BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX CO2 ACID REAGENT

    MDR report key: 1938237 · Received December 27, 2010

    Report

    Report Number
    2050012-2010-01707
    Event Type
    Malfunction
    Date Received
    December 27, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JFL
    PMA / PMN Number
    K965240
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPLACEMENT REAGENT WAS SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A SPILL FROM SYNCHRON LX CO2 ACID REAGENT. A TECHNICIAN WAS EXPOSED TO THE SPILLED REAGENT. THE TECHNICIAN FLUSHED THE EXPOSED AREA WITH WATER AND DID NOT GO TO AN EMERGENCY ROOM. NO INJURY WAS REPORTED, AND THERE WAS NO EFFECT TO PATIENT OR USER.

    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. NA M010767

    Patients

    Seq Age Sex Outcome Treatment
    1