BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD SYSTEM

    MDR report key: 12856216 · Received November 22, 2021

    Report

    Report Number
    2919069-2021-00024
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Date of Event
    November 1, 2021
    Report Date
    March 2, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740020088
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED VARIOUS MAINTENANCE ACTIVITIES AND VERIFIED THAT THE INSTRUMENT PASSED PRECISION TWICE USING CONTROLS. HOWEVER, PRECISION FAILED ON RBC AND PLT WHEN USING A FRESH PATIENT SAMPLE. THE FSE REPLACED THE SYRINGE BODY AND SEAL PLATE AND PERFORMED FLUSHING AND BACKWASH. AFTER THE SERVICE, PRECISION WITH THE BLOOD PASSED. QUALITY CONTROL (QC) WAS PERFORMED, AND ALL RESULTS WERE WITHIN RANGE. THE CELL DYN EMERALD ANALYZER WAS OPERATING PROPERLY FOR A WHILE, BUT THE ISSUE RETURNED. THE CELL DYN EMERALD ANALYZER GENERATED PLT RESULTS THAT WERE DIFFERENT COMPARED TO THE OTHER INSTRUMENTS. THE INSTRUMENT MAINTENANCE RECORD (EVENT LOG) WAS NOT AVAILABLE FOR A REVIEW. PER CUSTOMER¿S REQUEST, THE INSTRUMENT WAS REMOVED FROM THE SITE AND NO FURTHER INVESTIGATION COULD BE PERFORMED. A REVIEW OF TRACKING AND TRENDING OF THE CELL DYN EMERALD DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE CELL DYN EMERALD FOR SERIAL 5793 WAS IDENTIFIED. SECTION G1 HAS BEEN UPDATED TO CURRENT CONTACT INFORMATION.

    Additional Manufacturer Narrative · 0

    (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED PLATELET RESULTS GENERATED ON THE CELL-DYN EMERALD WHEN COMPARED TO ANOTHER METHOD. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): PLATELET: EMERALD =142, REPEAT = 100, ADVIA = 3. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED PLATELET RESULTS GENERATED ON THE CELL-DYN EMERALD FOR ONE SAMPLE WHEN COMPARED TO ANOTHER METHOD. THE FOLLOWING DATA WAS PROVIDED: (B)(6) EMERALD RESULT =142, REPEAT = 100, ADVIA RESULT = 3. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1751653 CELL-DYN EMERALD SYSTEM COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 09H39-01 00380740020088

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown