BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3090830 · Received May 2, 2013

    Report

    Report Number
    1061932-2013-00796
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THE SILICON TUBING HAD A HAIR-LINE TEAR WHICH CAUSED THE FLUID TO SPRAY INSIDE THE REAR DILUTER, BEHIND THE BATH ASSEMBLIES, AT THE 4-INCH RESTRICTOR LINE. THE FSE REPLACED THE TORN TUBING AND SEVERAL PINCH VALVE TUBING, IN THE REAR DILUTER PANEL, DUE TO EXCESSIVE WEAR. THE FSE NOTED QUALITY CONTROL (QC) RECOVERED WITHIN THE ACCEPTABLE LIMITS AND BACKGROUND COUNTS AND LATRON CONTROL RESULTS WERE ALSO WITHIN RANGE. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY THREE TO FIVE MILLILITERS OF CLEAR FLUID LEAKED INSIDE THE INSTRUMENT DURING LATRON CONTROL ANALYSIS INVOLVING THE COULTER LH 500 HEMATOLOGY ANALYZER. THE OPERATOR WAS WEARING PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND EYE PROTECTION AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ALL QUALITY CONTROL (QC) RESULTS RECOVERED WITHIN THE ACCEPTABLE LIMITS. THE LABORATORY HAS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191612 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1