BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2222349 · Received August 25, 2011

    Report

    Report Number
    2050012-2011-04702
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION AS NOT PROVIDED. THE CUSTOMER REPORTED TO CUSTOMER TECHNICAL SUPPORT (CTS) THAT THEY OBSERVED THE BUNM ELECTRODE HAD THE WRONG QUAD RING ATTACHED (DESCRIBED AS THINNER AND SMALLER BY CUSTOMER) AND IT WAS LEAKING. THE CUSTOMER REPLACED THE ELECTRODE WITH ONE THAT HAD THE CORRECT QUAD RING. CTS SENT THE CUSTOMER A REPLACEMENT ELECTRODE. THE CUSTOMER DID NOT GENERATED SERVICE REQUEST.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) TO REPORT ERRONEOUS BUNM RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE ERRONEOUS SAMPLES WERE REPEATED ON ANOTHER INSTRUMENT; HOWEVER, THE CUSTOMER WAS UNABLE TO PROVIDE DATA. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER INC. DXC 800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1