BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 2361511 · Received December 7, 2011

    Report

    Report Number
    2050012-2011-08218
    Event Type
    Malfunction
    Date Received
    December 7, 2011
    Date of Event
    November 9, 2011
    Report Date
    November 9, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT ALL THE ION SELECTIVE ELECTROLYTES (ISE)S FAILED CALIBRATIONS AND BACK TO BACK ON THE SYNCHRON LXI 725 CLINICAL SYSTEM (LXI 725). THE CUSTOMER REPORTED THERE WAS AIR IN THE CARBON DIOXIDE (CO2) ACID CHAMBER CUSTOMER REPORTED THAT THE LXI 725 GENERATED ERRONEOUS RESULTS ON ONE PATIENT SAMPLE. CUSTOMER REPORTED THAT THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. CUSTOMER REPORTED THAT THE SAMPLE WAS RERUN ON A CX5 IN THE LABORATORY. CUSTOMER REPORTED THAT THE RESULTS RAN ON THE CX5 WERE REPORTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC CUSTOMER TECHNICAL SUPPORT INSTRUCTED THE CUSTOMER TO LOAD NEW ISE REFERENCE REAGENT, PRIME AND RECALIBRATE. NEW ISE REFERENCE REAGENT AND RECALIBRATION RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX I 725 CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. LX I 725 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR