BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2306943 · Received October 25, 2011

    Report

    Report Number
    2122870-2011-04892
    Event Type
    Malfunction
    Date Received
    October 25, 2011
    Date of Event
    September 25, 2011
    Report Date
    September 25, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER FOUND PRECIPITATE UNDERNEATH THE MAIN PIPETTOR WASH TOWER AND FELT LIQUID ON HER BARE FINGER WHILE INSPECTING. BEC CUSTOMER TECHNICAL SUPPORT (CTS) TROUBLESHOT VACUUM UNDER LIMIT ERROR WITH THE CUSTOMER AND HAD HER PRIMED THE PIPETTOR. THE CUSTOMER STATED THAT THE PIPETTOR PRIMED WITHOUT ISSUE AND WAS NOT OVERFLOWING WITH LIQUID AFTERWARD. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE ISSUE WAS RESOLVED BY TROUBLESHOOTING WITH CTS. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) OF COMING IN CONTACT WITH AN UNKNOWN LIQUID WHILE INSPECTING INTERIOR OF ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER WAS TROUBLESHOOTING VACUUM ERRORS ON THE INSTRUMENT. THE CUSTOMER WAS NOT WEARING GLOVES AND TOUCHED THE LIQUID WITH BARE FINGER. THE CUSTOMER WASHED HER HANDS WITH ANTI-BACTERIAL SOAP AND DID NOT SEEK MEDICAL ATTENTION. THE LIQUID THE CUSTOMER WAS EXPOSED TO COULD POTENTIALLY CONTAIN NOT ONLY WASH BUFFER BUT PATIENT SAMPLE WASTE, QC MATERIAL AND OTHER SUBSTANCES THAT ARE CONSIDERED CHEMICAL AND/OR BIOHAZARD IN NATURE. MSDS WAS NOT REVIEWED BUT THE FACILITY HAS AN EXPOSURE CONTROL AND RISK MANAGEMENT PLAN IN PLACE. NO HARM OR INJURY WAS REPORTED BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1