BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD

    MDR report key: 2694356 · Received August 13, 2012

    Report

    Report Number
    2919069-2012-00056
    Event Type
    Malfunction
    Date Received
    August 13, 2012
    Date of Event
    August 7, 2012
    Report Date
    August 8, 2012
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) REPLACED THE RBC COUNT HEAD ON THE CUSTOMER'S CELL-DYN EMERALD ANALYZER TO RESOLVE THE REPORTED ISSUE (THE COUNT HEAD WAS FOUND TO BE WORN FROM NORMAL USE). THE FSR BLEACHED CLEANED AND FLUSHED THE LINES, AND CHECKED THE AUTOCLEAN BOX. THE INSTRUMENT WAS PERFORMING WITHIN LABELING SPECIFICATIONS AND SUBSEQUENT INSTRUMENT OPERATIONS WERE ACCEPTABLE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE CELL-DYN EMERALD SYSTEM OPERATOR MANUAL, LIST NUMBER 09H40-01,REVISION E, CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. BASED ON THE CURRENT EVALUATION AND INFORMATION RECEIVED, NO PRODUCT MALFUNCTION WAS IDENTIFIED WITH THE CELL-DYN EMERALD INSTRUMENT.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS ELEVATED PLATELET RESULTS FOR ONE PATIENT SAMPLE GENERATED ON A CELL-DYN EMERALD ANALYZER. AN INITIAL RESULT OF 1217 K/UL RETESTED AT 367 K/UL. THE SAMPLE WAS THEN TESTED ON ANOTHER CELL-DYN EMERALD ANALYSER IN THE LAB AND GENERATED A PLATELET RESULT OF 280 K/UL. CONTROLS HAVE REMAINED WITHIN SPECIFICATIONS. THE CUSTOMER WOULD NOT PROVIDE ANY FURTHER INFORMATION OTHER THAN TO VERIFY THAT THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED. THE CUSTOMER REQUESTED A SERVICE CALL TO RESOLVE.

    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 CD EMERALD LYSE: LN: 09H47-02 LOT:5212| CD EMERALD DILUENT: LN: 09H48-02 LOT: 5291| CD EMERALD CLEANER: LN: 09H46-02 LOT:5294| CD EMERALD DILUENT: LN: 09H48-02 LOT: 5291| CD EMERALD CLEANER: LN: 09H46-02 LOT:5294| RBC COUNTING HEAD: LN: 8701687701