BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX CO2 ACID REAGENT

    MDR report key: 2346574 · Received November 22, 2011

    Report

    Report Number
    2050012-2011-07844
    Event Type
    Malfunction
    Date Received
    November 22, 2011
    Date of Event
    October 25, 2011
    Report Date
    October 25, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JFL
    PMA / PMN Number
    K965240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC IS FILING THIS REPORT BECAUSE CO2 ACID REAGENT IS CORROSIVE, MAY CAUSE BURNS TO THE EYES, SKIN, RESPIRATORY TRACT AND GASTROINTESTINAL TRACT. STRONG INORGANIC ACID MISTS CONTAINING SULFURIC ACID MAY CAUSE CANCER. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THEY RECEIVED LEAKING CO2 REAGENT. CUSTOMER REQUESTED REPLACEMENT. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED OR REPORTED OUTSIDE THE LABORATORY. CUSTOMER REPORTED THAT NO INDIVIDUAL WAS TREATED MEDICALLY DUE TO EXPOSURE. 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 SYNCHRON LX CO2 ACID REAGENT PH RATE MEASUREMENT, CARBON-DIOXIDE JFL BECKMAN COULTER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1