BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX AUTOLOADER ANALYZER

    MDR report key: 2022866 · Received March 17, 2011

    Report

    Report Number
    1061932-2011-00163
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K922704
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE COLLECTION OR STORAGE INFORMATION WAS PROVIDED. CONTROLS WERE RUN BEFORE AND AFTER THE EVENT, AND WERE WITHIN ACCEPTABLE LIMITS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011 FOR THIS EVENT. THE FSE REPLACED THE PAK LYSE AND PRIMED THE SYSTEM. THE FSE ALSO RAN CONTROLS AND ADJUSTED THE SHEATH FLOW TO OPTIMIZE COUNT TIMES. THE FSE REVISITED AND INDICATED THAT THE MIXING MODULE HAD THREE STICKY ACTUATOR VALVES. THE FSE REPLACED THEM AND CONFIRMED THAT THE ISSUES WERE RESOLVED. ROOT CAUSE IS UNKNOWN. PER LABELING, USE ALL THE FLAGGING OPTIONS (SUSPECT, DEFINITIVE, HIGH/LOW, PARAMETER CODES AND THE LABORATORY'S FLAGGING CRITERIA) TO OPTIMIZE THE SENSITIVITY OF THE INSTRUMENT RESULTS. DO NOT SINGLE OUT ONE MESSAGE OR OUTPUT, SUCH AS A HISTOGRAM OR SCATTERPLOT, TO SUMMARIZE THE SPECIMEN OR PATIENT'S CONDITION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE COULTER® HMX AUTOLOADER ANALYZER OCCASIONALLY GENERATED ERRONEOUS DIFFERENTIAL RESULTS WITH OR WITHOUT INSTRUMENT GENERATED FLAGS. THE RESULTS YIELDED EITHER HIGH MONOCYTES (MO%) OR BASOPHILS (BA%), OR LOW NEUTROPHIL (NE%) RESULTS. MANUAL DIFFERENTIAL RESULTS SHOWED LOWER RESULTS FOR MO% OR BA% AND HIGHER NE% WHEN COMPARED TO INSTRUMENT RESULTS. THERE WERE NO ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY. THERE WAS NO DEATH, SERIOUS INJURY, OR CHANGE TO PATIENT TREATMENT IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® HMX AUTOLOADER ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. HMX AL 115V N/A

    Patients

    Seq Age Sex Outcome Treatment
    1