BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU5421-02 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2355647 · Received December 1, 2011

    Report

    Report Number
    2050012-2011-08204
    Event Type
    Malfunction
    Date Received
    December 1, 2011
    Date of Event
    November 2, 2011
    Report Date
    November 2, 2011
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K011720
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE TRAINER STATED THAT THE CONTROLS THAT WERE BEING USED WERE NEGATIVE FOR INFECTIOUS DISEASES. THE CUSTOMER DECLINED FOLLOW-UP AT MEDICAL CLINIC.

    Description of Event or Problem · 1

    A CUSTOMER WAS IN TRAINING AT BECKMAN COULTER INC. (BEC) AND WAS PERFORMING DAILY STARTUP AND WHILE INSTRUMENT WAS RUNNING CLEANING SOLUTION, THE CUSTOMER NOTICED COVER SLIGHTLY OUT OF PLACE AND REACHED IN TO ADJUST COVER AND THE PROBE HIT HIS HAND. THE PROBE BENT AND HIS INDEX FINGER WAS PINCHED WHICH RESULTED IN A CUT. THE CUSTOMER DECLINED GOING TO THE NURSE AND SAID HE WAS FINE. SYSTEM PERFORMANCE WAS NOT AFFECTED AND DID NOT CONTRIBUTE TO THE INCIDENT. THE CUSTOMER HAD BEEN WARNED ABOUT MOVING PARTS AND POTENTIAL RISK DURING TRAINING. PER PRODUCT LABELING, AU680 USER'S GUIDE VOL I PAGE 2.5 SECTION 2.1.5 PREVENTING PERSONAL AND SERIOUS INJURY. WHILE THE SYSTEM IS IN OPERATION DO NOT TOUCH ANY MOVING PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU5421-02 CLINICAL CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. AU5421-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1