BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN TOTAL BILIRUBIN TRIGGERED KIT

    MDR report key: 2346698 · Received November 23, 2011

    Report

    Report Number
    2050012-2011-07858
    Event Type
    Malfunction
    Date Received
    November 23, 2011
    Date of Event
    October 26, 2011
    Report Date
    November 9, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CKA
    PMA / PMN Number
    K883181
    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 SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGENT. 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 EXPOSURE TO PERSONNEL UNCOVERED WOUNDS OR MUCOUS MEMBRANES. NO DEATH, INJURY OR MODIFICATION TO PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT. NO EXPOSURE CONTROL PLAN WAS IN PLACE AT THE FACILITY. THE MATERIAL SAFETY DATA SHEET WAS NOT REVIEWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN TOTAL BILIRUBIN TRIGGERED KIT NADH OXIDATION/NAD REDUCTION, ALT/SGPT CKA BECKMAN COULTER, INC. NA Z104209

    Patients

    Seq Age Sex Outcome Treatment
    1