BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD INSTRUMENT

    MDR report key: 21249039 · Received January 27, 2025

    Report

    Report Number
    2919069-2025-00002
    Event Type
    Malfunction
    Date Received
    January 27, 2025
    Date of Event
    January 7, 2025
    Report Date
    February 20, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740020088
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION SECTION H4 - DEVICE MFG DATE: UPDATED FROM BLANK TO 9/18/2023. THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND DECONTAMINATED IT WHICH RESOLVED THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. A REVIEW OF TRACKING AND TRENDING FOR THE CELL-DYN EMERALD DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE CELL-DYN EMERALD FOR SERIAL (B)(6) WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED PLATELET (PLT) RESULTS GENERATED ON THE CELL-DYN EMERALD THAT DO NOT MATCH THE PATIENT¿S CLINICAL HISTORY. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 140 ¿ 440 K/UL): SAMPLE ID (B)(6) INITIAL RESULT = 76 K/UL, REPEAT RESULT AT ANOTHER LAB ON ANOTHER CELL-DYN EMERALD = 20 K/UL, REPEAT RESULT AT ANOTHER LAB ON BECKMAN COULTER = 9 K/UL. IT WAS NOTED THAT THE CUSTOMER BELIEVES THAT THE RESULTS OF 20 AND 9 ARE CORRECT AS THEY MATCH THE PATIENT¿S CLINICAL HISTORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED PLATELET (PLT) RESULTS GENERATED ON THE CELL-DYN EMERALD THAT DO NOT MATCH THE PATIENT¿S CLINICAL HISTORY. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 140 ¿ 440 K/UL): SAMPLE ID (B)(6) INITIAL RESULT = 76 K/UL, REPEAT RESULT AT ANOTHER LAB ON ANOTHER CELL-DYN EMERALD = 20 K/UL, REPEAT RESULT AT ANOTHER LAB ON BECKMAN COULTER = 9 K/UL IT WAS NOTED THAT THE CUSTOMER BELIEVES THAT THE RESULTS OF 20 AND 9 ARE CORRECT AS THEY MATCH THE PATIENT¿S CLINICAL HISTORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607259 CELL-DYN EMERALD INSTRUMENT COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740020088

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown