BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX CLINICAL SYSTEM, MODEL LX20 PRO

    MDR report key: 2419519 · Received January 18, 2012

    Report

    Report Number
    2050012-2012-00126
    Event Type
    Malfunction
    Date Received
    January 18, 2012
    Date of Event
    December 16, 2011
    Report Date
    December 22, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGJ
    PMA / PMN Number
    K014034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE INSTRUMENT ISSUE IS UNKNOWN; HOWEVER, THE INSTRUMENT ISSUE WAS RESOLVED AFTER THE FSE PERFORMED THE SERVICES.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT THE SYNCHRON LX CLINICAL SYSTEM, MODEL LX20 PRO, GENERATED FALSELY HIGH MAGNESIUM RESULTS FOR FOUR PATIENT SAMPLES. CUSTOMER STATED THAT THE PROBLEM APPEARED TO BE INSTRUMENT RELATED AS CUSTOMER NOTICED WHILE PERFORMING MAINTENANCE THAT THE WIPER PIECES WERE MISSING, AND BELIEVED THAT THE CUVETTES WERE CRACKED AND THAT THERE WAS AN ALIGNMENT ISSUE. THE CUSTOMER TECHNICAL SPECIALIST (CTS) GENERATED A SERVICE REQUEST. CUSTOMER STATED THAT THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. AFTER THE ISSUE WAS NOTICED, THE PATIENT SAMPLES WERE RERUN, THE RESULTS OF WHICH WERE REPORTED; THEREFORE, PATIENT TREATMENT WAS NOT AFFECTED. ON (B)(6) 2011, THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND ORDERED THE PARTS THAT REQUIRED REPLACEMENT. THE FSE RETURNED ON (B)(6) 2011 TO REPLACE THE PHOTOMETER ASSEMBLY AND TO PERFORM ALL NECESSARY ALIGNMENTS. THE FSE RETURNED THE NEXT DAY WITH MORE PARTS AND REPLACED THE CARTRIDGE CHEMISTRY (CC) SAMPLE SYRINGE DRIVE ASSEMBLY, CC SAMPLE AND REAGENT MIXER WASH ASSEMBLIES, AND CC MIXER BEARINGS. THE FSE THEN PERFORMED ALIGNMENTS AND RAN QUALITY CONTROLS, THE RESULTS OF WHICH WERE WITHIN RANGE. FINALLY, THE FSE RETURNED ON (B)(6) 2011 TO CHANGE TO SYRINGE DRIVE, MIXER BEARINGS, WASH INSERTS, AND SAMPLE CLOG DETECTOR. ONCE AGAIN, THE FSE PERFORMED ALIGNMENTS AND RAN QUALITY CONTROLS WITHOUT FINDING ANY ERRORS. THE FSE VERIFIED INSTRUMENT PERFORMANCE PER ESTABLISHED PROCEDURES TO ENSURE THAT THE SERVICES PERFORMED EFFECTIVELY RESOLVED THE INSTRUMENT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX CLINICAL SYSTEM, MODEL LX20 PRO ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGJ BECKMAN COULTER, INC. LX20 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1