BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 5851838 · Received August 5, 2016

    Report

    Report Number
    1061932-2016-00695
    Event Type
    Malfunction
    Date Received
    August 5, 2016
    Date of Event
    July 20, 2016
    Report Date
    July 20, 2016
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON 07/20/2016. THE FSE FOUND LEAK AT PV37 TUBING. HE REPLACED PV37 TUBING AND THE INSTRUMENT RAN WITHOUT ANY LEAKS. UPON RUNNING QC, FOUND 5CA2 CONSISTENTLY GAVE NO RESULTS FOR ANY PARAMETER IN AUTO, BUT NO MANUAL MODE. HE ORDERED A NEW QC WHICH FIXED THE ISSUE. PER HQC DATA ATTACHED, THERE IS NO ISSUE WITH 1028882K 5C CELL CONTROL. THE REPAIRS WERE VERIFIED PER ESTABLISHED SERVICE PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNCONTAINED CLENZ LEAK OF APPROXIMATELY 100 ML FROM A COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THERE WERE MODE-MODE DISCREPANCY AND 5CA2 QUALITY CONTROL (QC) MISSING RESULTS REPORTED BY THE CUSTOMER AT THE TIME OF THE EVENT. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT. THERE WAS NO IMPACT TO PATIENT RESULTS AND CONTROLS. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LABORATORY COAT AND GLOVES AT THE TIME OF THE EVENT AND THERE WAS NO REPORT OF INJURY OR BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502527 COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1