BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 2905650 · Received January 9, 2013

    Report

    Report Number
    1061932-2013-00028
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 12, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) NOTED THE BLOOD SAMPLING VALVE (BSV) WAS NOT ROTATING DUE TO A DEFECTIVE BSV ACTUATOR. THE FSE REPLACED THE ACTUATOR, BSV, TUBING, AND SOLENOIDS 16, 17, 18, AND 19. THE FSE VERIFIED THE REPAIR PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCORDANT HEMOGLOBIN AND HEMATOCRIT RESULTS, FOR SEVERAL PATIENTS, INVOLVING THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE PATIENT SAMPLES WERE ANALYZED BY A REFERENCE LABORATORY AND RECOVERED HEMOGLOBIN AND HEMATOCRIT RESULTS THAT WERE CONSIDERED CORRECT. THE ERRONEOUS RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. CONTROLS WERE WITHIN SPECIFICATION AT THE TIME OF THE EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12694 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1