BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD 22 INSTRUMENT

    MDR report key: 23085694 · Received September 18, 2025

    Report

    Report Number
    2919069-2025-00042
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    August 31, 2025
    Report Date
    October 8, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    PMA / PMN Number
    K110381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION E1 - PHONE NUMBER COMPLETE ENTRY = (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    UPDATE: SECTION H4 - DEVICE MFG DATE UPDATED FROM BLANK TO 2/7/2022. THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT, PERFORMED TROUBLESHOOTING, AND REPLACED THE E22 IHM BOARD. THEY WERE UNABLE TO DUPLICATE THE SPARK THAT THE CUSTOMER OBSERVED. NO ADDITIONAL INSTANCES OF SPARKING HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY OCCURRED. THE INSTRUMENT SERVICE HISTORY REVIEW FOR CD EMERALD 22 OPEN TUBE, SERIAL NUMBER (B)(6), REVEALED NO ADDITIONAL SERVICE TICKETS ASSOCIATED WITH THE CURRENT COMPLAINT. A REVIEW OF TRACKING AND TRENDING FOR THE CD EMERALD 22 OPEN TUBE DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NON-CONFORMANCES OR POTENTIAL NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE CD EMERALD 22 OPEN TUBE FOR SERIAL (B)(6), WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A WHITE SCREEN AND HUMMING NOISE ON THE CELL-DYN EMERALD. THE CUSTOMER STATES THE INSTRUMENT SHUTS DOWN AND POWERS OFF FOR NO REASON. IT IS THEN DIFFICULT TO START BACK UP. THE INSTRUMENT WAS UNPLUGGED, AND WHEN PLUGGING IT BACK IN, A SPARK WAS OBSERVED FROM THE INSTRUMENT PLUG AND POWER OUTLET. THERE WAS NO DAMAGE REPORTED. NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A WHITE SCREEN AND HUMMING NOISE ON THE CELL-DYN EMERALD. THE CUSTOMER STATES THE INSTRUMENT SHUTS DOWN AND POWERS OFF FOR NO REASON. IT IS THEN DIFFICULT TO START BACK UP. THE INSTRUMENT WAS UNPLUGGED, AND WHEN PLUGGING IT BACK IN, A SPARK WAS OBSERVED FROM THE INSTRUMENT PLUG AND POWER OUTLET. THERE WAS NO DAMAGE REPORTED. NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2835642 CELL-DYN EMERALD 22 INSTRUMENT COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown