BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LX PRO HIGH SENSITIVITY CRP

    MDR report key: 2066336 · Received April 21, 2011

    Report

    Report Number
    2050012-2011-01230
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    NQD
    PMA / PMN Number
    K070626
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO LOOSENING OF THE CAP. THE LIQUID ADHERED TO THE BOTTLE. A CLEAR ROOT CAUSE IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A LIQUID LEAK OF THE LX PRO HIGH SENSITIVITY CRP REAGENT. INCIDENT OCCURRED AT BCI WAREHOUSE. NO INJURY WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LX PRO HIGH SENSITIVITY CRP LX PRO HIGH SENSITIVITY CRP NQD BECKMAN COULTER INC. N/A MO12386

    Patients

    Seq Age Sex Outcome Treatment
    1