BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT

    MDR report key: 2355639 · Received December 1, 2011

    Report

    Report Number
    2050012-2011-08151
    Event Type
    Malfunction
    Date Received
    December 1, 2011
    Date of Event
    November 3, 2011
    Report Date
    November 3, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CIG
    PMA / PMN Number
    K902801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TOTAL BILIRUBIN REAGENT IS CORROSIVE AND MAY CAUSE BURNS TO THE EYES, SKIN AND GASTROINTESTINAL TRACT AND SEVERE RESPIRATORY TRACT IRRITATION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE WAS WATER IN THE REAGENT COMPARTMENT OF THE UNICEL DXC 800 SYNCHRON SYSTEM. CUSTOMER REPORTED THAT THERE THE LIQUID LOOKED CRYSTALLIZED WHERE IT HAD DRIED. CUSTOMER REPORTED THAT QUALITY CONTROL (QC) LOOKED GOOD WHEN THEY LAST RAN ABOUT AN HOUR AGO. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND THE TOTAL BILIRUBIN REAGENT CARTRIDGE WAS CRACKED AT THE BOTTOM. THE FSE PUT IN NEW REAGENT TO AVOID CONTAMINATION AND CALIBRATED THEN PERFORMED QUALITY CONTROL.

    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.

    Patients

    Seq Age Sex Outcome Treatment
    1