BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF PAK

    MDR report key: 1938355 · Received December 27, 2010

    Report

    Report Number
    1061932-2010-00313
    Event Type
    Malfunction
    Date Received
    December 27, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GGK
    PMA / PMN Number
    CLASS1EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT REPLACEMENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT WHEN THE COULTER ACT DIFF PAK WAS LIFTED TO BE PLACED ON THE COUNTER, IT WAS LEAKING SOME FLUID. THE CUSTOMER ALSO STATED THAT THE BOX THAT HOLDS THE REAGENT DID NOT APPEAR DAMAGED BUT AFTER CONNECTING THE REAGENTS AND TILTING THE BOX TO PLACE IT ON THE SHELF, THEY NOTICED SOME FLUID ON THE CORNER OF THE CARDBOARD CONTAINER. THE OPERATOR WAS WEARING GLOVES WHILE HANDLING THE CONTAINER AND NOBODY CAME IN CONTACT WITH THE LEAKED REAGENT. NO INJURY WAS REPORTED AND MEDICAL ATTENTION WAS NOT NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER ACT DIFF PAK RED CELL LYSING REAGENT GGK BECKMAN COULTER INC. NA 114182K

    Patients

    Seq Age Sex Outcome Treatment
    1