BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2379211 · Received December 16, 2011

    Report

    Report Number
    2050012-2011-08339
    Event Type
    Malfunction
    Date Received
    December 16, 2011
    Date of Event
    November 18, 2011
    Report Date
    November 18, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT AN ERRONEOUS CREATININE RESULT WAS GENERATED BY THE UNICEL DXC 800 SYNCHRON SYSTEM. CUSTOMER REPORTED THAT THE RESULT WAS REPORTED OUTSIDE THE LABORATORY. CUSTOMER REPORTED THAT THE TRI-CONTINENT SYRINGE WAS LEAKING. CUSTOMER REPORTED THAT THE RESULT WAS REPEATED AFTER IT WAS QUESTIONED BY THE DOCTOR THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. CUSTOMER REPORTED THAT THEIR BIO-MED ENGINEER REPLACED THE TRI-CONTINENT SYRINGE AND RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR