BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEMS

    MDR report key: 1641739 · Received March 26, 2010

    Report

    Report Number
    2050012-2010-00140
    Event Type
    Malfunction
    Date Received
    March 26, 2010
    Date of Event
    March 4, 2010
    Report Date
    March 26, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIMENS ARE DRAWN IN SERUM SEPARATOR TUBES. PRIOR TO THE EVENT, THE ISE SYSTEM WAS CALIBRATED AND NA QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES.A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: A) THE FSE PERFORMED A PREVENTIVE MAINTENANCE (PM).A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.(B)(4

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY HIGH SODIUM (NA) RESULTS GENERATED BY THE UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEMS.THE NA RESULTS WERE REPORTED OUT OF THE LAB AND QUESTIONED BY THE PHYSICIAN.SAMPLES FROM THE PREVIOUS 24 HOURS WERE REPEATED ON A DIFFERENT INSTRUMENT AND AMENDED REPORTS WERE ISSUED FOR NA. ONE PATIENT WAS TREATED WITH INTRAVENOUS SOLUTION BASED ON AN ERRONEOUS NA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JGS BECKMAN COULTER INC. DXC 600I

    Patients

    Seq Age Sex Outcome Treatment
    1