BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 SLIDEMAKER ANALYZER

    MDR report key: 2537308 · Received April 16, 2012

    Report

    Report Number
    1061932-2012-01302
    Event Type
    Malfunction
    Date Received
    April 16, 2012
    Date of Event
    March 19, 2012
    Report Date
    March 19, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    CLASS1EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND THAT THE QUICK DISCONNECT (QD9) WAS LEAKING. THE FSE REPLACED THE QD9 AND VERIFIED OPERATION. PER LABELING, LH750 OPERATORS GUIDE PN4277249 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 IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT THERE WAS A SMALL CLEAR LIQUID LEAK ON THE RIGHT SIDE OF THE COULTER LH 750 SLIDEMAKER ANALYZER THAT WAS CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING A LAB COAT AND GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES AND THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THERE WAS NO IMPACT TO PATIENT RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1