BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX 20 PRO CLINICAL SYSTEMS

    MDR report key: 1964401 · Received January 19, 2011

    Report

    Report Number
    2050012-2011-00194
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC RESULTS ARE OUT OF SPECIFICATION AND THE ISE SYSTEM DOES NOT CALIBRATE. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED THE FOLLOWING: CLEANED THE FLOW CELL AND ELECTROLYTE INJECTION CUP (EIC) CUP REPLACED THE SAMPLE PROBE AND CARBON BRIDGE REBUILT THE RATIO PUMP REPLACED A LEAKING MODULAR CHEMISTRY T VALVE. FSE CALIBRATED THE UNIT AND RAN 10 REPS OF BOTH HIGH AND LOW CONTROL. PRECISION WAS WITHIN SPECIFICATIONS. PER CUSTOMER, ON (B)(4) 2011, THE ISSUE HAS BEEN RESOLVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO 25 ERRONEOUS LOW SODIUM (NA) RESULTS GENERATED BY THE SYNCHRON LX 20 PRO CLINICAL SYSTEMS. IN ADDITION, QC RESULTS WERE OUT OF SPECIFICATION AND UNABLE TO CALIBRATE THE ION-SELECTIVE ELECTRODE (ISE). THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE RESULTS WERE LOW BY 2 TO 5 UNITS FOR 23 OF THE SAMPLES AND UP TO 10 UNITS FOR TWO SAMPLES. PATIENT RESULTS ARE NOT AVAILABLE. PATIENT'S TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX 20 PRO CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LX-20 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1