BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3842264 · Received June 1, 2014

    Report

    Report Number
    1061932-2014-01182
    Event Type
    Malfunction
    Date Received
    June 1, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE FOUND AND REPLACED DAMAGED TUBINGS TO TWO PINCH VALVES TO RESOLVE THE LEAK. THE FSE PERFORMED VERIFICATION OF THE INSTRUMENT TO MEET SPECIFICIZED REQUIREMENTS PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT CLENZ SOLUTION LEAKED FROM A COULTER LH 500 HEMATOLOGY ANALYZER ONTO A COUNTER IN THE LABORATORY. THE INSTRUMENT WAS NOT PROCESSING PATIENT SAMPLES AT THE TIME AND THERE WERE NO ERRONEOUS RESULTS GENERATED IN CONNECTION WITH THE LEAK. THE OPERATOR WAS WEARING A LAB COAT, GLOVES, AND GOGGLES. THERE WERE NO REPORTS OF DIRECT CONTACT WITH THE LEAK OR OF INJURY AS A RESULT OF THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320615 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1