BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1953300 · Received January 7, 2011

    Report

    Report Number
    2050012-2011-00095
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS WERE RUN BEFORE AND AFTER THE INCIDENT. CUSTOMER TECHNICAL SUPPORT (CTS) SENT A REPLACEMENT REAGENT TO THE CUSTOMER. THE SYSTEM IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY, WHEN USING THE REPLACEMENT LAC REAGENT. ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING LOW LACTATE QC AND LOW LACTATE (LAC) PATIENT RESULTS THAT WERE GENERATED BY THE UNICEL DXC 600 SYNCHRON CHEMISTRY ANALYZER WHEN USING THE LAC REAGENT. THE CUSTOMER RAN QC AND PATIENT SAMPLES USING A REPLACEMENT REAGENT AND THE RESULTS RECOVERED ACCEPTABLY ON QUALITY CONTROLS AND ON THE PATIENT SAMPLES. PATIENT TREATMENT WAS NOT IMPACTED IN THIS EVENT AS NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1