BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® IMMUNOCHEMISTRY SYSTEM

    MDR report key: 1904809 · Received November 22, 2010

    Report

    Report Number
    2050012-2010-01331
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 18, 2010
    Manufacturer
    BECKMAN COUTLER INC.
    Product Code
    JJE
    PMA / PMN Number
    K962294
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW CONTAINER WAS SHIPPED OVERNIGHT. THE CUSTOMER REPLACED THE CONTAINER. SERVICE WAS NOT NEEDED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AFTER NOTICING A 10 LITER WASTE CONTAINER HAD A CRACK AND WAS LEAKING. THERE WAS NO REPORT OF EXPOSURE TO THE WASTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE® IMMUNOCHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COUTLER INC. IMMAGE NA

    Patients

    Seq Age Sex Outcome Treatment
    1