BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 2445011 · Received February 9, 2012

    Report

    Report Number
    1061932-2012-00481
    Event Type
    Malfunction
    Date Received
    February 9, 2012
    Date of Event
    January 23, 2012
    Report Date
    January 23, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODE - RESULTS CODE - (OTHER): PROBE WIPE ASSEMBLY WAS OUT OF ADJUSTMENT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED ON (B)(4) 2012 REPORTING OF A SMALL VOLUME (< 1CC) OF CLEAR LIQUID DRIP COMING FROM THE MANUAL PROBE OF THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. CUSTOMER INDICATED THAT TESTING OF MODE TO MODE COMPARISON WAS OUT OF SPECIFICATION USING CONTROL MATERIAL. CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, A LAB COAT AND FACE PROTECTION WHILE TROUBLESHOOTING AND NO INJURY OR EXPOSURE WAS REPORTED. CUSTOMER STATED THAT PATIENT RESULTS WERE NOT AFFECTED BY THE LEAK AND THERE WAS NO CHANGE TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT. FIELD SERVICE ENGINEER WAS DISPATCHED AND CONFIRMED THE LEAK. FSE PROCEEDED TO ADJUST THE PROBE WIPE ASSEMBLY AND CLEANED THE TUBE AREA AND NO FURTHER LEAKING WAS OBSERVED. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. ROOT CAUSE FOR THE MANUAL PROBE LEAK WAS THE PROBE WIPE ASSEMBLY WAS OUT OF ADJUSTMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1