BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELL-DYN EMERALD

    MDR report key: 3021516 · Received March 26, 2013

    Report

    Report Number
    2919069-2013-00033
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K081495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    REVIEW OF PRIOR SERVICE ACTIVITY FOR THE CUSTOMER'S CELL-DYN EMERALD INSTRUMENT IN 2013 INDICATED THAT THERE WERE TWO ADDITIONAL SERVICE TICKETS INITIATED. ONE TICKET WAS RELATED TO THE AUTO CLEAN CHECK BOX BEING DESELECTED FOLLOWING CALIBRATION. THIS ISSUE DOES NOT INHIBIT THE OPERATION OF THE INSTRUMENT AND IS NOT RELATED TO THIS EVENT. THE OTHER TICKET WAS INITIATED FOR A PROBE LEAK ISSUE. IS LIKELY RELATED TO THIS COMPLAINT. CUSTOMER SERVICE HAD INSTRUCTED THE CUSTOMER NOT TO RUN QC IF THE PROBE WAS LEAKING, AS IT MAY DILUTE THE QC MATERIAL, AND FIELD SERVICE WAS DISPATCHED TO ASSESS THE ISSUE. A BLOOD CLOT FROM THE RINSE WASTE TUBING WAS REMOVED, WHICH RESOLVED THE ISSUE. THIS TYPE OF OBSTRUCTION IS DUE TO PATIENT SAMPLE. ELECTRONIC VALVES, EV-3, 4, 5 AND 6 WERE ALSO REPLACED AS A PRECAUTIONARY MEASURE. AT THE TIME THIS COMPLAINT WAS RECEIVED, THE LABORATORY REPORTED THAT THE INSTRUMENT WAS OPERATIONAL, AND THERE WERE NO ISSUES BEING OBSERVED. THERE IS NO SERVICE HISTORY INDICATING THAT THERE IS A CHRONIC PROBLEM WITH THIS INSTRUMENT. BASED ON THE EVENT DETAILS AND INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED WITH THE CELL-DYN EMERALD INSTRUMENT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT CHEMOTHERAPY FOR FIVE PATIENTS ON TWO DIFFERENT DAYS (TOTAL OF 10 DIFFERENT PATIENTS) HAD TO BE RESCHEDULED BECAUSE THE CELL-DYN EMERALD ANALYZER WAS DOWN AND PATIENT RESULTS COULD NOT BE GENERATED. THE CUSTOMER HAD TO SEND THE SAMPLES TO ANOTHER LABORATORY FOR TESTING. THE LENGTH OF TIME THAT CHEMOTHERAPY WAS DELAYED IS UNKNOWN. NO SPECIFIC INDIVIDUAL PATIENT DATA WAS PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123131 CELL-DYN EMERALD GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other