BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3895533 · Received June 25, 2014

    Report

    Report Number
    1061932-2014-01448
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 1, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 OBSERVED A LEAK IN THE TUBING AT PINCH VALVE (PV37). THE CUSTOMER WAS ABLE TO TROUBLESHOOT THE LEAK WITH HELP FROM THE CUSTOMER TECHNICAL SPECIALIST (CTS) OVER THE PHONE. THE CUSTOMER REPLACED THE TUBING AND THE INSTRUMENT PERFORMED WITHOUT ANY LEAKS. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY 1 TO 2 ML OF BLUE FLUID LEAKED UNDERNEATH THE COULTER LH 500 HEMATOLOGY ANALYZER AND AMBIENT TEMPERATURE ERRORS WERE GENERATED. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING GLOVES, GOGGLES AND A LAB COAT AT THE TIME OF THE INCIDENT. THERE WAS NO REPORTED EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. 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
    370410 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1