BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2497556 · Received March 20, 2012

    Report

    Report Number
    2050012-2012-00741
    Event Type
    Malfunction
    Date Received
    March 20, 2012
    Date of Event
    February 24, 2012
    Report Date
    February 24, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION - RESULTS: AUTOGLOSS. BEC IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THEY NOTICED CLEAR FLUID UNDER THE CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE ON THE SAMPLE WHEEL PLASTIC COVER OF THE UNICEL DXC 600 SYNCHRON SYSTEM. CUSTOMER REPORTED THAT THE FLUID APPEARED TO BE DEIONIZED WATER. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND THAT INSUFFICIENT AUTOGLOSS CAUSED THE PROBE TO BE MISALIGNED. THE FSE RESOLVED THE AUTOGLOSS ISSUE AND REPLACED THE BLADE, THE SAMPLE PROBE AND PERFORMED ALIGNMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600 SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1