BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3072037 · Received April 22, 2013

    Report

    Report Number
    1061932-2013-00708
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED FLUID LEAKED UNDER THE LASER AREA. THE FSE REPLACED THE SAMPLE LINE (TUBING) FROM THE DIFFERENTIAL MIXING CHAMBER TO THE BOTTOM FITTING OF THE FLOWCELL TO RESOLVE THE ISSUE. SYSTEM PERFORMANCE WAS VERIFIED. 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 TWENTY (20) MILLILITERS OF FLUID LEAKED WITHIN THE INSTRUMENT UNDER THE FLOWCELL INVOLVING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE OPERATOR WAS WEARING 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 SAMPLES WERE NOT ANALYZED AT THE TIME OF THE EVENT, AND RESULTS WERE NOT GENERATED. THERE WAS NO PATIENT IMPACT. 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
    173162 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1