BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2030011 · Received March 25, 2011

    Report

    Report Number
    2050012-2011-00806
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC HAS CONSISTENTLY BEEN WITHIN LAB-ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT; NO ISSUES WERE FOUND. THE SYSTEM PASSED ALL PERFORMANCE TESTS. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. NOTE: CUSTOMER HAS TWO UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS IN THEIR LAB. THEY CANNOT IDENTIFY WHICH OF THEIR TWO INSTRUMENTS GENERATED THE RESULTS; THEREFORE TWO MDR REPORTS WERE GENERATED TO COVER BOTH ANALYZERS. MDR REPORT #: 2050012-2011-00807 IS FOR THE OTHER UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS, (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND REPORTED THAT PHYSICIANS QUESTIONED SODIUM (NA) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS ON TWENTY ONE PATIENT SAMPLES, FROM THE PREVIOUS TWO WEEKS. THE PHYSICIANS FELT THAT THE NA RESULTS WERE TOO LOW BASED ON THE PATIENTS' HISTORICAL RECOVERY. THE CUSTOMER REVIEWED THE DATA AND STATED THAT THERE WAS AN AVERAGE DECREASE OF ABOUT 4.5MMOL/L. NO SAMPLES WERE REPEATED. IT IS UNKNOWN HOW LONG AGO THE PREVIOUS SAMPLES (ON WHICH THE PHYSICIANS BASE THEIR INQUIRES) WERE RUN AND REPORTED. TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE REPORTED RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JGS BECKMAN COULTER INC. DXC 800 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1