BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT

    MDR report key: 2311799 · Received October 27, 2011

    Report

    Report Number
    2050012-2011-06552
    Event Type
    Malfunction
    Date Received
    October 27, 2011
    Date of Event
    September 28, 2011
    Report Date
    September 28, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CIG
    PMA / PMN Number
    K902801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC IS FILING THIS MDR BECAUSE TOTAL BILIRUBIN CALIBRATOR 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 ONE SMALL BOTTLE OF TOTAL BILIRUBIN CALIBRATOR HAD CRACKED AT THE WAREHOUSE. THERE WAS NO REPORT OF ERRONEOUS RESULTS GENERATED OR REPORTED OUTSIDE THE LABORATORY. 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 TOTAL BILIRUBIN TRIGGERED (TB-T) KIT DIAZO COLORIMETRY, BILIRUBIN CIG BECKMAN COULTER, INC. M008649

    Patients

    Seq Age Sex Outcome Treatment
    1