BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 ANALYZER

    MDR report key: 2030092 · Received March 26, 2011

    Report

    Report Number
    1061932-2011-00190
    Event Type
    Malfunction
    Date Received
    March 26, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LOQ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE TUBING AT VL-62. ROOT CAUSE IS UNKNOWN FOR THIS EVENT. PER PRODUCT LABELING, BCI URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE LH 750 ANALYZER HAD A FLUID LEAK AT THE VALVE (VL-62) CORRESPONDING WITH THE DILUTER THAT MAY CONTAIN BLOOD, DILUENT, CLENZ OR CONTROL MATERIAL. THE CUSTOMER INDICATED THAT THE LEAK WAS OBSERVED ON THE COUNTER TOP AND APPEARED TO BE BLOODY. THERE WAS NO BLOOD EXPOSURE TO MUCOUS MEMBRANES (NOSE, EYES, AND MOUTH) OR OPEN WOUNDS AND NO ONE SOUGHT MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 750 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER LOQ BECKMAN COULTER, INC. LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1