BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD

    MDR report key: 2508104 · Received March 28, 2012

    Report

    Report Number
    2919069-2012-00029
    Event Type
    Malfunction
    Date Received
    March 28, 2012
    Date of Event
    March 6, 2012
    Report Date
    March 13, 2012
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4); NO CONSEQUENCES OR IMPACT TO (B)(4); LOW TEST RESULTS AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. AN EVALUATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REQUESTED FIELD SERVICE FOR ISSUE RESOLUTION. THE ISSUE WAS RESOLVED AFTER FIELD SERVICE REPLACED THE COUNTING CHAMBERS (WITHOUT APERTURE). A REVIEW OF THE DATA SUBMITTED BY THE CUSTOMER SHOWED THAT THE RESULT CONTAINED DISPERSIONAL DATA ALERTS (L FLAG) FOR THE RBC, HGB, AND HCT PARAMETERS. THE CELL-DYN EMERALD OPERATOR'S MANUAL STATES THAT THIS FLAG IS GENERATED WHEN A RESULT FALLS BELOW THE LOWER PANIC LIMITS SET BY THE LABORATORY. WHEN A RESULT IS FLAGGED WITH A PATIENT OR PANIC LIMITS ALERT, IT IS RECOMMENDED THAT THE CUSTOMER FOLLOW HIS/HER LABORATORY'S REVIEW CRITERIA, WHICH MAY INCLUDE REVIEW OF A STAINED SMEAR TO VERIFY THE RESULT AND TO CHECK FOR THE PRESENCE OF ANY ADDITIONAL ABNORMALITY. BASED ON THE EVENT DETAILS AND INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED WITH THE CELL-DYN EMERALD INSTRUMENT. THE ISSUE WAS RESOLVED AFTER REPLACING THE COUNTING CHAMBERS (WITHOUT APERTURE) ON THE INSTRUMENT. IN ADDITION, THE DATA SUBMITTED SHOWED THAT THE INSTRUMENT ALERTED THE OPERATOR TO A POTENTIALLY ERRONEOUS RESULT, WHICH REQUIRED FURTHER VERIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER STATED FALSELY DECREASED HEMOGLOBIN RESULTS WERE GENERATED ON THE CELL-DYN EMERALD. A PATIENT GENERATED A LOW HEMOGLOBIN RESULT OF 7.3 G/DL ON THE CELL-DYN EMERALD. THE PATIENT WAS SENT TO THE HOSPITAL WHERE A NEW SAMPLE WAS OBTAINED AND YIELDED A HEMOGLOBIN RESULT OF 10.2 G/DL (METHOD UNKNOWN). A RESULT OF 10.7 G/DL WAS GENERATED ON THE CELL-DYN 1800 AT ANOTHER SITE BUT IT IS NOT KNOWN IF THIS WAS THE ORIGINAL SAMPLE OR REDRAW. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN EMERALD GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1