BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELL-DYN EMERALD

    MDR report key: 7029163 · Received November 14, 2017

    Report

    Report Number
    2919069-2017-00156
    Event Type
    Injury
    Date Received
    November 14, 2017
    Date of Event
    October 25, 2017
    Report Date
    December 21, 2017
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    UDI-DI
    00380740020088
    PMA / PMN Number
    K081495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WAS PERFORMED FOR THE BLEACH EXPOSURE CAUSING AN ASTHMA ATTACK. THE PARTS, ELECTROVALVE 2-2, AND OPTICAL PROBE SENSOR, WERE REPLACED BY FIELD SERVICE TO RESOLVE THE CUSTOMER'S REPORTED ISSUE AND WHY SERVICE WAS AT THE SITE. A REVIEW OF PRODUCT HISTORICAL DATA DID NOT IDENTIFY ANY TRENDS OR ADDITIONAL CUSTOMER COMPLAINTS FOR THIS ISSUE. A REVIEW OF THE CELL-DYN EMERALD OPERATOR'S MANUAL PROVIDES ADEQUATE INFORMATION TO ADDRESS THIS INCIDENT. PER THE INFORMATION WITHIN THE COMPLAINT RECORD, THE DEVICE MET PERFORMANCE SPECIFICATIONS AND PERFORMED AS INTENDED AT THE CUSTOMER SITE. BASED ON THIS INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE CELL-DYN EMERALD, LIST NUMBER 09H39-01, SERIAL NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    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 REPORTED THAT WHEN THE FIELD SERVICE ENGINEER PERFORMED A BLEACH MAINTENANCE ON THE CELL DYN EMERALD SHE WAS PRESENT AND SUFFERED AN ASTHMA ATTACK. THE CUSTOMER SUFFERS FROM ASTHMA AND HAS AN ALLERGY TO BLEACH. DUE TO THE EXPOSURE TO THE BLEACH FUMES SHE HAD TO TAKE AN EMERGENCY ASTHMA TREATMENT /MEDICATION (DOUNAB INHALER, ALLAVERT, PREDOZONE, AND SINGULAIR). THE TREATMENT WAS SUCCESSFUL IN HALTING THE ASTHMA ATTACK AND NO FURTHER TREATMENT WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807849 CELL-DYN EMERALD AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION 00380740020088

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention