BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX3 DELTA CLINICAL SYSTEM

    MDR report key: 1945118 · Received January 3, 2011

    Report

    Report Number
    2050012-2011-00019
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJF
    PMA / PMN Number
    K942676
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT REAGENT WAS SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE CREATININE (C) REAGENT BOTTLE HAD A LOOSE CAP AND LEAKED INTO THE CONTAINMENT BAG. NO INJURY WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX3 DELTA CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJF BECKMAN COULTER INC. CX3 DELTA NA

    Patients

    Seq Age Sex Outcome Treatment
    1