BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2448424 · Received February 13, 2012

    Report

    Report Number
    1061932-2012-00414
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Date of Event
    January 24, 2012
    Report Date
    January 24, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC OFFERED TO SCHEDULE SERVICE; HOWEVER THE CUSTOMER REPLACED THE TUBING ON VALVE VL12 AND STATED THE UNIT IS WORKING FINE. THE ROOT CAUSE OF THE LEAK IS ATTRIBUTED TO THE LOOSE TUBING ON VL12A.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT WHILE TROUBLESHOOTING 'NO DIFFERENTIAL RESULTS' ON THEIR COULTER LH 750 HEMATOLOGY ANALYZER, THERE WAS A LEAK IN VALVE VL12A AND IT SPRAYED HER ON HER LAB COAT. SHE WAS WEARING A LAB COAT, GLOVES AND FACE SHIELD AT THE TIME OF THE INCIDENT. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES AND MEDICAL ATTENTION WAS NOT SOUGHT. NO PATIENT SAMPLES WERE AFFECTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1