BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOT APPLICABLE

    MDR report key: 1831466 · Received September 10, 2010

    Report

    Report Number
    2050012-2010-00722
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 15, 2010
    Report Date
    September 10, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT REPORT ANY SYSTEM ISSUES. REPLACEMENTS WERE SENT TO THE CUSTOMER. ALT: REAGENT MFG DATE: 02-03-2010. DBIL: PRODUCT CODE: JFM. REAGENT MFG DATE: 12-24-2009.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A DBIL AND ALT REAGENT PACK LEAK. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOT APPLICABLE NOT APPLICABLE JJE BECKMAN COULTER INC. N/A Z002006 (ALT) & Z912002 (DBIL)

    Patients

    Seq Age Sex Outcome Treatment
    1