BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LD REAGENT

    MDR report key: 1937269 · Received December 23, 2010

    Report

    Report Number
    2050012-2010-01686
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CFJ
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THIS EVENT.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED THAT THE LD REAGENT LEAKED BECAUSE THERE WAS NO CAP. NO INJURY WAS REPORTED ON THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LD REAGENT LD REAGENT CFJ BECKMAN COULTER INC. NA M007474

    Patients

    Seq Age Sex Outcome Treatment
    1