BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2240203 · Received September 9, 2011

    Report

    Report Number
    2050012-2011-05086
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS ADDRESSED WHEN THE CUSTOMER TIGHTENED THE REAGENT SYRINGE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) CUSTOMER TECHNICAL SUPPORT (CTS) TO REPORT A LEAK FROM THE REAGENT SYRINGE OF A UNICEL DXC 800 SYNCHRON SYSTEM. PER CTS' INSTRUCTIONS, THE CUSTOMER TIGHTENED THE REAGENT SYRINGE AND THE ISSUE WAS RESOLVED. PER THE CUSTOMER, NO ERRONEOUS PATIENT RESULTS WERE GENERATED. NO EFFECT TO PATIENT OR USER WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1