BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD INSTRUMENT

    MDR report key: 23464581 · Received November 4, 2025

    Report

    Report Number
    2919069-2025-00045
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Date of Event
    October 16, 2025
    Report Date
    November 25, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740020088
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) OBSERVED A LARGE SPARK GENERATED FROM THE CELL-DYN EMERALD SERIAL NUMBER: (B)(6) WHEN THE PRINTER, BARCODE READER AND UPS WERE CONNECTED, AND THE INSTRUMENT WAS POWERED ON. THE UPS WAS FOUND TO HAVE WIRES THAT SHOULD HAVE BEEN FUSED TOGETHER THAT WERE NOT. THE INSTRUMENT WAS NOT FUNCTIONAL AFTER THE SPARK. THE FSR DETERMINED THE CELL-DYN EMERALD, SERIAL NUMBER: (B)(6), WAS THE CAUSE OF THE ISSUE AND CELL-DYN EMERALD, SERIAL NUMBER: (B)(6), WAS SUCCESSFULLY INSTALLED TO RESOLVE THE ISSUE. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL TICKETS ASSOCIATED WITH SPARK/SMOKE. THERE WERE NO ADDITIONAL SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS WITH REGARDS TO THE CURRENT ISSUE. THE CURRENT TICKET IS THE SOLE COMPLAINT RELATED TO SPARK/SMOKE FOR THE CELL-DYN EMERALD (09H39-01). THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO NON-CONFORMANCE'S OR POTENTIAL NON-CONFORMANCE'S WAS IDENTIFIED. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE CELL-DYN EMERALD, SERIAL NUMBER: (B)(6), WAS IDENTIFIED.

    Description of Event or Problem · 0

    DURING INSTALLATION OF THE CELL-DYN EMERALD THE ABBOTT FIELD SERVICE ENGINEER(FSE) CONNECTED THE PRINTER, UPS AND BARCODE READER. WHEN THEY THEN POWERED ON THE ANALYZER THEY OBSERVED A LARGE SPARK. THE UPS, CELL-DYN EMERALD AND PRINTER WERE NON-FUNCTIONAL AFTER THIS OCCURRED. NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

    Description of Event or Problem · 0

    DURING INSTALLATION OF THE CELL-DYN EMERALD THE ABBOTT FIELD SERVICE ENGINEER (FSE) CONNECTED THE PRINTER, UPS AND BARCODE READER. WHEN THEY THEN POWERED ON THE ANALYZER THEY OBSERVED A LARGE SPARK. THE UPS, CELL-DYN EMERALD AND PRINTER WERE NON-FUNCTIONAL AFTER THIS OCCURRED. NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278123 CELL-DYN EMERALD INSTRUMENT COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740020088

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown