BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD SYSTEM

    MDR report key: 17606990 · Received August 23, 2023

    Report

    Report Number
    2919069-2023-00027
    Event Type
    Malfunction
    Date Received
    August 23, 2023
    Date of Event
    August 3, 2023
    Report Date
    November 6, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740020088
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION SECTION H4 - DEVICE MFG DATE UPDATED FROM BLANK TO 6/23/2021 SECTION D10 - CONCOMITANT PRODUCT UPDATED FROM BLANK TO COUNTING CHAMBERS W/O APERTURE, 8701685903, UNKNOWN. THE COMPLAINT INVESTIGATION FOR DISCREPANT RED BLOOD CELL (RBC) COUNT RESULTS GENERATED ON THE CELL-DYN EMERALD INCLUDED A REVIEW OF DATA AND INFORMATION INITIALLY PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND REPLACED THE COUNTING CHAMBERS W/O APERTURE PART. REPLACEMENT OF THE PART RESOLVED THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THERE WERE NO SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. AN INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS REPORTED FOR THE CELL-DYN EMERALD ANALYZER. A REVIEW OF TRACKING AND TRENDING OF THE CELL-DYN EMERALD DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE CELL-DYN EMERALD FOR SERIAL 10176, OR THE COUNTING CHAMBERS W/O APERTURE WAS IDENTIFIED. SECTION G1 WITH CORRECTED/UPDATED INFORMATION.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A1 - PATIENT IDENTIFIER COMPLETE ENTRY = (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED DISCREPANT HEMOGLOBIN (HGB) RESULTS GENERATED ON THE CELL-DYN EMERALD FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2023 SAMPLE ID (B)(6) INITIAL HGB RUN AT LABCORP = 7.9 G/DL (REFERENCE RANGE 11.1-15.9 G/DL), REPEAT ON EMERALD = 9.2 G/DL (REFERENCE RANGE 12.0-15.5 G/DL) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED DISCREPANT HEMOGLOBIN (HGB) RESULTS GENERATED ON THE CELL-DYN EMERALD FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2023 SAMPLE ID (B)(6) INITIAL HGB RUN AT LABCORP = 7.9 G/DL (REFERENCE RANGE 11.1-15.9 G/DL), REPEAT ON EMERALD = 9.2 G/DL (REFERENCE RANGE 12.0-15.5 G/DL) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1812405 CELL-DYN EMERALD SYSTEM COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740020088

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown COUNTING CHAMBERS W/O APERTURE, 8701685903, UNKNOW