BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD

    MDR report key: 7635007 · Received June 25, 2018

    Report

    Report Number
    2919069-2018-00032
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    June 13, 2018
    Report Date
    July 2, 2018
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    UDI-DI
    00380740020088
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, FIELD SERVICE REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE CUSTOMER DATA INDICATED THAT THE RESULTS GENERATED FLAGS WHICH ALERT THE OPERATOR TO VERIFY THE RESULTS. FIELD SERVICE EVALUATED THE ANALYZER AND COMPLETED PREVENTATIVE MAINTENANCE. NO ADDITIONAL ISSUES HAVE BEEN DOCUMENTED SINCE COMPLETION OF MAINTENANCE. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF CELL-DYN EMERALD ANALYZER, LIST NUMBER 09H39 WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY ELEVATED PLATELET RESULT WHILE USING THE CELL-DYN EMERALD ANALYZER. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS DATA (NORMAL RANGE IS 140-440 K/UL) ON (B)(6) 2018: SID (B)(6) : INITIAL 1136, RETEST 335 10E3/UL. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO ADDITIONAL PATIENT INFORMATION WAS MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478104 CELL-DYN EMERALD AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION 00380740020088

    Patients

    Seq Age Sex Outcome Treatment
    1