BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOT APPLICABLE (INCIDENT OCCURRED IN WAREHOUSE)

    MDR report key: 1813496 · Received August 24, 2010

    Report

    Report Number
    2050012-2010-00616
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 24, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT A TOTAL BILIRUBIN REAGENT PACK LEAKED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOT APPLICABLE (INCIDENT OCCURRED IN WAREHOUSE) NOT APPLICABLE (INCIDENT OCCURRED IN WAREHOUSE) JJE BECKMAN COULTER INC. NA M904364

    Patients

    Seq Age Sex Outcome Treatment
    1