BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LXI 725 CLINICAL SYSTEM

    MDR report key: 2457743 · Received February 16, 2012

    Report

    Report Number
    2050012-2012-00449
    Event Type
    Malfunction
    Date Received
    February 16, 2012
    Date of Event
    January 17, 2012
    Report Date
    January 17, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE REPLACED THE CUVETTE WASH VALVE. THE REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT ERRONEOUS RESULTS FOR DIRECT BILIRUBIN, GLUCOSE, AND PHENCYCLIDINE FOR PATIENT SAMPLES ASSAYED ON A SYNCHRON LXI 725 CLINICAL SYSTEM. THE ERRONEOUS RESULTS FOR DIRECT BILIRUBIN, GLUCOSE, AND PHENCYCLIDINE WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO IMPACT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER REPORTED OBTAINING AN INSTRUMENT-GENERATED ERROR MESSAGE OF "OIR LOW" FOR THE DIRECT BILIRUBIN AND GLUCOSE ANALYSES. THE CUSTOMER REPORTED OBTAINING AN INSTRUMENT-GENERATED ERROR MESSAGE OF "OIR HI" FOR THE PHENCYCLIDINE ANALYSIS. THE CUSTOMER REPORTED THAT THE PATIENT SAMPLES WERE REASSAYED ON ANOTHER ANALYZER. NUMERICAL RESULTS WERE OBTAINED AND WERE WITHIN THE EXPECTED PATIENT RANGES. THE CUSTOMER REPORTED THAT THE REASSAY FOR GLUCOSE YIELDED A RESULT OF "AROUND 200-300 MG/DL". NO OTHER SPECIFIC PATIENT SAMPLE RESULTS WERE PROVIDED BY THE CUSTOMER. THE CUSTOMER REPORTED THAT QUALITY CONTROL RESULTS RECOVERED WITHIN THE LABORATORY'S ESTABLISHED RANGES BOTH PRIOR TO AND AFTER THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1