BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF 2 ANALYZER

    MDR report key: 2367907 · Received December 12, 2011

    Report

    Report Number
    1061932-2011-02607
    Event Type
    Malfunction
    Date Received
    December 12, 2011
    Date of Event
    November 21, 2011
    Report Date
    November 21, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WASTE CONTAINER LEAKED. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011 CUSTOMER REPORTED THAT THE WASTE CONTAINER WAS LEAKING ON THE ACT DIFF 2 INSTRUMENT. NO INJURIES WERE REPORTED AND NO ERRONEOUS PATIENT RESULTS WERE GENERATED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A REPLACEMENT WASTE CONTAINER WAS SENT TO THE CUSTOMER. NO FURTHER ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER ACT DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. ACT DIFF 2

    Patients

    Seq Age Sex Outcome Treatment
    1