BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD

    MDR report key: 4041422 · Received August 27, 2014

    Report

    Report Number
    2919069-2014-00054
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    August 1, 2014
    Report Date
    September 4, 2014
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION TEAM REVIEWED THE CUSTOMER ISSUE AND SUBMITTED DATA. SEVERAL OBSERVATIONS WERE MADE WHICH COULD NOT BE ELIMINATED AS CONTRIBUTING FACTORS FOR THE DIFFERENCE IN PLATELET RESULTS BETWEEN THE CELL-DYN EMERALD AND THE NON-ABBOTT ANALYZER. THE CELL-DYN EMERALD PLATELET TEST RESULTS WERE TAKEN FROM PATIENTS WITH KNOWN PATHOLOGICAL DISEASES SUCH AS ACUTE MYELOID LEUKEMIA WHICH HAVE INTERFERING SUBSTANCES AND CONDITIONS. NO CALIBRATION CORRELATION STUDIES WERE PERFORMED BETWEEN THE CELL-DYN EMERALD AND THE NON-ABBOTT INSTRUMENTS. BASED ON THE CUSTOMER INFORMATION, THE TRUE PLATELET VALUES FOR THESE PATIENTS WERE UNKNOWN. THE DIFFERENCES IN INSTRUMENT CALIBRATION AFFECTING PLATELET RESULTS CANNOT BE ELIMINATED. THE ADVIA ANALYZER HAS DIFFERENT TECHNOLOGIES AND REAGENTS THAN THE CELL-DYN EMERALD ANALYZER. THE DIFFERENCES IN TECHNOLOGY, REAGENTS AND MAINTENANCE AFFECTING THE DIFFERENCES IN PLATELET RESULTS CANNOT BE ELIMINATED. REVIEW OF SUBMITTED DATA INDICATED RESULTS FOR OTHER MAJOR PARAMETERS EXCEPT PLATELET, CORRELATED BETWEEN CELL-DYN EMERALD AND ADVIA INSTRUMENT. THE CELL-DYN EMERALD RBC COUNTING HEAD, WAS CLEANED, LUBRICATED, AND REINSTALLED AS PART OF TROUBLESHOOTING. PER THE CUSTOMER COMPLAINT TEXT, QUALITY CONTROL, BACKGROUND AND PRECISION ARE ALL WITHIN SPECIFICATION. THIS SUGGESTED THAT THE CELL-DYN EMERALD, WAS PERFORMING AS DESIGNED. THE CELL-DYN EMERALD SYSTEM OPERATOR'S MANUAL, UNDER SUBSECTION, INTERFERING SUBSTANCES AND CONDITIONS, PROVIDES ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. BASED ON THE INVESTIGATION WHICH INCLUDED REVIEW OF PRODUCT HISTORICAL DATA AND PRODUCT LABELING, IT WAS CONCLUDED THAT THE COMPLAINT ISSUE WERE SAMPLE SPECIFIC INVOLVING PATHOLOGY SAMPLES WITH INTERFERING SUBSTANCES AND CONDITIONS WHICH AFFECTED SAMPLE PROCESSING. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED FOR THE CELL-DYN EMERALD SYSTEM.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED FALSELY ELEVATED PLATELET (PLT) RESULTS ON 3 PATIENTS PROCESSED ON THE CELL-DYN EMERALD. PATIENT 1 GENERATED CELL-DYN EMERALD PLT = 68 10^3/UL BUT REPEATED AT THE HOSPITAL LAB PLT = 6 K/MCL. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED FOR PATIENT 1. PATIENT 2 GENERATED CELL-DYN EMERALD PLT = 55 10^3/UL BUT REPEATED AT THE HOSPITAL LAB PLT=4 K/MCL. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED FOR PATIENT 2. PATIENT 3, ID 11003, HAD 3 SAMPLES. SAMPLE 1 ON (B)(6) 2014 GENERATED CELL-DYN EMERALD PLT = 42 10^3/UL BUT REPEATED AT THE HOSPITAL LAB=18 K/MCL. SAMPLE 2 ON (B)(6) 2014 GENERATED CELL-DYN EMERALD PLT = 37 10^3/UL BUT REPEATED AT THE HOSPITAL LAB=15 K/MCL. SAMPLE 3 ON (B)(6) 2014 GENERATED CELL-DYN EMERALD PLT = 55 10^3/UL BUT REPEATED AT THE HOSPITAL LAB=10 K/MCL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED FOR THE 3 PATIENTS.

    Description of Event or Problem · 1

    TWO ADDITIONAL PATIENTS GENERATED FALSELY ELEVATED CELL-DYN EMERALD PLATELET RESULTS COMPARED TO ANOTHER METHOD. (B)(6). PATIENT ID (B)(6), HAS ACUTE MYELOID LEUKEMIA. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED FOR ID (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519782 CELL-DYN EMERALD AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR