BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ® LH750

    MDR report key: 2120818 · Received June 11, 2011

    Report

    Report Number
    1061932-2011-00613
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011 A BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE DIFFERENTIAL SAMPLE LINE PER ESTABLISHED PROCEDURES. FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES AND RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. ROOT CAUSE WAS ATTRIBUTED TO A DISCONNECTED DIFFERENTIAL SAMPLE LINE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT LEAK COMING FROM UNDER THE LASER AREA CONSISTING OF CLENZ, ISOTON, AND BLOOD. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, GLOVES AND EYE PROTECTION. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER ® LH750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER INC. LH750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1