BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1665363 · Received April 22, 2010

    Report

    Report Number
    2050012-2010-00213
    Event Type
    Malfunction
    Date Received
    April 22, 2010
    Date of Event
    March 31, 2010
    Report Date
    April 22, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM IS ROUTINELY CALIBRATED EVERY 24 HOURS AND QC SAMPLES ARE RUN EVERY 8 HOURS. PRIOR TO THE EVENT, QC SAMPLES WERE WITHIN THE LAB'S ESTABLISHED RANGES. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY LOW SODIUM (NA) AND POTASSIUM (K) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS. UPON REPEAT ON A DIFFERENT INSTRUMENT THE SODIUM RESULTS WERE 7-8 MMOL/L HIGHER AND THE K RESULTS WERE 0.6-0.7 MMOL/L HIGHER. THE ORIGINAL RESULTS WERE DISCARDED AND THE HIGHER RESULTS WERE REPORTED. THE ACTUAL RESULTS HAVE NOT BEEN PROVIDED. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. PATIENT TREATMENT WAS NOT AFFECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1