BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 4022295 · Received August 19, 2014

    Report

    Report Number
    1061932-2014-01996
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    July 31, 2014
    Report Date
    July 31, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE FOUND THE LEAK WAS CAUSED BY A PINHOLE IN THE SAMPLE DIFF TUBING AT THE BLOOD SAMPLING VALVE (BSV). THE FSE REPLACED THE TUBING AND THE INSTRUMENT RAN WITHOUT ANY LEAKS AND ERROR MESSAGES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BLOOD LEAK THAT WAS NOT CONTAINED WITHIN THE COULTER LH 500 HEMATOLOGY ANALYZER. THE INSTRUMENT DID NOT GENERATE ANY ERROR MESSAGES. THERE WAS NO REPORT OF DIRECT CONTACT WITH THE LEAK. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GOWN, GLOVES, AND GOGGLES. NO ERRONEOUS RESULTS WERE GENERATED FROM THIS EVENT. A FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AT THE CUSTOMER'S SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499176 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1