BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 ANALYZER

    MDR report key: 2133175 · Received June 20, 2011

    Report

    Report Number
    1061932-2011-00712
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND INDICATED A LEAK AT THE MANUAL MODE PROBE. TO RESOLVE THIS ISSUE THE MANUAL MODE PROBE AND THE FLUID CATCH BOX (DRIP TRAY) WERE ADJUSTED BY THE FSE. REPAIRS PER ESTABLISHED PROCEDURES WERE VERIFIED AND RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE FOR THE LEAK WAS ASSOCIATED TO THE MANUAL MODE PROBE. 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) REPORTING A BLOOD FLUID LEAK (5ML) IN THE DRIP TRAY UNDER THE MANUAL SAMPLING PROBE OF THE COULTER LH 750 ANALYZER. THE USER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LAB COAT, GLOVES AND GOGGLES AT THE TIME OF THE INCIDENT. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR ASSOCIATED TO THIS COMPLAINT.

    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