BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 600 SYNCHRON CHEMISTRY ANALYZER

    MDR report key: 1935915 · Received December 22, 2010

    Report

    Report Number
    2122870-2010-00906
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION IS NOT AVAILABLE. PER CUSTOMER, BHCG QC RECOVERED WITHIN RANGE. SERVICE WAS NOT DISPATCHED A CLEAR ROOT CAUSE CAN BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT ERRONEOUSLY FALSE POSITIVE BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT ABOVE THE NORMAL REFERENCE RANGE FOR ONE PATIENT GENERATED BY UNICEL DXI 600 ACCESS 2 IMMUNOASSAY ANALYZER. THE RESULT WAS REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THE ORIGINAL SAMPLE WAS RETESTED AND LOWER RESULT WITHIN THE NORMAL REFERENCE RANGE WAS OBTAINED. PATIENT TREATMENT WAS NOT IMPACTED WITH REGARD TO 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. DXI 600 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR