BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT

    MDR report key: 2657012 · Received July 16, 2012

    Report

    Report Number
    2050010-2012-00020
    Event Type
    Malfunction
    Date Received
    July 16, 2012
    Date of Event
    June 28, 2012
    Report Date
    June 28, 2012
    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

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. BECKMAN COULTER INC.'S ASSESSMENT OF THE REAGENT REVEALED THAT THE CAUSE OF THE LEAK WAS A MISSING CAP. (B)(4).

    Description of Event or Problem · 1

    A BECKMAN COULTER INC. EMPLOYEE REPORTED A LEAK FROM ONE BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT. THE LEAKING SOLUTION WAS TOTAL BILIRUBIN REAGENT. THE PERSONNEL HANDLING THE KIT WERE WEARING PERSONAL PROTECTIVE EQUIPMENT WHICH INCLUDED SAFETY GLASSES AND GLOVES. THERE WAS NO REPORT OF ANY PERSONNEL SEEKING MEDICAL ATTENTION ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. NO PATIENT RESULTS WERE ASSOCIATED WITH THIS EVENT. THE FACILITY POSSESSED A RISK MANAGEMENT PLAN AND THE MATERIAL SAFETY DATA SHEET WAS REVIEWED.

    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. NA M112192

    Patients

    Seq Age Sex Outcome Treatment
    1