BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3212149 · Received July 8, 2013

    Report

    Report Number
    1061932-2013-01334
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED FOR A THIRD PARTY SERVICE TO EVALUATE THE INSTRUMENT. THE CUSTOMER STATED THAT A TUBING HAD POPPED OFF THE FLOW CELL AND THE THIRD PARTY SERVICE ENGINEER REPLACED THE TUBING TO THE FLOW CELL TO RESOLVE THE LEAK. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO A TUBING WHICH HAD POPPED OFF THE FLOW CELL AND THE THIRD PARTY SERVICE PROVIDER REPLACED THE TUBING TO THE FLOWCELL TO RESOLVE THE LEAK. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCOVERING A CLEAR FLUID LEAK OF APPROXIMATELY 20 ML NEAR THE DIFFERENTIAL MIXING CHAMBER AREA AND UNDER THE COULTER LH 750 HEMATOLOGY ANALYZER AFTER OBTAINING NON-NUMERIC (.....) CODES FOR THE DIFFERENTIALS ON QC (QUALITY CONTROL). THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, A LABORATORY COAT, AND PROTECTIVE EYEWEAR AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS PATIENT RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308707 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1