BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2183437 · Received July 28, 2011

    Report

    Report Number
    2050012-2011-03753
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K965240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: ERRONEOUS RESULTS GENERATED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT DISCREPANT GLUCM (GLUCOSE) RESULTS FOR TWO (2) PATIENT SAMPLES ASSAYED ON THE SYNCHRON LX20 CLINICAL CHEMISTRY SYSTEM. THE GLUCM RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO IMPACT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. EACH OF THE TWO (2) PATIENT SAMPLES WAS ASSAYED FOR GLUCM IN DUPLICATE. EACH PAIR OF DUPLICATE DETERMINATIONS YIELDED DISCREPANT RESULTS. THE CUSTOMER REPEATED THE GLUCM ASSAYS FOR THE TWO (2) PATIENT SAMPLES IN DUPLICATE ON THEIR OTHER SYNCHRON LX20 CLINICAL CHEMISTRY SYSTEM (SERIAL NUMBER (B)(4)). THESE REPEAT RESULTS WERE NOT DISCREPANT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE OBSERVED THAT THE REAGENT SYRINGE PUMP AND THE MODULAR CHEMISTRY SAMPLE SYRINGE WERE NOT FUNCTIONING PROPERLY. THE FSE REPLACED BOTH PARTS THEN VERIFIED ANALYZER PERFORMANCE PER ESTABLISHED PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 CLINICAL CHEMISTRY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. LX20

    Patients

    Seq Age Sex Outcome Treatment
    1