BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1883274 · Received October 26, 2010

    Report

    Report Number
    2050012-2010-01088
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 26, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CALIBRATION AND QC ISSUES WERE REPORTED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO DISCREPANT DUPLICATE GLUCOSE (GLUCM) RESULTS GENERATED BY UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM FOR NUMEROUS SAMPLES. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AS THE RESULTS WERE CONFIRMED PRIOR TO RELEASING OUT OF THE LABORATORY. THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1