BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN DIRECT BILIRUBIN REAGENT

    MDR report key: 2358908 · Received December 5, 2011

    Report

    Report Number
    2050012-2011-08165
    Event Type
    Malfunction
    Date Received
    December 5, 2011
    Date of Event
    November 6, 2011
    Report Date
    November 6, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CIG
    PMA / PMN Number
    K934068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DIRECT BILIRUBIN CONTAINS MATERIALS OF HUMAN OR ANIMAL ORIGIN AND SHOULD BE CONSIDERED AS POTENTIALLY CAPABLE OF TRANSMITTING INFECTIOUS DISEASES. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE NECK OF THE DIRECT BILIRUBIN REAGENT BOTTLE WAS BROKEN AND CAUSED LEAKAGE THERE WAS NO REPORT OF ERRONEOUS RESULTS GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN DIRECT BILIRUBIN REAGENT DIAZO COLORIMETRY, BILIRUBIN CIG BECKMAN COULTER, INC. M008649

    Patients

    Seq Age Sex Outcome Treatment
    1