BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER LAB AUTOMATION SYSTEM

    MDR report key: 1647444 · Received March 31, 2010

    Report

    Report Number
    2050012-2010-00148
    Event Type
    Malfunction
    Date Received
    March 31, 2010
    Date of Event
    March 5, 2010
    Report Date
    March 31, 2010
    Manufacturer
    BECKMAN COULTER BIOMEDICAL GMBH
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ERROR WAS IDENTIFIED BY THE CUSTOMER UPON OCCURRENCE VIA NOTIFICATION FROM A SECONDARY SOFTWARE TOOL IN OPERATION AT THE FACILITY. ERROR IS INDICATED BY THE PRESENCE OF TWO SAMPLE IDS FOR THE SAME PLATE AND WELL. SOFTWARE LOG FILES FROM THE ASSOCIATED DEVICE WERE EVALUATED DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING TWO DIFFERENT SAMPLES BEING PIPETTED INTO THE SAME WELL OF A MICROTITER PLATE ON THE AUTOMATE 2500 WITH SERUM PLATES AND AUTOMATED RACK CODE READER. THE ISSUE WAS IMMEDIATELY NOTICED AND THE AFFECTED WELLS WERE NOT FURTHER PROCESSED. THERE WAS NO EFFECT TO PATIENT AND USER ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER LAB AUTOMATION SYSTEM LAB AUTOMATION JQP BECKMAN COULTER BIOMEDICAL GMBH AUTOMATE 2550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1