BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITHIUM TEST KIT

    MDR report key: 2073433 · Received May 1, 2011

    Report

    Report Number
    2050012-2011-01152
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    NDW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS SENT REPLACEMENT.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED THAT LITHIUM KIT LEAKED INTO BOX. NO INJURY WAS REPORTED ON THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LITHIUM TEST KIT LITHIUM KIT NDW BECKMAN COULTER INC. NA M009352

    Patients

    Seq Age Sex Outcome Treatment
    1