BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 3122892 · Received May 21, 2013

    Report

    Report Number
    2919069-2013-00045
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K061667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(40. EYE INJURY. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE CUSTOMER'S ISSUE WAS RESOLVED BY CLEANING THE FLOW CELL. THE OPERATOR WAS CLEANING THE FLOW CELL WITH 5% HYPOCHLORIDE WHEN THE SPLASH OCCURRED. THE OPERATOR WAS NOT WEARING PROTECTIVE EYEWEAR DURING THE TROUBLESHOOTING PROCEDURE. A COLLEAGUE IMMEDIATELY WASHED THE OPERATOR'S EYE WITH WATER. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION AND STATED SHE WAS OK. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED SHE WAS SPRAYED IN HER EYE WITH BLEACH WHILE TROUBLESHOOTING A CELL-DYN RUBY ANALYZER FOR FALSELY DECREASED MCV RESULTS. THE CUSTOMER WAS NOT WEARING PROTECTIVE EYEWEAR AT THE TIME OF THE INJURY. THE CUSTOMER IMMEDIATELY CLEANED HER EYE WITH WATER AND DID NOT SEEK MEDICAL ATTENTION. THE FALSELY DECREASED MCV RESULTS WERE RESOLVED BY THE CLEANING. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT OR TO PERSONNEL REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224849 CELL-DYN RUBY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1