BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 4233359 · Received November 6, 2014

    Report

    Report Number
    1061932-2014-02775
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 15, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    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

    THE FIELD SERVICE ENGINEER (FSE) NOTICED A SMALL FLUID LEAK AROUND THE TOP OF THE DIFF MIX CHAMBER. THE LEAK HAD NOT GONE PASSED THE RIM OF THE MIX CHAMBER. THE FSE REPLACED THE MIX CHAMBER AND ALL TUBING ASSOCIATED WITH THE MIX CHAMBER. THE FSE FLUSHED THE VACUUM SYSTEM AND VERIFIED ALL THE ACTUATORS ON THE DIFF MODULE WERE FUNCTIONING PROPERLY. THE FSE PERFORMED MULTIPLE PATIENT SAMPLES AND QUALITY CONTROL (QC) WHICH PRODUCED EXPECTED RESULTS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. (B)(6). ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 1061932-2014-02773, 1061932-2014-02774, 1061932-2014-02775.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NEUTROPHIL (NE) AND LYMPHOCYTE (LY) RESULTS DID NOT CORRELATE WITH THE RETEST RESULTS, FOR THREE PATIENTS, INVOLVING THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THIS REPORT IS THREE OF THREE REFERENCING THE PATIENT ON THE EVENT DATE NOTED. THE CUSTOMER STATED THE FIRST INCORRECT DIFF RESULT WAS REPORTED TO THE PHYSICIAN. THE PHYSICIAN THEN REQUESTED THE SAMPLE BE REANALYZED WHICH YIELDED RESULTS THAT DID NOT CORRELATE. THERE WAS NO PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE PATIENT'S SAMPLE WAS COLLECTED IN 3 ML BECTON DICKINSON (BD) TUBE AND STORED AT ROOM TEMPERATURE. THE SAMPLE WAS APPROXIMATELY FIVE MINUTES OLD, FOLLOWING COLLECTION. THE CUSTOMER NOTED CONTROLS WERE WITHIN SPECIFICATION PRIOR TO AND FOLLOWING THE 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
    713360 COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1