BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD SYSTEM

    MDR report key: 19262461 · Received May 7, 2024

    Report

    Report Number
    2919069-2024-00029
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Date of Event
    April 16, 2024
    Report Date
    July 29, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTS THAT INSTRUMENT CELL-DYN EMERALD, LIST 09H39-01, SERIAL NUMBER (B)(6), FALSELY ELEVATED RESULTS FOR HGB, AS COMPARED TO A DIFFERENT INSTRUMENT AT A DIFFERENT LOCATION. INSTRUMENT PERFORMANCE, PRECISION AND PATIENT HISTORY SHOW NO DISCREPANCIES. THE INSTRUMENT HISTORY REVIEW REVEALED NO ADDITIONAL TICKETS RELATED TO THE COMPLAINT. A REVIEW OF TICKET TRENDING DID NOT IDENTIFY ANY RELATED TRENDS. REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY 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 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED HEMOGLOBIN RESULT GENERATED ON THE CELL DYN EMERALD INSTRUMENT FOR ONE PATIENT. (B)(6) 2024 INITIAL HEMOGLOBIN RESULTED IN 23.6. RERUN AT MAIN HOSPITAL RESULTED AT 11.9. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED HEMOGLOBIN RESULT GENERATED ON THE CELL DYN EMERALD INSTRUMENT FOR ONE PATIENT. (B)(6)2024 INITIAL HEMOGLOBIN RESULTED IN 23.6. RERUN AT MAIN HOSPITAL RESULTED AT 11.9. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439678 CELL-DYN EMERALD SYSTEM COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown