BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON BILIRUBIN CALIBRATOR

    MDR report key: 2233826 · Received September 4, 2011

    Report

    Report Number
    2050012-2011-04701
    Event Type
    Malfunction
    Date Received
    September 4, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CIG
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPLACEMENT WAS SENT TO CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT TOTAL/DIRECT BILIRUBIN CALIBRATOR BOX WAS RECEIVED WET AND DAMAGED. THE CUSTOMER REFUSED TO ACCEPT THE BOX. NO INJURY OR EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON BILIRUBIN CALIBRATOR CALIBRATOR CIG BECKMAN COULTER INC. BILIRUBIN CAL M008649

    Patients

    Seq Age Sex Outcome Treatment
    1