BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELL-DYN 3500 CS ANALYZER

    MDR report key: 1611541 · Received February 22, 2010

    Report

    Report Number
    2919069-2010-00043
    Event Type
    Injury
    Date Received
    February 22, 2010
    Date of Event
    January 29, 2010
    Report Date
    January 29, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K955715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) THE PRODUCT CONTAINS ADEQUATE LABELING FOR PROPER PERSONAL PROTECTIVE EQUIPMENT FOR POTENTIAL EXPOSURE TO HAZARDS, AND RECOMMENDS THE OPERATOR TO WEAR POWDER-FREE GLOVES, LABCOAT AND SAFETY GLASSES WHEN MAINTAINING OR REPAIRING THE INSTRUMENT. A NON-STATISTICAL TREND (NST) REVIEW WAS PERFORMED USING COMPLAINT DOCUMENTATION AND NO NST WAS IDENTIFIED. AS PART OF THE INVESTIGATION, THE CUSTOMER WAS REFERRED TO THE PRODUCT LABELING REGARDING PREVENTION OF EXPOSURE TO CHEMICALS USED IN THE OPERATION AND MAINTENANCE OF THE CELL-DYN 3500 SYSTEM BY USING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT. BASED ON THE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED FOR THE CELL-DYN 3500 RELATED TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE NIGHT SHIFT OPERATOR GOT A DROP OF ENZYMATIC CLEANER ON HER EYELID WHEN PERFORMING MAINTENANCE ON A CELL-DYN 3500 CS ANALYZER. THE OPERATOR WAS OPENING A BOTTLE OF ENZYMATIC CLEANER CONCENTRATE WHEN A SMALL DROPLET SPLASHED ONTO HER EYELID. SHE RINSED HER EYELID OFF, BUT IN THE AFTERNOON NOTICED THAT HER EYELID HAD SWOLLEN. THE MATERIAL DATA SAFETY SHEET (MSDS) SHEET FOR ENZYMATIC CLEANER WAS FAXED TO THE CUSTOMER AND BROUGHT TO THE EMERGENCY WARD TO HELP THE OPERATOR GET PROPER TREATMENT. THE OPERATOR WAS SEEN BY AN EMERGENCY ROOM PHYSICIAN THAT PRESCRIBED A CREAM (NAME NOT PROVIDED) FOR TREATMENT OF THE INJURY TO HER EYELID. THERE WAS NO REPORT OF IMPAIRMENT OF VISION RELATED TO THIS EVENT. THE OPERATOR WAS NOT WEARING PROTECTIVE EYEWEAR AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 3500 CS ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R ENZYMATIC CLEANER LN 99644-01 LOT # UNK