BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF PAK

    MDR report key: 2070020 · Received April 26, 2011

    Report

    Report Number
    1061932-2011-00303
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GGK
    PMA / PMN Number
    CLASS1EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT REAGENT. THE ROOT CAUSE IS UNKNOWN. PER PRODUCT LABELING, BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE CUSTOMER RECEIVED A COULTER ACT DIFF PAK REAGENT THAT WAS LEAKING FROM THE CAP. THE CUSTOMER WAS NOT WEARING ANY PERSONAL PROTECTIVE EQUIPMENT (PPE) UPON THE TIME RECEIVED. SOME OF THE FLUID WAS SPILLED ON THE CUSTOMER'S FOOT. THERE WAS NO AFFECT TO THE EXPOSED AREA. THERE WAS NO EXPOSURE TO OPEN LESION OR MUCUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER ACT DIFF PAK RED CELL LYSING REAGENT GGK BECKMAN COULTER, INC. NA 72107

    Patients

    Seq Age Sex Outcome Treatment
    1