BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIPASE (LIP)

    MDR report key: 2060433 · Received April 16, 2011

    Report

    Report Number
    2050012-2011-00916
    Event Type
    Malfunction
    Date Received
    April 16, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CHI
    PMA / PMN Number
    CL. I EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS SENT REPLACEMENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED THAT THEY RECEIVED LIPASE (LIP) REAGENT SHIPMENT AND ONE BOX OF LIP WAS LEAKING. A CART HAD THE LID ON THE A COMPARTMENT LOOSE. NO INJURY WAS REPORTED ON THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIPASE (LIP) LIPASE (LIP) CHI BECKMAN COULTER INC. NA M011632

    Patients

    Seq Age Sex Outcome Treatment
    1