BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD

    MDR report key: 3902970 · Received June 30, 2014

    Report

    Report Number
    2919069-2014-00036
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DURING TROUBLESHOOTING, THE FIELD SERVICE REPRESENTATIVE (FSR) FOUND THE TUBING WAS VERY CRIMPED DUE TO THE PLASTIC WRAPPING AROUND THE TUBING. THE FSR INSTALLED THE SAMPLE SHEATH AND TUBING 21. REPLACEMENT OF THE SAMPLING SHEATH AND TUBING 21 RESOLVED THE PLATELET (PLT) COMPLAINT ISSUE. THE CELL-DYN EMERALD SYSTEM OPERATOR'S MANUAL PROVIDES INFORMATION AND TROUBLESHOOTING GUIDES TO ASSIST CUSTOMERS FOR ANY DATA-RELATED PROBLEMS. BASED ON THE INVESTIGATION, WHICH INCLUDED REVIEW OF PRODUCT HISTORICAL DATA AND LABELING, A PRODUCT ISSUE WAS NOT DETERMINED FOR THE CD EMERALD SYSTEM, LIST NUMBER 09H39-01.

    Description of Event or Problem · 1

    THE ACCOUNT NOTICED FALSE ELEVATED PLT > 1000 10^3/UL ON PATIENT SAMPLES PROCESSED ON THE CELL-DYN EMERALD THAT REPEATED IN NORMAL RANGE OF 140 - 400 10^3/UL AT ANOTHER LABORATORY. TWO EXAMPLES WERE PROVIDED. ID: (B)(6) GENERATED CELL-DYN EMERALD PLT = 1002 10^3/UL WITH FLAGS OF LUEKOCYTOSIS, LYMPHOPENIA, GRANULOCYTOSIS AND THROMBOCYTOSIS. ID (B)(6) GENERATED CELL-DYN EMERALD PLT = 969 AND 1128 10^3/UL WITH FLAGS OF INVALID WBC AND DIFFERENTIAL COUNT, LYMPHOCYTOSIS, GRANULOCYTOPENIA, ERYTHROCYTOSIS, THOMBOCYTOSIS, AND PLATELET AGGREGATES. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379761 CELL-DYN EMERALD AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1