BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 ANALYZER

    MDR report key: 1982048 · Received February 8, 2011

    Report

    Report Number
    1061932-2011-00072
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LOQ
    PMA / PMN Number
    K011324
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND REPLACED TWO CHECK VALVES IN THE NEEDLE WASTE LINE. PERFORMANCE OF THE ANALYZER WAS VERIFIED. THE ROOT CAUSE WAS TWO BAD CHECK VALVES ON NEEDLE WASTE LINE. AS PER PRODUCT 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 THE STRIPPER PLATE SPLASHED BLOOD ONTO THE BARCODE READER ON THE COULTER LH750 ANALYZER. WHEN BLOOD GETS ON THE BARCODE READER, IT IS CLEANED WITH DISINFECTANT. ALL OPERATORS WEAR PERSONAL PROTECTIVE EQUIPMENT (PPE). THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION AND PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT.

    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