BEUDAMED
    FDA Adverse Event Other Summary report: N

    EVOLIS MICROPLATE SYSTEM

    MDR report key: 1744668 · Received June 25, 2010

    Report

    Report Number
    3022521-2010-00001
    Event Type
    Other
    Date Received
    June 25, 2010
    Date of Event
    May 27, 2010
    Report Date
    June 24, 2010
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Product Code
    JJQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2010 A CUSTOMER CONTACTED (B)(4) LABORATORIES TECHNICAL SUPPORT DEPARTMENT TO REPORT THAT WHILE WIPING THE SURFACE UNDERNEATH THE EVOLIS WASH MANIFOLD, WITH DISINFECTANT, SHE CUT THE BACK OF HER HAND WITH ONE OF THE ASPIRATE NEEDLES. THE EVOLIS IS A 4-PLATE SELF-CONTAINED MICROPLATE PROCESSOR SYSTEM DESIGNED FOR USE WITH MULTIPLE EIA ASSAYS. THE CUSTOMER STATED THAT AT THE TIME OF THE INCIDENT SHE WAS WEARING GLOVES. THE DAY OF THE INCIDENT THE EVOLIS WAS USED TO RUN THE FOLLOWING ASSAYS: GS (B)(4) PLUS O EIA, GS (B)(4) EIA 3.0 AND ORTHO HCV VERSION 3.0 ELISA TEST SYSTEM. THE CUSTOMER STATED THAT THERE WERE NO REACTIVE SAMPLES FOR THE GS (B)(4) PLUS O EIA AND THE GS (B)(4) EIA 3.0 ASSAYS. HOWEVER, THE CUSTOMER REPORTED THAT THE ORTHO HCV VERSION 3.0 ELISA ASSAY RUN HAD 3 REACTIVE PATIENT RESULTS. THE CUSTOMER REPORTED THE INCIDENT TO THE FACILITIES MEDICAL OFFICER. THE CUSTOMER ALSO SAW A PHYSICIAN AND THEY ARE DOING BASELINE TESTING 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) JJQ BIO-RAD LABORATORIES, INC. EVOLIS

    Patients

    Seq Age Sex Outcome Treatment
    1