BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH700 SERIES RETIC PAK

    MDR report key: 2013488 · Received March 10, 2011

    Report

    Report Number
    1061932-2011-00123
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GGK
    PMA / PMN Number
    CLASSIEXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE LEAK IS UNKNOWN.

    Description of Event or Problem · 1

    A BECKMAN COULTER INC. (BCI) WAREHOUSE EMPLOYEE REPORTED A DAMAGED RETIC PAK, UPON ARRIVAL. THE WAREHOUSE EMPLOYEE WAS WEARING GLOVES WHILE HANDLING THE LEAK AND THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS AND NO ONE SOUGHT MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH700 SERIES RETIC PAK AUTOMATED DIFFERENTIAL CELL COUNTER GGK BECKMAN COULTER INC. NA 57124K

    Patients

    Seq Age Sex Outcome Treatment
    1