BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD

    MDR report key: 2961216 · Received February 14, 2013

    Report

    Report Number
    2919069-2013-00006
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT EVALUATION WAS PERFORMED IN ORDER TO INVESTIGATE FALSELY ELEVATED HEMOGLOBIN RESULTS. A REVIEW OF SERVICE HISTORY FOR THE CELL-DYN EMERALD, SERIAL NUMBER (B)(4), WAS CONDUCTED AND FOUND NO ISSUES. A REVIEW OF THE CELL-DYN EMERALD SYSTEM OPERATOR'S MANUAL (9213300G, AUGUST 2012) WAS PERFORMED AND FOUND ADEQUATE INSTRUCTIONS FOR TROUBLESHOOTING WHEN IMPRECISE HGB RESULTS ARE OBSERVED. A REVIEW OF HISTORICAL COMPLAINT DATA DID NOT IDENTIFY A SIMILAR ISSUE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY AND NO MALFUNCTION OF THE CELL-DYN EMERALD ANALYZER, SERIAL NUMBER (B)(4) WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CELL-DYN EMERALD GENERATED A FALSELY ELEVATED HEMOGLOBIN (HGB) RESULT OF 23.3G/DL ON ONE PATIENT. RESULTS WERE QUESTIONED BY THE PHYSICIAN SO THE SAMPLE WAS RETESTED AND THE HGB RESULT GENERATED WAS 16.2G/DL. RESULTS PROVIDED BY CUSTOMER: INITIAL/REPEAT REF RANGE; RBC= 7.05/5.31 (4.0-5.8) M/UL, HGB= 23.3/16.2 (12-16) G/DL, HCT= 67.6/49.6 (37.7-47.9) %. THE CONTROLS WERE ALL WITHIN RANGE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65543 CELL-DYN EMERALD GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1