BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 1768679 · Received July 23, 2010

    Report

    Report Number
    2122870-2010-00344
    Event Type
    Malfunction
    Date Received
    July 23, 2010
    Date of Event
    June 21, 2010
    Report Date
    July 20, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES ARE COLLECTED IN 4ML BD LITHIUM HEPARIN TUBES AND CENTRIFUGED AT 3,000 RPM FOR 5 MINUTES. QC RESULTED WITHIN SPECIFICATIONS PRIOR TO AND AFTER THE EVENT. SAMPLES FROM THE PATIENT WERE TESTED BY BCI; ALL ACCUTNI RESULTS OBTAINED WERE ABOVE THE AMI CUT-OFF AND NO INTERFERENCE WAS DETECTED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE PERFORMED A PRECISION AND A DIAGNOSTIC TEST AND BOTH MET SPECIFICATIONS. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING AN ACCUTNI RESULT WITHIN THE RISK STRATIFICATION RANGE FROM ONE PATIENT'S THIRD SERIAL DRAW SAMPLE. AN ACCUTNI RESULT ABOVE THE AMI CUT-OFF WAS OBTAINED UPON REPEAT ANALYSIS. THE THREE ADDITIONAL SERIAL DRAWS FROM THE PATIENT GAVE ACCUTNI RESULTS ABOVE THE AMI CUT-OFF. THE RESULTS WERE REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT REPORT AFFECT TO THE PATIENT OR USER ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1