BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 600 SYNCHRON CHEMISTRY ANALYZER

    MDR report key: 1771125 · Received July 27, 2010

    Report

    Report Number
    2122870-2010-00320
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 12, 2010
    Report Date
    July 23, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED DIAGNOSTIC TEST; ALL TESTS PASSED EXCEPT THE CARRYOVER TESTS. FSE REPLACED PARTS AND REPEATED THE CARRYOVER TEST. THE CUSTOMER SENT THE SAMPLE TO BECKMAN CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR ADDITIONAL TESTING. CPLS TESTING CONFIRMED A PATIENT SOURCE INTERFERENCE WITH A SAMPLE FROM THIS PATIENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS VITAMIN B12 RESULT ABOVE THE NORMAL REFERENCE RANGE UNICEL DXL 600 ACCESS 2 IMMUNOASSAY ANALYZER.PATIENT SAMPLE WAS REPORTED OUT OF THE LABORATORY.THE SAMPLE WAS REPEATED ON AN ALTERNATE METHOD AND LOWER RESULT WAS OBTAINED. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 600 SYNCHRON CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1