BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD

    MDR report key: 7588181 · Received June 11, 2018

    Report

    Report Number
    2919069-2018-00031
    Event Type
    Malfunction
    Date Received
    June 11, 2018
    Date of Event
    May 22, 2018
    Report Date
    June 28, 2018
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    UDI-DI
    00380740020088
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER STATED THE PROBE GETS STUCK WHEN RUNNING QC, SO THE CUSTOMER REMOVED THE PROBE AND RINSE HEAD, FLUSHED THEM, AND THEN RAN A BLEACH START UP WITHOUT RESOLUTION. DURING THE SUBSEQUENT FIELD SERVICE ENGINEER VISIT, THE FSE FOUND THE DILUENT CUBE TUBING WAS PINCHED BY THE PRINTER NEXT TO IT AND ALSO FOUND GREASE ON THE PROBE. THE FSE CLEANED THE PROBE, MOVED THE PRINTER, AND RAN CONTROLS, WHICH RECOVERED WITHIN SPECIFICATION. A REVIEW OF LABELING SUGGESTS TROUBLESHOOTING FOR IMPRECISE OR INACCURATE, RBC, PLT AND HCT RESULTS, BUT THERE IS NO INSTRUCTION IN THE OPERATOR'S MANUAL REGARDING RINSE HEAD REMOVAL, THIS IS A FIELD SERVICE RESPONSIBILITY. A REVIEW OF TICKETS FOUND NO ADDITIONAL SIMILAR TICKETS FOR THE CELL DYN EMERALD AND NO TRENDS WERE IDENTIFIED. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE CELL-DYN EMERALD, SERIAL NUMBER (B)(6).

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE IS NO FURTHER PATIENT INFORMATION PROVIDED DUE TO PRIVACY ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED PLATELET RESULTS ON TWO PATIENTS GENERATED ON THE CELL DYN EMERALD ANALYZER. THE RESULTS PROVIDED WERE: S1 = 1066 / REPEATED = 1013; REFERENCE LAB = 128 (RANGE =133-450); S2 = 24 / 61 / 1208 / REFERENCE LAB = 166 (RANGE = 133-450). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430248 CELL-DYN EMERALD AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION 00380740020088

    Patients

    Seq Age Sex Outcome Treatment
    1