BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYXZER

    MDR report key: 3071860 · Received April 22, 2013

    Report

    Report Number
    1061932-2013-00627
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND OBSERVED BUBBLING NEAR THE DRAIN PORT OF THE MIXING CHAMBER. THE FSE REPLACED THE DIFFERENTIAL MIXING CHAMBER AND CYCLED A STARTUP AND QUALITY CONTROL (QC) WITH NO BUBBLING. NO FURTHER EVIDENCE OF LEAKING WAS OBSERVED, INSTRUMENT OPERATED WITHOUT INCIDENT. THE CAUSE OF THE LEAK WAS THE DIFF MIXING CHAMBER. THE INSTRUMENT OPERATED AS INTENDED BY GENERATING DIFFERENTIAL INCOMPLETE COMPUTATIONS ALERTING THE OPERATOR OF AN INSTRUMENT PROBLEM. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BECKMAN COULTER THAT THE COULTER LH 750 HEMATOLOGY ANALYZER WAS LEAKING UNDER THE MIXING CHAMBER AND GENERATING INCOMPLETE COMPUTATIONS FOR DIFFERENTIAL RESULTS. THE VOLUME OF THE LEAK IS UNKNOWN AND WAS CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THE LABORATORY'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF GLOVES, EYE PROTECTION, AND A LABORATORY COAT AT THE TIME OF THE OCCURRENCE. NO ONE CAME IN CONTACT WITH THE FLUID. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS RESULTS WERE GENERATED AS A RESULT OF THIS EVENT. THERE WAS NO DEATH OR INJURY REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171634 COULTER® LH 750 HEMATOLOGY ANALYXZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1