BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM (PACKAGED)

    MDR report key: 2232113 · Received September 1, 2011

    Report

    Report Number
    2050012-2011-04770
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    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 CALLED BEC CTS (CUSTOMER TECHNICAL SUPPORT) AND STATED SHE JUST REPLACED THE POTASSIUM (K) AND CALCIUM (CA) TIP. SHE THEN RAN CALIBRATION AND K AND CA FAILED DUE TO REACTION NOISE. CTS ASKED CUSTOMER IF EVERYTHING WAS RECONNECTED FIRMLY AND CORRECTLY PER PROCEDURES AND ALSO ASKED CUSTOMER TO WEAR PERSONAL PROTECTIVE EQUIPMENT (PPE) AND PRIME ISE FLOW CELL WITH ISE REFERENCE BUFFER 10 TIMES. DURING PRIMING IT WAS DISCOVERED THAT THE CA TIP WAS NOT TIGHTENED ALL THE WAY AND HAD A SLIGHT LEAK. ONCE TIGHTENED, THE CUSTOMER DID NOT HAVE ANY FURTHER LEAKING ISSUES. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REGARDING A SLIGHT LEAK THAT WAS OBSERVED WHILE TROUBLESHOOTING THE UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM FOR ISE (ION-SELECTIVE ELECTRODE) CALIBRATION ISSUE. NO INJURY WAS REPORTED AND NO ERRONEOUS PATIENT RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM (PACKAGED) CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1