BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD

    MDR report key: 3125389 · Received May 22, 2013

    Report

    Report Number
    2919069-2013-00046
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    February 20, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION WAS PERFORMED IN ORDER TO INVESTIGATE THIS ISSUE. THE SYSMEX INSTRUMENT AND THE CD EMERALD HAVE FACTOR DIFFERENCES WHICH CAN AFFECT THEIR RESULTS, FOR EXAMPLES, DIFFERENT TECHNOLOGIES AND CALIBRATIONS OF EACH INSTRUMENT. THE INABILITY OF THE INSTRUMENT TO MEASURE A PARTICULAR MEASURE MAYBE DUE TO A SAMPLE ABNORMALITY. ANY SUBSTANCE OR CONDITION THAT CAN INTERFERE WITH THE CELL-DYN EMERALD SYSTEMS PRINCIPLES OF OPERATION SHOULD BE CONSIDERED AN INTERFERING SUBSTANCE OR CONDITION. BASED ON THE INVESTIGATION, THE CELL-DYN EMERALD ANALYZER WAS PERFORMING AS DESIGNED. THERE WAS NO PRODUCT DEFICIENCY, NO MALFUNCTION AND NO ACTION TAKEN FOR THE COMPLAINT ISSUE.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE CELL DYN EMERALD ANALYZER GENERATED HIGHER PLT RESULTS FROM PATIENT SAMPLES COMPARED TO LOWER RESULTS GENERATED AT A REFERENCE LAB. ONE PATIENT SAMPLE (SID (B)(4)) GENERATED A RESULT OF 39 K/UL ON THE CELL-DYN ANALYZER COMPARED TO A RESULT OF 10 GENERATED AT THE REFERENCE LAB. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE CELL DYN EMERALD ANALYZER GENERATED HIGHER PLT RESULTS FROM PATIENT SAMPLES COMPARED TO LOWER RESULTS GENERATED AT A REFERENCE LAB (QUEST). ONE PATIENT SAMPLE GENERATED A RESULT OF 39 K/UL ON THE CELL-DYN ANALYZER COMPARED TO A RESULT OF 9 K/UL GENERATED AT THE REFERENCE LAB. THE SAME PATIENT WAS DRAWN ON (B)(6) 2013 WITH A RESULT OF 25 K/UL ON THE CELL-DYN EMERALD AND A RESULT OF 11 AT THE REFERENCE LAB. THE PATIENT HAS BEEN QUESTIONING THE RESULTS GENERATED WITH THE EMERALD. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227004 CELL-DYN EMERALD GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1