BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3920386 · Received July 8, 2014

    Report

    Report Number
    1061932-2014-01583
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 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 NOT DISPATCHED TO THE SITE FOR THIS EVENT. THE CUSTOMER BEGAN TO TROUBLESHOOT THE LEAK WITH HELP FROM THE CUSTOMER TECHNICAL SERVICE (CTS) OVER THE PHONE. THE CUSTOMER REPLACED DISCONNECTED ASPIRATION TUBING IN THE VICINITY OF THE NEEDLE CARTRIDGE, RESOLVING THE LEAK AND ASPIRATION ERRORS. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY 10 MLS OF DILUENT LEAKED FROM THE COULTER LH 500 HEMATOLOGY ANALYZER. THE CUSTOMER STATED ALL RESULTS WERE ZERO RECOVERED FOR ALL PARAMETERS ON PATIENT SAMPLES, ACCOMPANIED BY ASPIRATION P-FLAGS. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A FACE SHIELD AT THE TIME OF THE OCCURRENCE. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THE REPORTED EVENT. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER OR TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397782 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1