BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3915064 · Received July 6, 2014

    Report

    Report Number
    1061932-2014-01595
    Event Type
    Malfunction
    Date Received
    July 6, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPLACED THE BSV (BLOOD SAMPLING VALVE) AND RESOLVED THE ISSUE. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO THE BLOOD SAMPLING VALVE. A DEFINITIVE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER REPORTED INSTRUMENT FLAGGED WHITE BLOOD CELL (WBC) VOTE-OUTS (NON-NUMERICAL) RESULTS, ON PATIENT SAMPLES, INVOLVING THE COULTER LH 500 HEMATOLOGY ANALYZER. THE CUSTOMER STATED NO ERRONEOUS PATIENT RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393069 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1