BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN TOTAL BILIRUBIN TRIGGERED KIT

    MDR report key: 2346699 · Received November 23, 2011

    Report

    Report Number
    2050012-2011-07857
    Event Type
    Malfunction
    Date Received
    November 23, 2011
    Date of Event
    November 3, 2011
    Report Date
    November 8, 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

    BECKMAN COULTER INC. ASSESSMENT OF THE SUPPLIED PHOTOS INDICATED THAT THE CARTRIDGES WERE LEAKING FROM THE BOTTOM SEAM. THIS MAY BE INDICATIVE OF A CARTRIDGE MANUFACTURING ISSUE. NO SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. A DEFINITIVE ROOT CAUSE FOR THE LEAK IS NOT KNOWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY OBSERVED A LEAK COMING FROM A BECKMAN TOTAL BILIRUBIN TRIGGERED KIT. NO PATIENT RESULTS WERE INVOLVED IN THIS EVENT. IT IS UNKNOWN AS TO WHETHER THE PERSONNEL INVOLVED IN THIS EVENT WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF OCCURRENCE HOWEVER NO PERSONNEL SOUGHT MEDICAL ATTENTION IN ASSOCIATION WITH THIS EVENT. THERE WAS NO CHEMICAL/BIOHAZARDOUS EXPOSURE TO PERSONNEL UNCOVERED WOUNDS OR MUCOUS MEMBRANES. NO DEATH, INJURY OR MODIFICATION TO PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT. IT IS UNKNOWN AS TO WHETHER THERE WAS A EXPOSURE CONTROL PLAN IN PLACE AT THE FACILITY OR IF THE MATERIAL SAFETY DATA SHEET WAS REVIEWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN TOTAL BILIRUBIN TRIGGERED KIT DIAZO COLORIMETRY, BILIRUBIN CIG BECKMAN COULTER, INC. NA Z106224

    Patients

    Seq Age Sex Outcome Treatment
    1