BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1810394 · Received August 20, 2010

    Report

    Report Number
    2122870-2010-00473
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 5, 2010
    Report Date
    August 20, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LGD
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TOXO IGG QC RESULTED WITHIN SPECIFICATION ON (B)(4) 2010 AND (B)(4) 2010. PATIENTS' SAMPLES NOT AVAILABLE FOR CUSTOMER PRODUCT LINE SUPPORT (CPLS) TO PERFORM ADDITIONAL TESTING. SERVICE WAS NOT DISPATCHED NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT ERRONEOUS REACTIVE TOXO IGG RESULTS ON TWO PATIENTS, WHICH WAS GENERATED BY UNICEL DXI 800 ACCESSS CHEMISTRY ANALYZER. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE INITIAL SAMPLES WERE REPEATED ON THE SAME UNIT THE FOLLOWING RESULTS WERE OBTAINED: PATIENT ONE (1) A NEGATIVE RESULT WAS OBTAINED PATIENT TWO (2) A REACTIVE RESULT WAS OBTAINED. A SECOND SAMPLE WAS TESTED FOR PATIENT TWO ON THE SAME UNIT (PRODUCED REACTIVE RESULT) AND ON AN ALTERNATE METHOD, WHICH PRODUCED NEGATIVE RESULT. IT IS UNKNOWN IF PATIENT TREATMENT WAS IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER LGD BECKMAN COULTER INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1