BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER.

    MDR report key: 1802174 · Received August 17, 2010

    Report

    Report Number
    2050012-2010-00552
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 6, 2010
    Report Date
    August 13, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    QC SAMPLE RESULTS SHIFTED LOWER SINCE THE NEWER RF REAGENT LOT WAS USED. THE CUSTOMER RAN 2 DIFFERENT CALIBRATOR LOTS WITH THE NEW REAGENT LOT AND THE QC AND PATIENT RESULTS CORRELATED. A BCI ENGINEER CONFIRMED THAT THE ANALYZER WAS OPERATING WITHIN SPECIFICATIONS. A CLEAR ROOT CAUSE CANNOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A NEGATIVE BIAS ON PATIENT SAMPLE RESULTS (LOW SHIFT) BETWEEN NEW AND PREVIOUS LOT OF RHEUMATOID FACTORS (RF) REAGENT GENERATED BY UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER. CLINICAL CHEMISTRY ANALYZER, JJE BECKMAN COULTER INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1