BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 3700 CS ANALYZER

    MDR report key: 2032705 · Received March 29, 2011

    Report

    Report Number
    2919069-2011-00087
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K980614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CELL-DYN 3700 SYSTEM OPERATOR'S MANUAL, LIST NUMBER 06H89-01, REVISION F, UNDER CHAPTER 8: HAZARDS, SUBSECTION: HAZARD INFORMATION AND PRECAUTIONS, STATES THE FOLLOWING: WARNING: POTENTIAL BIOHAZARD. CONSIDER ALL CLINICAL SPECIMENS, REAGENTS, CONTROLS, SURFACES OR COMPONENTS THAT CONTAIN OR HAVE CONTACTED BLOOD, SERUM, OR OTHER BODILY FLUID AS POTENTIALLY INFECTIOUS. WEAR GLOVES, LAB COATS, AND SAFETY GLASSES, AND FOLLOW OTHER BIOSAFETY PRACTICES AS SPECIFIED IN THE OSHA BLOODBORNE PATHOGEN RULE (29CFR PART 1910.1030) OR OTHER EQUIVALENT BIOSAFETY PROCEDURES. CHAPTER 8: HAZARDS, SUBSECTION: PHYSICAL AND MECHANICAL HAZARDS STATES TO WEAR POWDER-FREE GLOVES, LABCOAT, AND SAFETY GLASSES WHEN MAINTAINING OR REPAIRING THE INSTRUMENT. THE RISK MANAGEMENT FILE FOR THE CELL-DYN 3700 INDICATES THAT THE USER MAY HAVE EXPOSURE TO INCIDENTS CLASSIFIED AS HAZARDOUS THROUGH CONTACT WITH BLEACH OR ENZYME CLEANER DURING INSTRUMENT MAINTENANCE. CONTROLS IN PLACE TO REDUCE THE RISK ARE PERSONAL PROTECTIVE EQUIPMENT, HANDLING INSTRUCTIONS, HAZARD CLASSIFICATIONS, MATERIAL SAFETY DATA SHEETS, AND INSTRUCTIONS IN MANUAL FOR HANDLING AND MAINTENANCE OF THE INSTRUMENT. THE OVERALL RISK LEVEL IS LOW. A NON-STATISTICAL TREND (NST) REVIEW WAS PERFORMED IN THE COMPLAINT ANALYSIS TRENDING SYSTEM FOR THE REPORTED ISSUE. NO NST WAS IDENTIFIED DURING THE SEARCHED PERIOD. BASED ON THE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED FOR THE CELL-DYN 3700 RELATED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THE OPERATOR SPLASHED 6% HYPOCHLORITE SOLUTION IN HER EYE. THE OPERATOR WAS TRYING TO CLEAN THE CELL-DYN 3700 FLOW CELL BECAUSE THE WOC RESULTS WERE LOW COMPARED TO THE WIC RESULTS. THE OPERATOR SPLASHED 6% HYPOCHLORITE SOLUTION IN HER EYE WHEN TRYING TO INJECT THE HYPOCHLORITE SOLUTION INTO TUBE 1 OF THE FLOWCELL ON THE CELL-DYN 3700. THE OPERATOR FLUSHED HER EYES IMMEDIATELY WITH THE EYEWASH. THE OPERATOR SOUGHT MEDICAL ATTENTION WITH NO DAMAGE FOUND. THE OPERATOR IS USING REWETTING EYE DROPS FOR IRRITATION, BUT OTHERWISE IS FINE. THE OPERATOR WAS NOT WEARING PROTECTIVE EYEWEAR WHEN THE SPLASH OCCURRED. NO ADDITIONAL OPERATOR INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 3700 CS ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1