BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 ANALYZER

    MDR report key: 2001945 · Received February 27, 2011

    Report

    Report Number
    1061932-2011-00106
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON 01/26/2011 AND REPAIRED SEVERAL LEAKS AROUND THE WHITE BLOOD COUNT (WBC) BATH. THE ROOT CAUSE IS RELATED TO INSTRUMENT REPAIRS PERFORMED SUBSEQUENT TO THIS EVENT. PER LABELING, BECKMAN COULTER, INC. 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 THERE WAS BLOOD COMING FROM THE CENTER AREA OF THE COULTER LH 750 ANALYZER. INITIAL INFORMATION INDICATED THAT THE BLOOD LEAK WAS CONTAINED WITHIN THE ANALYZER NEAR THE NEEDLE PROBE VACUUM. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER. THE OPERATOR DID NOT SEEK 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