BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 2032824 · Received March 29, 2011

    Report

    Report Number
    2050012-2011-00900
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER NOTED SAMPLE REFERENCE AND SAMPLE NOISE ERRORS BCI CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING AND RECOMMENDED THE USE OF PERSONAL PROTECTIVE EQUIPMENT BEFORE TROUBLESHOOTING. THE CTS HAD CUSTOMER CLEAN THE EIC (ELECTROLYTE INJECTION CUP) AND CALIBRATE ISE (ION SELECTIVE ELECTRODE). THE CUSTOMER STATED THAT SODIUM (NA) WAS GETTING REFERENCE DRIFTS, AND THE CTS SUGGESTED CUSTOMER TO REMOVE NA REFERENCE ELECTRODE, DRY, TWIRL, DRY PORT, REINSERT, PRIME AND RECALIBRATE. THIS DID NOT RESOLVE THE ISSUE. THE CTS SUGGESTED CUSTOMER TO CHECK THE REAGENT, WHICH THE CUSTOMER FOUND LOW. THE CUSTOMER REPLACED THE ISE REFERENCE AND BUFFER, PRIMED AND RECALIBRATED SUCCESSFULLY. THE CUSTOMER WAS TO CALL IF PROBLEM CONTINUES. NO FURTHER COMPLAINT WAS FILED AS OF (B)(6) 2011. SERVICE WAS NOT DISPATCHED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO LIQUID SPLATTERS ON SYNCHRON LXI 725 CLINICAL SYSTEM. THE CUSTOMER STATED THAT THE LINE 26 WAS POPPING OFF AND THE PROBE GOES INTO EIC SPLATTERED LIQUID. THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX® I 725 CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. LXI 725 NA

    Patients

    Seq Age Sex Outcome Treatment
    1