BEUDAMED
    FDA Adverse Event Other Summary report: N

    EVOLIS MICROPLATE SYSTEM

    MDR report key: 1833825 · Received September 3, 2010

    Report

    Report Number
    3022521-2010-00003
    Event Type
    Other
    Date Received
    September 3, 2010
    Date of Event
    August 3, 2010
    Report Date
    September 2, 2010
    Manufacturer
    BIO-RAD LABORATORIES, INC
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) LABORATORIES DISTRIBUTES THE FOUR PLATE SYSTEM IN THE UNITED STATES UNDER THE EVOLIS TRADENAME.

    Description of Event or Problem · 1

    ON (B)(6) 2010 A CUSTOMER CONTACTED (B)(4) LABORATORIES TECHNICAL SUPPORT DEPARTMENT TO REPORT A PLATE TRANSPORT ERROR ON THE EVOLIS MICROPLATE PROCESSOR THAT LED TO AN INJURY. THE EVOLIS IS A 4-PLATE SELF-CONTAINED MICROPLATE PROCESSOR SYSTEM DESIGNED FOR USE WITH MULTIPLE EIA ASSAYS. THE CUSTOMER STATED THAT THE PLATE TRANSPORT MODULE WAS JAMMED INSIDE THE EVOLIS WASH MANIFOLD AND WHILE ATTEMPTING TO FIX THE PROBLEM THE CUSTOMER RECEIVED A CUT ON THE BACK OF THE HAND FROM THE ASPIRATE NEEDLES ON THE WASH MANIFOLD. AT THE TIME OF THE INCIDENT THE OPERATORS WERE WEARING GLOVES. THE EVOLIS WAS USED THE DAY BEFORE THE INCIDENT TO RUN THE GS (B)(4) PLUS O EIA ASSAY, AND THERE WERE NO (B)(4) REACTIVE PATIENT SAMPLES ON THAT RUN. THE CUSTOMER STATED THAT THE EVOLIS WAS NOT DISINFECTED AFTER THE RUN. THE INCIDENT WAS REPORTED TO THE OPERATOR'S SUPERVISOR AND OCCUPATIONAL HEALTH. THE CUSTOMER WAS COUNSELED AND TESTED FOR (B)(4) AT THAT TIME, AND FURTHER TESTING WILL BE PERFORMED AT 6 WEEKS, 3 MONTHS AND 6 MONTHS. THE CUSTOMER IS NOT ON ANY PROPHYLACTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVOLIS MICROPLATE SYSTEM 4PS (FOUR PLATE SYSTEM) JTC BIO-RAD LABORATORIES, INC EVOLIS

    Patients

    Seq Age Sex Outcome Treatment
    1