BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® 4C® PLUS CELL CONTROL

    MDR report key: 1866114 · Received October 12, 2010

    Report

    Report Number
    1061932-2010-00174
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 13, 2010
    Report Date
    October 12, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JPK
    PMA / PMN Number
    K955016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPLACEMENT PRODUCT WAS PROVIDED. MSDS WAS REVIEWED AND AN EXPOSURE CONTROL PLAN IS IN PLACE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. PER PRODUCT LABELING, BECKMAN COULTER, INC. (BCI) URGES CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING AUTOMATED LABORATORY ANALYZER. A ROOT CAUSE FOR THIS EVENT WAS AN OPERATOR ERROR.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ABNORMAL CONTROL VIAL FROM COULTER 4C PLUS CELL CONTROL TRI-PACK THAT WAS DROPPED BY AN OPERATOR AND BROKE. PAPER TOWEL WAS USED TO CLEAN THE CONTROL SPILL. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), AND DID NOT SUSTAIN ANY CUTS OR INJURIES FROM THE BROKEN VIAL. NO DEATH OR INJURY WAS REPORTED FOR THIS EVENT. NO ONE SOUGHT MEDICAL ATTENTION, AND THERE WAS NO EFFECT TO ANY PATIENTS OR TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® 4C® PLUS CELL CONTROL HEMATOLOGY QUALITY CONTROL JPK BECKMAN COULTER, INC. NA 066400

    Patients

    Seq Age Sex Outcome Treatment
    1