BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU5400 CLINICAL CHEMISTRY ANALYZER (AU5431-02 ANALYZER)

    MDR report key: 3100551 · Received May 8, 2013

    Report

    Report Number
    9612296-2013-00062
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K011720
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE REPLACED THE SYRINGES, WHICH RESOLVED THE LEAK ISSUE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) STATING THAT THE SYRINGE ON THE AU5431-02 CLINICAL CHEMISTRY ANALYZER (AU 5400 SERIES) WAS LEAKING. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT AND GLOVES AT THE TIME OF THE OCCURRENCE. THERE WAS NO REPORT OF INJURY OR EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200383 AU5400 CLINICAL CHEMISTRY ANALYZER (AU5431-02 ANALYZER) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER AU5431-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1