BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX@I 725 SYSTEM

    MDR report key: 2429640 · Received January 26, 2012

    Report

    Report Number
    2050012-2012-00237
    Event Type
    Malfunction
    Date Received
    January 26, 2012
    Date of Event
    January 3, 2012
    Report Date
    January 3, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE. THE FIELD SERVICE ENGINEER (FSE) CLEANED, ACID WASHED, CALIBRATED ALL CUVETTES, ALIGNED THE LAMP, ADJUSTED THE VOLTAGE, CALIBRATED ALL ASSAYS AND VERIFIED QUALITY CONTROL RESULTS. THE FSE PERFORMED A PRECISION RUN USING AN UNKNOWN SAMPLE AND THE RESULTS WERE WITHIN SPECIFICATIONS. THE INSTRUMENT WAS RETURNED INTO SERVICE. THE FSE PERFORMED SERVICE ON THE INSTRUMENT WHICH RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2012 ERRONEOUS TOTAL BILIRUBIN (TBIL) PATIENT RESULTS WERE PRODUCED ON A SYNCHRON LXI 725 CLINICAL SYSTEM FOR THREE PATIENTS. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THAT ALL THREE PATIENTS POSSESSED INITIAL TBIL RESULTS WHICH WERE LOW AND UPON REPEAT, THE REPEAT TBIL RESULTS WERE HIGHER. FOR THE THIRD PATIENT, MULTIPLE REPEAT RESULTS VARIED BOTH ABOVE AND BELOW THE INITIAL RESULT FOR THE SAMPLE. TWO OF THE REPEAT RESULTS FOR THE THIRD PATIENT WERE ASSOCIATED WITH THE USE OF DIFFERENT REAGENT CARTRIDGE. ADDITIONAL ANALYTE RESULTS WERE ALSO PROVIDED FOR THESE PATIENTS HOWEVER, THE CUSTOMER STATED THAT THERE WERE NO ISSUES WITH OTHER CHEMISTRIES. NONE OF THE INITIAL TBIL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER PERFORM A PRECISION RUN USING QUALITY CONTROL SAMPLES AND A DIFFERENT REAGENT CARTRIDGE FROM THE ONE INVOLVED IN THE EVENT. THE RESULTS WERE ACCEPTABLE. THE SAMPLES WERE PLASMA SAMPLES. 6. THE CUSTOMER STATED SEEING DIRTY CUVETTES, AND PERFORMED A CARTRIDGE CHEMISTRY CUVETTE WASH PROCEDURE. THE RESULTS OF A WATER BLANK TEST WERE NOT ACCEPTABLE. 7. INSTRUMENT CHEMISTRY QUALITY CONTROL RESULTS PERFORMED PRIOR TO THE EVENT WERE WITHIN CUSTOMER ESTABLISHED SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1