BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2993385 · Received March 7, 2013

    Report

    Report Number
    1061932-2013-00357
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBSERVING TRACES OF DRIED DILUENT ON THE ROCKER BELT AND STRIPPER PLATE AREA OF THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT AND GLOVES AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) OBSERVED A CRACK IN THE NEEDLE AND DILUENT SPRAYED OUT DURING THE NEEDLE RINSE. THE FSE INDICATED THAT THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE FSE REPLACED THE NEEDLE AND PERFORMED A BLOOD DETECTOR FOR NEEDLE VENT LINE CALIBRATION WITHOUT FURTHER ISSUE. REPAIR WAS VERIFIED AND RESULTS MET PUBLISHED SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97358 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1