BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOT APPLICABLE (INCIDENT OCCURRED IN BCI WAREHOUSE)

    MDR report key: 1897147 · Received November 11, 2010

    Report

    Report Number
    2050012-2010-01268
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 11, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS DISCOVERED IN THE BECKMAN COULTER INC. (BCI) WAREHOUSE THAT A TBIL KIT WAS RECEIVED LEAKING. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOT APPLICABLE (INCIDENT OCCURRED IN BCI WAREHOUSE) NOT APPLICABLE (INCIDENT OCCURRED IN BCI WAREHOUSE) JJE BECKMAN COULTER INC. NA Z006027

    Patients

    Seq Age Sex Outcome Treatment
    1