BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2542277 · Received April 19, 2012

    Report

    Report Number
    1061932-2012-01208
    Event Type
    Malfunction
    Date Received
    April 19, 2012
    Date of Event
    March 25, 2012
    Report Date
    March 25, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC (BEC) THAT THE COULTER LH 500 HEMATOLOGY ANALYZER WAS GIVING TUBE FORWARD ERRORS. CUSTOMER REPORTED THAT WHEN THEY OPENED UP THE UNIT, THEY FOUND SIGNS OF AN ACTIVE LEAK. CUSTOMER REPORTED THAT THE LEAK SEEMED TO HAVE BEEN GOING ON FOR SOME TIME NOW. CUSTOMER INDICATED THAT THE LEAK WAS COMING FROM AROUND THE NEEDLE AREA. CUSTOMER REPORTED THAT THE LEAK WAS CONTAINED IN UNIT. CUSTOMER REPORTED THAT THE VOLUME OF THE LEAK WAS LESS THAN 1 ML. CUSTOMER REPORTED THAT PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) REPLACED THE NEEDLE, NEEDLE DRAIN CHECK VALVE, AND TUBING. THE FSE VERIFIED INSTRUMENT OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1