BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2891091 · Received December 31, 2012

    Report

    Report Number
    1061932-2012-02920
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND EVALUATED THE SYSTEM. THE FSE OBSERVED A LEAK ORIGINATING FROM A CUT IN TUBING THAT PASSES THROUGH PINCH VALVE PV49. THE FSE REMOVED AND REPLACED THE CUT TUBING. SERVICE ACTIVITY PERFORMED IS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER INC THAT THEY HAVE A LEAK ON THE MANUAL PROBE AREA OF THE COULTER LH 500 HEMATOLOGY ANALYZER. APPROXIMATELY 6 DROPS OF CLEAR REAGENT LEAKED ONTO THE COUNTER. THERE WERE NO INJURIES OR EXPOSURES TO ANY LABORATORY PERSONNEL. THERE WERE NO ERRONEOUS RESULTS GENERATED. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL, GKZ BECKMAN COULTER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1