BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIFF ACT TAINER REAGENT

    MDR report key: 2225128 · Received August 29, 2011

    Report

    Report Number
    1061932-2011-01288
    Event Type
    Malfunction
    Date Received
    August 29, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GGK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS SENT A REPLACEMENT BOTTLE. PER 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 IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. BEC IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT A DIFF ACT TAINER REAGENT (REAGENT #2) HAD LEAKED IN THE COULTER AC*T 5 DIFF ANALYZER. THE CUSTOMER INSPECTED THAT ALL THREE REAGENT BOTTLES AND THERE WAS NO DAMAGE OBSERVED. THE CUSTOMER INSPECTED REAGENT # 2 BOTTLE AND OBSERVED THAT THE SEAL WAS IN PLACE AND THAT THE LEAK WAS ABSORBED BY THE DIFF ACT TAINER BOX. CUSTOMER WORE GLOVES TO HANDLE THE BOTTLE AND BOX. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WAS NO DEATH, INJURY ATTRIBUTED OR CONNECTED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIFF ACT TAINER REAGENT PRODUCTS, RED-CELL LYSING PRODUCTS GGK BECKMAN COULTER, INC. N/A 115130K

    Patients

    Seq Age Sex Outcome Treatment
    1