BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1873155 · Received October 18, 2010

    Report

    Report Number
    2050012-2010-01012
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 18, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC RESULTS BETWEEN (B)(6) 2010 AND (B)(6) 2010 WERE ALL WITHIN THE ESTABLISHED RANGES. THREE ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER TO TROUBLESHOOT AND OFFER A SERVICE, BUT THE CUSTOMER DID NOT CALL BACK. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUSLY LOW SODIUM (NA) RESULT GENERATED BY UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE SUBSEQUENT TESTING PRODUCED HIGHER RESULT. THERE WAS NO EFFECT TO THE PATIENT OR TO THE USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1