BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 2180895 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00680
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    December 29, 2009
    Report Date
    December 29, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPLACED ALL LOW VACUUM PINCH VALVE TUBING, THE BLOOD SAMPLING VALVE ACTUATOR AND THE PNEUMATIC MONITORING BOARD TO RESOLVE LOW VACUUM ISSUES. THE FSE THEN VERIFIED INSTRUMENT'S OPERATION. ALTHOUGH SEVERAL PARTS WERE REPLACED THE SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ERRONEOUSLY LOW WHITE BLOOD CELL (WBC) COUNTS WERE GENERATED BY THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER FOR TWO PATIENT SAMPLES. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER NOTICED THAT THE WBC RESULTS DID NOT MATCH THE PATIENTS' DIAGNOSIS AFTER REVIEWING THE RESULTS. THE SAMPLES WERE RE-RUN ON THE SAME SYSTEM AND ON ANOTHER LABORATORY REFERENCE SYSTEM AND THE RESULTS OBTAINED WERE WITHIN EXPECTATION FOR THE PATIENTS' DIAGNOSIS. THE REFERENCE INSTRUMENT'S PATIENT DATA WAS NOT PROVIDED. THE CORRECTED RESULTS WERE REPORTED OUT. THERE WAS NO DEATH, INJURY OR CHANGE TO THE PATIENTS' CARE OR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK