BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2184671 · Received July 30, 2011

    Report

    Report Number
    2050012-2011-03910
    Event Type
    Malfunction
    Date Received
    July 30, 2011
    Date of Event
    July 2, 2011
    Report Date
    July 1, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS CALIBRATED FOR MAGNESIUM (MG) AND QC WAS WITHIN THE ESTABLISHED RANGES. BEC FIELD SERVICE ENGINEER LOOKED AT REACTION WHEEL CUVETTE ABSORBANCES AND FOUND NUMBERS WERE HIGH AND ERRATIC. THE FSE FOUND MULTIPLE CUVETTES WERE VISUALLY DIRTY. THEY WERE CLEANED OR REPLACED. THE CUVETTE CENTERING PROCEDURE WAS COMPLETED. THE FSE INSPECTED OPTICS/PHOTOMETER. MOST LAMP READINGS WERE HIGH OR OUT OF RANGE. THE PHOTOMETER LAMP WAS REPLACED AND ALIGNED. THE FSE CALIBRATED ALL CHEMISTRIES. TWO QC RESULTS WERE NOT IN RANGE (CHEMISTRIES NOT IDENTIFIED). THE CUSTOMER WAS TO MONITOR. RELATED EVENTS ON (B)(6) 2011 ARE REPORTED IN MEDWATCH #2050012-2011-03909 AND 2050012-2011-03908, RESPECTIVELY.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BEC) THAT THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER GENERATED ERRONEOUSLY HIGH MAGNESIUM (MG) RESULTS. SOME OF THE RESULTS WERE REPORTED OUT OF THE LABORATORY. REPEAT TESTING ON AN ALTERNATE INSTRUMENT GENERATED LOWER RESULTS. THESE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY NOTIFICATION FROM PHYSICIANS OR HEALTHCARE PROVIDER THAT PATIENTS WERE TREATED BASED ON THE FALSE HIGH MG RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1