BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 2466314 · Received February 23, 2012

    Report

    Report Number
    2050012-2012-00511
    Event Type
    Malfunction
    Date Received
    February 23, 2012
    Date of Event
    January 29, 2012
    Report Date
    January 29, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE SYNCHRON LXI 725 CLINICAL SYSTEM (LXI 725) WAS GIVING BUN RX (BLOOD UREA NITROGEN REACTION NOISE) ERROR MESSAGE. CUSTOMER REPORTED THAT THEY LOADED A NEW REAGENT. CUSTOMER REPORTED THAT THE LXI 725 GAVE MODULAR CHEMISTRY (MC) REAGENT LEVEL LOW IN REACTION CUP ERRORS AFTER THEY LOADED A NEW REAGENT. 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 CUSTOMER TECHNICAL SPECIALIST ADVISED THE CUSTOMER TO CHECK FOR LEAKS. CUSTOMER REPORTED THAT THERE WAS A LEAK AROUND THE ELECTRODE. CUSTOMER REPORTED THAT THE ISSUE WAS RESOLVED AFTER REMOVING AND RESEATING THE ELECTRODE.

    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