WAS NOT IDENTIFIED. USE ERROR MAY HAVE CONTRIBUTED TO THE CUSTOMER'S ISSUE AS PREVENTATIVE MAINTENANCE WAS NOT DONE ON THE INSTRUMENT SINCE JANUARY 2015. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED FALSELY ELEVATED HEMOGLOBIN ON 2 PATIENT SAMPLES PROCESSED ON THE CELL-DYN EMERALD. PATIENT 1 GENERATED CELL-DYN EMERALD HEMOGLOBIN OF 9.5 G/DL WITH A FINGERSTICK SAMPLE BUT THE PATIENT GENERATED HEMOGLOBIN OF 6.5 WITH A VENOUS AT ANOTHER FACILITY. PATIENT 2 GENERATED CELL-DYN EMERALD HEMOGLOBIN OF APPROXIMATELY 8 G/DL BUT THE PATIENT HISTORICALLY RUNS APPROXIMATELY 6.0 G/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327895 CELL-DYN EMERALD AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION 00380740020088

    Patients

    Seq Age Sex Outcome Treatment
    1