BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD SYSTEM

    MDR report key: 11447083 · Received March 9, 2021

    Report

    Report Number
    2919069-2021-00008
    Event Type
    Malfunction
    Date Received
    March 9, 2021
    Report Date
    June 22, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740020088
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    COMPONENT CODE: G03001. ABBOTT FIELD SERVICE (FS) WAS REQUESTED FOR SOME MAINTENANCE AFTER THE ISSUE. THERE WERE NO ADDITIONAL DISCREPANT RESULTS REPORTED ON THE CELL-DYN EMERALD, SERIAL NUMBER (B)(6), AFTER THE SERVICE. A PATIENT SAMPLE WAS NOT REPEATED ON CELL-DYN EMERALD AND WAS SENT TO ANOTHER LAB AND TESTED 3 HOURS LATER ON AN UNKNOWN ANALYZER. THIS UNKNOWN INSTRUMENT WAS A 5-PART DIFFERENTIAL ANALYZER WHICH WAS DIFFERENT FROM THE 3-PART DIFFERENTIAL INSTRUMENT LIKE CELL-DYN EMERALD. RESULTS GENERATED BY THE UNKNOWN ANALYZER WERE LOWER FOR WBC, RBC, HGB, MCV AND HCT, AND HIGHER FOR PLT. WBC DIFFERENTIAL ALSO DID NOT MATCH THE CELL-DYN EMERALD RESULTS, BUT DUE TO THE DIFFERENT TECHNOLOGIES, A DIRECT COMPARISON BETWEEN CELL-DYN EMERALD AND THIS ANALYZER COULD NOT BE MADE. THE MANUAL READING ON WBC DIFFERENTIAL WAS ALSO NOT EXACTLY MATCHED TO EITHER CELL-DYN EMERALD OR THIS UNKNOWN ANALYZER. OVERALL, THE ACTUAL PATIENT RESULTS COULD NOT BE CONFIRMED FROM THE DATA PROVIDED IN THIS TICKET. THE BLOOD COLLECTION TUBE TYPE WAS UNKNOWN, BUT IT WAS LIKELY A CAPILLARY SAMPLE. IF THE SAMPLE VOLUME WAS VERY SMALL, AND/OR IF SAMPLE MIXING WAS HARDER DUE TO LOW SAMPLE VOLUME, THEN COUNT-TO-COUNT VARIATION MIGHT POTENTIALLY OCCUR. CELL-DYN EMERALD ONLY ALLOWED OPEN MODE TESTING, AND IT WAS UNKNOWN WHICH MODE (OPEN OR CLOSED IF IT COULD BE CHOSEN) WAS USED ON THE OTHER ANALYZER. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE CELL-DYN EMERALD ANALYZER SERIAL NUMBER (B)(6) WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP IS BEING SUBMITTED TO INCLUDE D8 AND H6 INFORMATION PREVIOUSLY SUBMITTED USING THE H10 SECTION IN THEIR RESPECTIVE FIELDS.

    Additional Manufacturer Narrative · 1

    (B)(4). WAS THIS DEVICE SERVICED BY A THIRD PARTY?: NO. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED DISCREPANT CBC (COMPLETE BLOOD COUNT) RESULTS FOR MULTIPLE PATIENTS AND CONTROLS OUT OF RANGE ON CELL-DYN EMERALD. THE ONE EXAMPLE PATIENT RESULTS PROVIDED: ON (B)(6) 2021, SID: (B)(6) HEMOGLOBIN=25.0 G/DL / REPEATED AT ANOTHER HOSPITAL=20.0 G/DL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339798 CELL-DYN EMERALD SYSTEM COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 09H39-01 00380740020088

    Patients

    Seq Age Sex Outcome Treatment
    1