BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 1895659 · Received November 10, 2010

    Report

    Report Number
    1061932-2010-00209
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 12, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND THE WASTE PORT ON RINSE BLOCK CRACKED AND REPLACED THE RINSE BLOCK ASSEMBLY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) STATING THAT DURING INSTRUMENT OPERATION THE MANUAL PROBE RINSE BLOCK CRACKED AND LEAKED FLUID INSIDE THE INSTRUMENT HOUSING AND WAS CONTAINED WITHIN THE COULTER LH 780 HEMATOLOGY ANALYZER. THE RINSE BLOCK IS PART OF THE MANUAL PROBE ASSEMBLY AND CARRIES BLOOD, CLENZ, AND LYSE REAGENT. THE OPERATOR WAS WEARING A LAB COAT, EYEWEAR AND GLOVES. THERE WAS NO EXPOSURE TO SKIN, EYES, OPEN LESIONS, OR MUCOUS MEMBRANES. THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT AND NO MEDICAL TREATMENT WAS SOUGHT OUT BY THE OPERATOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1