BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1932548 · Received December 18, 2010

    Report

    Report Number
    2050012-2010-01609
    Event Type
    Malfunction
    Date Received
    December 18, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC AND CALIBRATION RESULTS WERE ACCEPTABLE PRIOR TO THE EVENT. PHOSPHOROUS (PHOSM) REAGENT LINES WERE FULL OF PRECIPITATE. A BCI FIELD SERVICE ENGINEER (FSE) REPLACED ALL REAGENT LINES TO INCLUDE CAP AND STRAW, AND REAGENT PRE-HEATER TUBING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUSLY HIGH PHOSPHOROUS (PHOSM) RESULT GENERATED BY UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. THE RESULT FAILED THE DELTA CHECK AND WAS NOT REPORTED OUT OF THE LABORATORY. REPEAT TESTING PRODUCED LOWER RESULTS. THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. DXC800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1