BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD

    MDR report key: 3901787 · Received June 30, 2014

    Report

    Report Number
    2919069-2014-00035
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    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. AN ABBOTT FIELD SERVICE ENGINEER (FSE) COMPLETED TROUBLESHOOTING OF THE INSTRUMENT. THIS INVOLVED A PART REPLACEMENT PER NORMAL TROUBLESHOOTING PROCEDURES, WHICH RESOLVED THE ISSUE. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF CELL-DYN EMERALD ANALYZER, LIST NUMBER (B)(4) WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER GENERATED ERRATIC PLATELET RESULTS FOR MULTIPLE PATIENTS WHILE USING THE CELL-DYN EMERALD ANALYZER. THE CUSTOMER INDICATED THEY OBTAINED RESULTS WHICH WERE EITHER A RESULT OF ZERO (WHICH WAS FLAGGED) OR THEY GENERATED ELEVATED PLATELET COUNTS OF 600-700. THE REFERENCE RANGE PROVIDED IS 142-424. A SPECIFIC NUMBER OF PATIENTS WAS NOT INDICATED. ON (B)(6) 2014, ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER INDICATING APPROXIMATELY SIX PATIENT SAMPLES GENERATED EITHER NO RESULT OR A VERY HIGH PLATELET RESULT EACH BETWEEN 1300-1400. THE MANUAL COUNTS WERE DEEMED WITHIN NORMAL RANGE. THE CELL-DYN EMERALD DID GENERATE A FLAG TO INDICATE A HIGH RESULT WAS GENERATED. NO INCORRECT RESULTS WERE REPORTED FROM THE LABORATORY. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THE CUSTOMER HAS INDICATED THEY WILL NOT PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380702 CELL-DYN EMERALD AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1