BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD

    MDR report key: 5409998 · Received February 4, 2016

    Report

    Report Number
    2919069-2016-00005
    Event Type
    Malfunction
    Date Received
    February 4, 2016
    Date of Event
    January 18, 2016
    Report Date
    February 4, 2016
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION WAS PERFORMED BY REVIEWING THE COMPLAINT TEXT, OTHER CUSTOMER COMPLAINTS FOR SIMILAR ISSUES, REVIEW OF LABELING, AND REVIEW OF HISTORICAL DATA. THE CUSTOMER STATED THAT THE CELL-DYN EMERALD ANALYZER, SERIAL NUMBER (B)(4), GENERATED DISCREPANT PLT RESULTS ON ONE PATIENT SAMPLE. THE RESULT DATA WITH HISTOGRAMS (SEQ. 00027 AND SEQ. 00028) FOR THE SAMPLE STATED IN THE COMPLAINT WERE NOT SUBMITTED. THIS INVESTIGATION USED THE SUBMITTED DATA FOR ONE PATIENT SAMPLE TO ILLUSTRATE THE ISSUE FOUND, SEQ. 00032 AND SEQ. 00033, DATED 01/28/2016. THE RESULT FOR SEQ. 00032 WAS A PLT OF 1245 10E3/UL. THE PLT RESULT WAS FLAGGED INVALID BY AN ASTERISK. IN SEQ. 00032, THE PLT HISTOGRAM SHOWED THE CELL POPULATION WAS NOT DETECTED AND THE HISTOGRAM WAS ABNORMALLY SHORT. THE PLT SIZE DETECTION ISSUE WAS REFLECTED ON THE ABNORMALLY LOW MPV OF 3.9*FL. SEQ. 00033 MPV 7.4 FL WAS TWICE THE VALUE OF THE INITIAL RUN AND THE LARGER HISTOGRAM SHOWED DETECTION OF THE PLT. THE PLT RESULT OF 111 10E3/UL, ALTHOUGH FLAGGED "L" WAS A VALID RESULT. A CLOGGED / OBSTRUCTED COUNTING CHAMBER COULD AFFECT PLT SIZE DETECTION. FIELD SERVICE REPLACED THE COUNTING CHAMBER W/O APERTURE DURING THE SERVICE VISIT RELATED TO THE DISCREPANT PLT ISSUES. THERE WERE NO TRENDS / SIMILAR COMPLAINTS IDENTIFIED DURING THE HISTORICAL COMPLAINT REVIEW WITH RESPECT TO THE COUNTING CHAMBER W/O APERTURE OR FOR THE CELL-DYN EMERALD PLATFORM. A REVIEW OF THE CELL-DYN EMERALD OPERATOR'S MANUAL PROVIDES ADDITIONAL INFORMATION RELATED TO DATA-RELATED PROBLEMS. BASED ON THE INVESTIGATION A PRODUCT ISSUE RELATED TO THIS INSTRUMENT-SPECIFIC INCIDENT WAS NOT IDENTIFIED FOR THE CELL-DYN EMERALD PLATFORM OR THE COUNTING CHAMBER W/O APERTURE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE CELL-DYN EMERALD ANALYZER GENERATED DISCREPANT PLATELET (PLT) RESULTS ON ONE PATIENT. THE INITIAL PLT RESULT WAS "----" / REPEATED 1462 / 178. THE CUSTOMER STATED THE 178 IS CONSISTENT WITH THE PATIENT'S HISTORICAL RESULTS. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68587 CELL-DYN EMERALD AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1