BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 1961534 · Received January 14, 2011

    Report

    Report Number
    1061932-2011-00029
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN 4ML BD EDTA VACUTAINER TUBES AND SAMPLED WITHIN 5-10 MINUTES OF COLLECTION. QC WAS RAN BEFORE THE EVENT AND RECOVERED WITHIN ASSAY LIMITS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE FOUND THE 30 PSI REGULATOR WAS NOISY AND MOISTURE WAS FOUND ON THE OUTPUT LINES. THE FSE REPLACED THE REGULATOR AND MEMBRANE DRIER. THE FSE REPLACED THE E-LYSE AND S-LYSE PUMPS AND VERIFIED THE INSTRUMENT'S OPERATION. ROOT CAUSE FOR THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUS DIFFERENTIAL RESULTS GENERATED BY THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER FOR TWO PATIENT SAMPLES. THE SAMPLES OF BOTH PATIENTS WERE RE-TESTED AND REPEATED RESULTS WERE CONSIDERED CORRECT. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. THERE WAS NO CHANGE TO PATIENT TREATMENT, DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1