BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD

    MDR report key: 3936201 · Received July 15, 2014

    Report

    Report Number
    2919069-2014-00039
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING AND INSTRUMENT SERVICE. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. REPLACING THE WORN OUT AND LOOSE PARTS (TUBING, SAMPLE PROBE, AND O-RING), AND PERFORMING OVERDUE SERVICE PREVENTIVE MAINTENANCE RESOLVED THE ISSUE. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED PLATELET RESULTS FOR FOUR PATIENTS ON THE CELL-DYN EMERALD ANALYZER. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1 INITIAL 47, REPEAT 3 K/UL; PATIENT 2 INITIAL 39, REPEAT 2 K/UL; PATIENT 5 (SID (B)(6)) INITIAL 33, REPEAT 10 K/UL; PATIENT 6 INITIAL 29, REPEAT 3 K/UL; THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411846 CELL-DYN EMERALD AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1