BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2213727 · Received August 16, 2011

    Report

    Report Number
    1061932-2011-01189
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) NOTED LEAK AT REAR OF THE DILUTOR AND IDENTIFIED TUBING AT THE UPPER SHEATH RESTRICTOR AS THE CAUSE OF THE LEAK (DILUENT AND CLENZ PASS THROUGH THE UPPER SHEATH RESTRICTOR). THE TUBING WAS REPLACED (DUE TO WEAR AND TEAR) WHICH RESOLVED THE ISSUE. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. THE BEC INTERNAL IDENTIFIER FOR THIS EVENT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CALLED BECKMAN COULTER INC. (BEC) REPORTING A LEAK AT THE REAR OF THE COULTER LH 780 HEMATOLOGY ANALYZER THAT APPEARED TO BE DILUENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE EVENT. NO INJURIES OCCURRED, NO EXPOSURE WAS REPORTED AND MEDICAL ATTENTION WAS NOT SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 780 HEMATOLOGY ANALYZER DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. LH 780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1