BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2925901 · Received January 22, 2013

    Report

    Report Number
    1061932-2013-00109
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED THE BLOOD SAMPLING VALVE (BSV) PROBE SLIGHTLY BENT AND THE WIPER BLOCK MISALIGNED. THE FSE STRAIGHTENED THE PROBE AND ADJUSTED THE WIPER ALIGNMENT TO RESOLVE THE ISSUE. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY THREE (3) MILLILITERS OF CLEAR FLUID LEAKED OUTSIDE THE INSTRUMENT FROM THE BLOOD SAMPLING VALVE (BSV) MANUAL PROBE WIPE RINSE BLOCK INVOLVING THE COULTER LH 500 HEMATOLOGY ANALYZER. THE CUSTOMER HAD ON PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT RESULTS WERE NOT IMPACTED AND NO ERRONEOUS RESULTS WERE GENERATED. PATIENT SAMPLES WERE REANALYZED ON AN ALTERNATE ANALYZER AND RESULTS CORRELATED. THE CUSTOMER STOPPED OPERATING IN THE MANUAL MODE WHEN THE FLUID LEAK WAS DISCOVERED. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29706 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1