BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOT APPLICABLE (INCIDENT OCCURRED IN THE BCI WAREHOUSE)

    MDR report key: 1747260 · Received July 6, 2010

    Report

    Report Number
    2050012-2010-00406
    Event Type
    Malfunction
    Date Received
    July 6, 2010
    Date of Event
    May 28, 2010
    Report Date
    July 2, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER INFORMATION IS AVAILABLE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS DISCOVERED IN THE BECKMAN COULTER INC. (BCI) WAREHOUSE THAT A DIRECT BILIRUBIN (DBIL) AND AN AMYLASE (AMY) REAGENT PACK WAS LEAKING. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOT APPLICABLE (INCIDENT OCCURRED IN THE BCI WAREHOUSE) NOT APPLICABLE (INCIDENT OCCURRED IN THE BCI WAREHOUSE) JJE BECKMAN COULTER INC. NA M912294 (DBIL) M910708 (AMY)

    Patients

    Seq Age Sex Outcome Treatment
    1