BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD

    MDR report key: 3100364 · Received May 8, 2013

    Report

    Report Number
    2919069-2013-00041
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 22, 2013
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INCLUDED REVIEWS OF PRODUCT HISTORICAL DATA AND PRODUCT LABELING. QUALITY CONTROL AND WHOLE BLOOD PRECISION PASSED EXPECTED SPECIFICATIONS. THE SUBMITTED DATA SHOWED RESULTS OF THE REPEAT RUNS WERE CONSISTENT AND ALIGNED WITH THE INITIAL RESULT. THE POSSIBILITY OF A COMPROMISED AND POOR SAMPLE DRAW CANNOT BE ELIMINATED. THE CELLDYN EMERALD OPERATIONS MANUAL WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ISSUES WERE IDENTIFIED. THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION/DEFICIENCY.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT A LOW PLATELET RESULT WAS GENERATED BY THE CELLDYN EMERALD ANALYZER ON A CHEMOTHERAPY PATIENT. A RESULT OF AROUND 18,000/UL WAS GENERATED ON A SAMPLE FROM (B)(6) 2013. THE EXPECTED VALUE FOR THE PATIENT WAS AROUND 34,000/UL. THE PATIENT WAS REDRAWN ON (B)(6) 2013 AND A PLATELET RESULT OF 38,000/UL WAS GENERATED. THE CUSTOMER INDICATED THAT THEY HAD DIFFICULTIES DRAWING THE PATIENT'S BLOOD ON THE FIRST SAMPLE AND THE FILL VOLUME WAS LESS THAN NORMAL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200475 CELL-DYN EMERALD GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1