BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELL-DYN EMERALD

    MDR report key: 4248462 · Received November 13, 2014

    Report

    Report Number
    2919069-2014-00072
    Event Type
    Injury
    Date Received
    November 13, 2014
    Report Date
    October 29, 2014
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K081495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: FURTHER EVALUATION OF THE CUSTOMER ISSUE INCLUDED. A REVIEW OF THE COMPLAINT TEXT, ABBOTT FIELD SERVICE REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF PRODUCT LABELING. EVIDENCE INDICATES THAT SAMPLE HANDLING/PREANALYTICS MAY HAVE BEEN A FACTOR IN GENERATING THE DECREASED RESULTS. AN ABBOTT FIELD SERVICE ENGINEER (FSE) COMPLETED TROUBLESHOOTING OF THE INSTRUMENT. THIS INVOLVED COMPLETING A SYSTEM CLEAN AND RESETTING TUBING THAT WAS IDENTIFIED AS LOOSE AND CALIBRATING THE INSTRUMENT. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION A PRODUCT DEFICIENCY OF THE CELL-DYN EMERALD ANALYZER, LIST NUMBER 09H39 WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED AN UNNECESSARY BONE MARROW PROCEDURE WAS PERFORMED DUE TO GENERATING FALSELY DECREASED HEMOGLOBIN, WHITE BLOOD CELL AND PLATELET RESULTS WHILE USING THE CELL-DYN EMERALD ANALYZER. NO SPECIFIC DATA HAS BEEN PROVIDED REGARDING THE PROCEDURE OR RESULTS FOR THE PATIENT. IT WAS INDICATED THAT THE PATIENT RECOVERED WITHOUT ANY ADVERSE IMPACT DUE TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733631 CELL-DYN EMERALD AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other HEMOGLOBIN