BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® UREA REAGENT

    MDR report key: 2184712 · Received July 30, 2011

    Report

    Report Number
    2050012-2011-03860
    Event Type
    Malfunction
    Date Received
    July 30, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CDQ
    PMA / PMN Number
    K883181
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A REPLACEMENT WILL BE SENT TO THE CUSTOMER. BEC IDENTIFIER FOR THIS REPORT IS (B)(6).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THEIR SYNCHRON UREA REAGENT CARTRIDGE WAS BROKEN. NO INJURY WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® UREA REAGENT UREA NITROGEN TEST SYSTEM CDQ BECKMAN COULTER, INC. NA T011087

    Patients

    Seq Age Sex Outcome Treatment
    1