BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT

    MDR report key: 2163013 · Received July 15, 2011

    Report

    Report Number
    2050012-2011-02792
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CIG
    PMA / PMN Number
    K902801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION WAS SUPPLIED REGARDING THIS EVENT.

    Description of Event or Problem · 1

    BECKMAN COULTER INC, (BEC) WAREHOUSE IN (B)(4) REPORTED THAT THE CX TOTAL BILIRUBIN REAGENT WAS LEAKING DUE TO A CRACK AT THE BOTTOM OF THE CARTRIDGE. NO INJURY WAS REPORTED ON THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT TOTAL BILIRUBIN (TBIL) CIG BECKMAN COULTER INC. NA M103151

    Patients

    Seq Age Sex Outcome Treatment
    1