BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 4288185 · Received December 1, 2014

    Report

    Report Number
    1061932-2014-02867
    Event Type
    Malfunction
    Date Received
    December 1, 2014
    Date of Event
    November 4, 2014
    Report Date
    November 4, 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

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE FOUND THE PROBE WAS BENT, WHICH PREVENTED FULL TRAVEL OF THE PROBE WIPE ASSEMBLY (RB1). THE FSE STRAIGHTENED THE PROBE AND ADJUSTED THE PROBE WIPE TO RESOLVE THE ISSUE. THE INSTRUMENT WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY ONE (1) TO TWO (2) ML OF DILUTED BLOOD LEAKED FROM THE PROBE WASH OF A COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE CUSTOMER STATED THE PROBE WASH DID NOT COME ALL THE WAY DOWN TO THE END OF THE PROBE. THE INSTRUMENT OPERATOR WAS WEARING GLOVES AND A LAB COAT. THERE WERE NO REPORTS OF BIOHAZARD EXPOSURE TO THE LEAK. THERE WERE NO ERRONEOUS RESULTS GENERATED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775511 COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1