BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3972095 · Received July 31, 2014

    Report

    Report Number
    1061932-2014-01777
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE STATED THAT THE CUSTOMER OBSERVED A LEAK FROM THE TUBING THROUGH PINCH VALVE (PV49). THE FSE VERIFIED THAT THE CUSTOMER HAD REPLACED THE TUBING WHICH RESOLVED THE ISSUE. THE FSE PERFORMED INSTRUMENT VERIFICATION AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY 50 MLS OF BLUISH COLORED FLUID LEAKED AROUND PINCH VALVE (PV49) INSIDE THE COULTER LH 500 HEMATOLOGY ANALYZER ONTO THE COUNTERTOP. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER STATED THAT THE INSTRUMENT GENERATED "DILUENT COMPARISON OUT OF LIMITS" ERROR. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE OCCURRENCE. 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
    448003 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1